Latest Press Release

ICH Assembly, Montreal, Canada, May/June 2017

Mon, 19 Jun 2017 09:54:00 +0200

The Association begins new work on medicines for children and better clinical trials and China Food and Drug Administration joins ICH. The International Council for Harmonisation (ICH) met in Montreal, Canada on 27 May to 1 June 2017. Among other decisions, the ICH Assembly approved the China Food and Drug Administration (CFDA) as a new Regulatory Member, and Pharmaceutical Inspection Co-operation Scheme (PIC/S) as a new Observer. With these new parties, there are now 14 members and 23 observers, and full details are available on the ICH website www.ich.org. Paediatric medicines and modernisation of GCP principles to be new topics for ICH The ICH Assembly agreed to begin work on two new topics. The first is for a new international harmonised guideline on extrapolation for paediatric medicines. The new Working Group will further advance the use of paediatric extrapolation, which is the focus of the new ICH E11(R1) guideline currently under development. The aim is to provide guidance on incorporating extrapolation methods in an overall approach to paediatric medicinal product development. A harmonised approach to the appropriate use of extrapolation from adult data will improve the speed of access to new drugs for children. The second new topic is the revision of the 1997 ICH E8 guideline on general considerations for clinical trials. This is part of the strategic ‘GCP renovation’ announced at the November 2016 Osaka meeting. The revision will look at study design, planning and conduct, with a focus on identifying and supporting a basic set of critical-to-quality factors. Improved clinical trials contribute to public health by generating better evidence to inform regulatory decision-making, by avoiding the need for repeat trials and unnecessary exposure for trial participants, and helping to avoid discontinuation of promising development programs. Final guidelines The final M7(R1) addendum to the guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk was adopted by the ICH Assembly at Step 4 of the ICH process. The addendum provides a list of compounds for which mutagenic potential and the threshold of toxicological concern have been established. The ICH Assembly adopted at Step 4 the update of the Questions and Answers on the implementation guide package of the guideline E2B(R3): Electronic Transmission of Individual Case Safety Reports. Remaining agile as ICH grows With a view to streamlining the operation of ICH, the Assembly made some revisions to the Articles of Association and rules of procedure. With a growing number of members and observers, the changes include caps on the size of Expert Working Groups to ensure they remain a manageable size and revisions to the criteria for an international organisation to become an Observer. ICH aims to attract and engage with all organisations that are impacted by ICH harmonisation and that can bring value to its work; the revised criteria try to make sure that ICH is engaging with relevant global umbrella organisations at the highest level of representation. In Montreal, the Assembly also welcomed Standing Observer IFPMA’s plan to initially use its seat on ICH Working Groups to facilitate the participation of IFPMA National Association experts in Working Groups. The next ICH meeting will take place on 11 – 16 November 2017 in Geneva, Switzerland. ******************************** NOTES FOR EDITORS This press release, together with more information on the guidelines mentioned above and the work of ICH, can be found on its website: www.ich.org For further information, please contact the ICH Secretariat at pressrelease@ich.org Follow ICH on Twitter @ICH_News Download the PDF version of the Press Release

MedDRA Management Board, Montreal, Canada, May 2017

Mon, 12 Jun 2017 10:11:00 +0200

Montreal, Canada 2017 – The MedDRA Management Board met in Montreal, Canada on 27-28 May 2017. Expansion of MedDRA Use The MedDRA Maintenance and Support Services Organization (MSSO) and the Japanese Maintenance Organization (JMO) reported on the growth of their subscriber bases. The number of subscribing organizations to MedDRA is now over 5,000 in 103 countries. This reflects the successful adoption of MedDRA as a worldwide standard in the protection of public health. Future areas of focus for the MSSO include continuing to support the global use of MedDRA and exploring interoperability between MedDRA and other medical terminologies. Coordination with the WHO Collaborating Centre for International Drug Monitoring The Board noted that the MSSO and the WHO Collaborating Centre for International Drug Monitoring (Uppsala Monitoring Centre) held their first joint MedDRA and WHODrug User Group meetings in Bangalore and Mumbai, India in February 2017. Following this succcessful collaboration, another joint MedDRA/WHODrug meeting is planned for Beijing, China in September 2017. ICH M1 Points to Consider The Board noted the efforts of the ICH M1 Points to Consider (PtC) Working Group in supporting MedDRA’s global uptake. The Working Group has developed condensed versions of the PtC documents for translation into all MedDRA languages (English and Japanese versions will remain in full) to support the implementation and use of MedDRA worldwide. These condensed documents will be made available to MedDRA users in 2017. The Board also noted that the Working Group has begun development of a companion document to the PtC documents, available in English and Japanese. This document will provide more detailed guidance, examples, and “Questions and Answers” on topics of regulatory importance such as data quality and medication errors. The first edition of the companion document is expected to be available in 2018. Software Tools The MSSO reported that the MedDRA Self-Service Application was launched in April 2017. This web-based tool allows MedDRA users to retrieve subscription information and passwords, confirm the subscription status of business partners, and obtain certificates for attending face-to-face training classes. Standardised MedDRA Queries (SMQs) The Board acknowledged the significant work of the CIOMS SMQ Implementation Working Group (IWG) and noted that one new SMQ Infective pneumonia will go into production in September 2017 for MedDRA Version 20.1. The Board was also updated on other important initiatives and developments. The MSSO reported on its participation in the Innovative Medicines Initiative’s WEB-RADR (Recognising Adverse Drug Reactions) project and the development of a draft set of “patient friendly terms” to support direct patient reporting through mobile applications and web portals. The next scheduled meeting of the Board will be on 11-12 November 2017 in Geneva, Switzerland. For further information, please contact:

ICH Secretariat
Chemin des Mines 9
P.O Box 195, 1211 Geneva 20, Switzerland
Tel: +41 22 338 3206
Fax: +41 22 338 3230
E-mail: PressRelease@ich.org - Websites: www.ich.org / www.meddra.org Download the PDF version of the Press Release

ICH Reflection on “GCP Renovation”: Modernization of ICH E8 and Subsequent Renovation of ICH E6

Thu, 12 Jan 2017 10:07:00 +0100

ICH is inviting public review and comment on a reflection paper on Good Clinical Practice (GCP) "Renovation", which contains the ICH proposal for further modernization of the ICH Guidelines related to clinical trial design, planning, management, and conduct. The scope of the proposed renovation includes the current E8 General Considerations for Clinical Trials and further revision to the E6 Guideline for Good Clinical Practice, which is already undergoing modernization with the recent production of ICH E6(R2). The reflection paper is available for download via the following link:

Reflection paper on GCP Renovation

The goal of the potential renovation is to provide updated guidance that is both appropriate and flexible enough to address the increasing diversity of study types and data sources that are being employed to support regulatory and other health policy decisions, as appropriate. The underlying principles of human subject protection and data quality would remain. ICH’s decision to invite stakeholder comment on the proposed renovations at this early stage, ahead of guideline development efforts, recognises the considerable stake and relevant expertise in the research community beyond ICH. The seeking of stakeholder comment on the current reflection paper is seen as a first step in an enhancement of the ICH process with respect to public consultation for the revision of ICH E8 and E6. The GCP Renovation reflection paper outlines additional steps that are also being considered to enhance stakeholder engagement. Stakeholders are invited to submit any comments to gcprenovation@ich.org. All comments should be submitted before the closing date for public comment, which is March 11, 2017. ICH will review the comments received to determine whether to make revisions to the currently proposed approach. The aim is to proceed with initiating needed renovation work as soon as practical, for example, within the next year. Download the PDF version of the Press Release

MedDRA Management Board, Osaka, Japan, November 2016

Fri, 18 Nov 2016 12:22:00 +0100

Osaka, Japan 2016 – The MedDRA Management Board met in Osaka, Japan on 5-6 November 2016. MedDRA Subscriptions The Board is pleased to announce that there will be a reduction in MedDRA subscription rates for MSSO subscribers in 2017. Details will be available on the MedDRA website. This reduction is a reflection of the continued success of MedDRA as a global standard; with over 4,800 subscribing organisations worldwide, the costs of maintaining and developing the terminology can be distributed over a wider base, whilst still providing the same high standard of tools and services to MedDRA users. Standardised MedDRA Queries Five Standardised MedDRA Queries (SMQs) will go into production in March 2017 for MedDRA Version 20.0. The Board acknowledged the significant efforts of the Council for the International Organization of Medical Sciences (CIOMS) SMQ Implementation Working Group (IWG) and renewed the Memorandum of Understanding between ICH and CIOMS for a further year of development of new SMQs. In addition, the Board noted the publication of the second edition of the CIOMS SMQ IWG report, Development and Rational Use of Standardised MedDRA Queries (SMQs): Retrieving Adverse Drug Reactions with MedDRA. This report was made available in August 2016 on the CIOMS website. ICH M1 Points to Consider The Board noted the work of the ICH M1 Points to Consider (PtC) Working Group in facilitating MedDRA’s global uptake. The Working Group has developed condensed versions of the PtC documents for translation into all MedDRA languages (except English and Japanese versions which will remain in full) to support the implementation and use of MedDRA worldwide. These condensed documents will be made available to MedDRA users in 2017. The Board also approved the Working Group’s proposal to develop a companion document to the PtC documents, available in English and Japanese, which would provide more detailed guidance, examples, and “Questions and Answers” on topics of regulatory importance such as data quality, medication errors, and product quality issues. Unqualified Test Name Term List The Board noted that the MSSO has published a list of unqualified test name terms as a toto improve data quality. The list and an explanatory document are available under RelatedLinks on the Support Documentation page on the MedDRA website. MSSO ISO Recertification The Board noted that the MSSO achieved ISO 9001 recertification in August 2016 followsuccessful completion of an audit. Other important initiatives and developments The Board was also updated on other important initiatives and developments. This includethe development of a web-based self service application which will allow users to access MedDRA subscription information online; and MSSO participation in the Innovative Medicines Initiative’s WEB-RADR (Recognising Adverse Drug Reactions) project lookinat the integration of MedDRA in mobile technologies and social media data monitoring asnew tools in pharmacovigilance; The next scheduled meeting of the Board will be on 27-28 May 2017 in Canada. For further information, please contact:

ICH Secretariat
Chemin des Mines 9
P.O Box 195, 1211 Geneva 20, Switzerland
Tel: +41 22 338 3206
Fax: +41 22 338 3230
E-mail: admin@ich.org - Websites: www.ich.org / www.meddra.org Download the PDF version of the Press Release

ICH Assembly, Osaka, Japan, November 2016

Thu, 17 Nov 2016 16:50:00 +0100

First new regulatory Members of ICH, key global good clinical practice guideline revisions agreed The International Council for Harmonisation (ICH) met in Osaka, Japan on 5-10 November 2016. As part of the objective to extend its global outreach, ICH is pleased to welcome the Agência Nacional de Vigilância Sanitária (ANVISA) from Brazil and the Ministry of Food and Drug Safety (MFDS) from South Korea as the first new regulatory Members, together with the Biotechnology Innovation Organization (BIO) as a new industry association Member. In addition, the following regulatory authorities and international pharmaceutical industry organisation were agreed as ICH Observers:

Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED), Cuba
National Center for the Expertise of Drugs, Medical Devices and Equipment (National Center), Kazakhstan
Medicines Control Council (MCC), South Africa
Active Pharmaceutical Ingredients Committee (APIC)

There are now 13 members and 22 observers, and full details are available on the ICH website www.ich.org.

Global good clinical practice (GCP) guideline amendment adopted The 1996 ICH guideline on GCP is one of the most significant achievements of the ICH process, establishing harmonised standards for clinical trials. The ICH Assembly adopted an important amendment (ICH E6(R2)) that aims to encourage sponsors to implement improved oversight and management of clinical trials, while continuing to ensure protection of human subjects participating in trials and clinical trial data integrity. This amendment will now be implemented by ICH members through national and regional guidance. In parallel, the Assembly agreed to look at renewing the wider package of guidelines that relate to GCP and clinical trial design. This will include updating current guidance on interventional trials and expand on novel trial methodologies for drug registration such as non-interventional trials, including use of new data sources such as real world evidence, patient registries, etc. A reflection paper is expected to be published on the ICH website in early 2017, which will include an outline of the long-term work planning, beginning with revision of the ICH E8 guideline in 2017. ICH recognises the high level of interest in GCP guidance and is committed to working with concerned stakeholders and will be seeking views as work goes forward. Optimising safety data collection Recognising the increased interest in collecting data on the long-term effects of drugs, the Assembly also decided to begin work on development of a new guideline on optimisation of safety data collection. The new guideline (future ICH E19) is expected to harmonise requirements on the optimal collection of safety data during late stage pre-market and post-approval clinical investigations of new drugs and new indications for approved drugs. This will improve global health by encouraging study on long-term effects, rare events and new indications of drugs through reducing resources required for these studies. ICH Members will also seek to work closely with stakeholders, especially patient representatives, in the development of this guideline. Other decisions Individual case safety reports (ICSRs) have an important role in supporting drug safety surveillance by regulators around the world. The Assembly agreed to an update on the implementation guide for the ICH ICSR guideline (ICH E2B(R3)) as well as the Q&A document. These documents will be published on the ICH website shortly. The Assembly acknowledged the positive collaboration with the European Directorate for the Quality of Medicines & HealthCare (EDQM) in the use of terminologies for routes of administration and dose forms. Following on from the adoption of the 2012 guideline on development and manufacturing of drug substances (ICH Q11), a question and answer document has been developed to clarify a number of implementation issues, particularly focusing on chemical entity drug substances. The draft document will now be released for stakeholder consultation. A new update of the ICH guideline on residual solvents (ICH Q3C(R6)) was finalised and adopted for implementation by ICH members. There were also decisions relating to the eCTD guideline (ICH M8), with adoption of a new ICH eCTD v4.0 Implementation Package v1.2 and related documents. For further details on progress made on other guidelines at the meeting, please see the ICH Assembly Report published on the ICH website. Next ICH meeting will take place on 27 May – 1 June 2017 in Montreal, Canada.
******************************** NOTES FOR EDITORS This press release, together with more information on the guidelines mentioned above and the work of ICH, can be found on its website: www.ich.org For further information, please contact the ICH Secretariat at pressrelease@ich.org Follow ICH on Twitter @ICH_News Download the PDF version of the Press Release

MedDRA Management Board, Lisbon, Portugal, June 2016

Wed, 20 Jul 2016 17:47:00 +0200

The ICH MedDRA Management Board met in Lisbon, Portugal on June 11-12, 2016 where ICH concluded its internal process for the award of a new 7-year contract for the MedDRA Maintenance and Support Services Organization (MSSO). MedDRA, the Medical Dictionary for Regulatory Activities, is a rich and highly specific standardised medical terminology developed by ICH to facilitate sharing of regulatory information internationally for medical products used by humans. It is used for registration, documentation and safety monitoring of medical products both before and after a product has been authorised for sale. The ICH MedDRA Management Board provides technical and financial oversight. The MSSO is contracted by ICH and tasked with maintaining, developing and distributing MedDRA. A new call for tender was launched by ICH in August 2014, with bids invited by October 31, 2014. After a thorough period of assessment, which considered aspects including medical expertise and IT expertise, strength of management and staffing that are necessary to ensure the high quality of MedDRA as well as financial aspects, the ICH’s Tender Evaluation Panel concluded the negotiation of a new contract with the selected bidder. ICH is pleased to announce that a new 7-year contract has been awarded as a result of which Northrop Grumman’s Health Solutions Business Unit will serve as the MSSO whose team is well qualified and experienced since it is already in charge of current MSSO operations. The awarding of the new contract assures the continued viability and growth of the unique asset that is MedDRA. In Lisbon, the Board acknowledged MedDRA’s success with the further growth in the number of MedDRA subscribers worldwide to over 4,500 organisations. The Board also discussed further facilitating MedDRA’s global uptake. Current work by the ICH M1 Points to Consider (PtC) Working Group was recognised as important in this regard. The Working Group, which also met in Lisbon (June 13-16), discussed the development of condensed versions of the PtC documents for translation into all MedDRA languages (except English and Japanese versions which will remain in full) to support the implementation and use of MedDRA worldwide. The Board was also updated on other important initiatives and developments. This included a smooth implementation of the 27th SOC Product issues in MedDRA Version 19.0 in March 2016; release in May 2016 of an updated MedDRA Web-Based Browser (WBB) with more multilingual features; MSSO participation in the Innovative Medicines Initiative’s WEB-RADR (Recognising Adverse Drug Reactions) project looking at the integration of MedDRA in mobile technologies and social media data monitoring as new tools in pharmacovigilance; and the successful achievement of ISO 9001 certification by the JMO (Japanese Maintenance Organisation) in December 2015. The next scheduled meeting of the Board will be on November 5-6, 2016 in Osaka, Japan. For further information, please contact:

ICH Secretariat
Chemin des Mines 9
P.O Box 195, 1211 Geneva 20, Switzerland
Tel: +41 22 338 3206
Fax: +41 22 338 3230
E-mail: admin@ich.org - Websites: www.ich.org / www.meddra.org Download the PDF version of the Press Release

ICH Assembly, Lisbon, Portugal, June 2016

Mon, 27 Jun 2016 10:21:00 +0200

ICH increases its global reach, moves forward on global drug development The International Council for Harmonisation (ICH) met in Lisbon, Portugal, 11-16 June 2016, bringing together regulators and industry from around the world. Building on the objective to establish itself as a truly global platform for harmonisation for better health, ICH formally welcomed 2 new Members and 14 Observers representing regulatory authorities, regional health initiatives and pharmaceutical industry. In addition to the 5 regulatory authorities and regional health initiatives announced in December 2015, ICH welcomed the following as new Observers:

Association of Southeast Asian Nations (ASEAN)
Biotechnology Innovation Organisation (BIO)
Central Drugs Standard Control Organization (CDSCO, India)
Council for International Organizations of Medical Sciences (CIOMS)
Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS, Mexico)
East African Community (EAC)
European Directorate for the Quality of Medicines & HealthCare (EDQM)
Health Sciences Authority (HSA, Singapore)
International Pharmaceutical Excipient Council (IPEC)
Ministry of Food and Drug Safety (MFDS, South Korea)
Roszdravnadzor (Russia)
Food and Drug Administration (TFDA, Chinese Taipei)
Therapeutic Goods Administration (TGA, Australia)
United States Pharmacopeia (USP)

Moreover, two new pharmaceutical industry bodies were welcomed, with International Generics and Biosimilars Association (IGBA) and World Self-Medication Industry (WSMI) accepted as Members[1]. Benefit-risk assessment, global drug development and other highlights With advances for public health in mind, highlights of the meeting included adoption of a final revised ICH guideline on format and structure of benefit-risk information in the common technical document (ICH M4E (R2)). Given the importance of benefit-risk assessment for drug regulation, this is expected to support regulatory decision-making through a more consistent description of information coming from clinical trial data, as well as other factors such as disease severity and availability of other treatment options. Recognising the increasing role of the patient voice in drug development and regulation, the revised guideline also opens the possibility to include information about patient perspectives, for example information from patient preference studies. This revised guideline will now be implemented by each of the ICH regulatory members. Another highlight was the endorsement of a draft guideline on multi-regional clinical trials (ICH E17). With the move to global development of medicines, the guideline is intended to support the planning and design of multi-regional clinical trials, a reduction in unnecessary duplication of studies and the subsequent acceptability to regulators of data from those trials. The draft guideline will now be released for stakeholder consultation, with adoption of the final guideline planned for 2017. The guideline on good clinical practice (ICH E6) was adopted in 1996. Designed to bring the guideline up to date, an integrated addendum (ICH E6 (R2)) reached Step 3 of the ICH process, with expert consensus on the principles and content. With formal adoption expected later in 2016, the addendum is designed to modernise ICH E6 to enable implementation of innovative approaches to clinical trial design, management, oversight, conduct, documentation, and reporting that will better ensure human subject protection and data quality. ICH also endorsed a draft question and answers document aimed at clarifying the 2009 ICH guideline on non-clinical evaluation of anticancer products (ICH S9 Q&A) that will now be released for stakeholder consultation. The questions and answers are intended to clarify the scope and implementation of the guideline, and support the development and evaluation of medicines for faster access for patients with serious and life-threatening cancers. New topics for international harmonisation Two new topics for international harmonisation were endorsed by the Assembly. The first is the development of a guideline on biopharmaceutical classification system-based biowaivers. The aim of the future ICH M9 Guideline is to achieve worldwide harmonisation of the applicability of biowaivers and the data needed to support such applications. The public health benefits include reducing unnecessary clinical trials, and facilitating the production and availability of good quality medicines especially in low and middle-income countries. The second new topic is related to bioanalytical method validation, for which recent regulatory requirements have been introduced in EU, Japan and USA. The proposed ICH M10 Guideline will address the discrepancies between these provisions and those from other ICH regulatory members. A harmonisation approach will promote rational and effective studies and facilitate global drug development, thereby advancing the mission of ICH. For further details on progress made on other guidelines at the meeting, please see the ICH Assembly Report published on the ICH website. The next ICH meetings will be held on 5-10 November 2016 in Osaka, Japan, and in Spring 2017 in Montreal, Canada, to be hosted by Health Canada for the first time. ******************************** NOTES FOR EDITORS This press release, together with more information on the guidelines mentioned above and the work of ICH, can be found on its website: www.ich.org For further information, please contact the ICH Secretariat at pressrelease@ich.org Follow ICH on Twitter @ICH_News Download the PDF version of the Press Release

[1] The list of all ICH Members and Observers is available on the ICH website.

ICH Assembly, Jacksonville, FL, USA, December 2015

Wed, 16 Dec 2015 17:13:00 +0100

Reformed ICH advances work on several key new guidelines Jacksonville, Florida, USA, 5-10 December 2015 The new International Council for Harmonisation (ICH) met in Jacksonville, USA, from 5 to 10 December 2015. In addition to its Expert Working Groups and Management Committee, the new ICH Assembly met in person for the first time, bringing together regulators and industry members, including observers from WHO, other regulators and industry associations. As part of increasing the international outreach and inclusiveness of ICH, one of the first points of business was to review the application process for new Members and Observers. More information about the procedure, including application forms, will be published on the ICH website. The Assembly also encouraged members of the former Global Cooperation Group to take the opportunity to automatically become Observers before 23 January 2016, a privilege provided by the Articles of Association. The Southern African Development Community (SADC), the Gulf Cooperation Council (GCC), the Agência Nacional de Vigilância Sanitária (ANVISA) of Brazil, the Pan American Network for Drug Regulatory Harmonization (PANDRH), and the Asia-Pacific Economic Cooperation (APEC) were welcomed as the first Observers under these new rules. The Assembly finalised its rules of procedure, which reflect the new emphasis on clearer governance, transparency and openness in the operation of the reformed ICH, and will be published shortly. Key advances for public health ICH aims to improve health through harmonisation of global regulatory requirements. Some of the key achievements at this meeting include progress made on developing a draft guideline for multi-regional clinical trials (ICH E17), advances on developing a Questions and Answers document to clarify requirements for non-clinical studies for anti-cancer drugs (ICH S9 Q&A) and agreement on a draft guideline on genomic sampling and management of genomic data (ICH E18). A draft revision to the Questions and Answers document on clinical evaluation of QT prolongation (ICH E14 Q&A (R2)) was approved. This Q&A aims to clarify and improve the use of concentration-response analysis principles for regulatory decision-making and possibly reduce the number of early phase trials. As part of ongoing work to revise the current ICH S1 guideline on rodent carcinogenicity testing, progress was made in clarifying regulators’ expectations for carcinogenicity assessment documents (CADs). Pharmaceutical companies planning to conduct carcinogenicity studies are encouraged to continue submitting CADs. It is hoped that these efforts will lead to changes in requirements for carcinogenicity studies by allowing waivers of such studies under certain circumstances. This can potentially accelerate the approval of new, safe, effective, and high-quality drugs, while reducing the use of animals and not compromising patient safety. To facilitate the application process for new medicines the ICH Assembly adopted the implementation package for the next major version of the electronic Common Technical Document (eCTD, ICH M8). Details about the progress of each working group that met in Jacksonville are outlined below. All concept papers and work plans for each topic are available on the ICH website (www.ich.org). Progress in ICH safety guidelines In addition to the call for submission of more CADs, the ICH S1 Expert Working Group reviewed the 25 CADs received to date and the process for reviewing CADs. It also worked on improving quality of data currently included in CAD submissions. Progress was made on a Questions and Answers document related to non-clinical evaluation of anti-cancer products (ICH S9 Q&A). Given the rapidly changing field of anti-cancer therapies, the Implementation Working Group will continue to work towards completing the draft document by the June 2016 ICH meeting. The Expert Working Group developing a new guideline on non-clinical safety testing in support of development of pediatric medicines (ICH S11) worked on drafting text for the guideline. The Expert Working Group revising the ICH S5(R3) guideline on detection of toxicity to reproduction for medicinal products and toxicity to male fertility continued its work on an extensive revision of this guideline to address advancements in a number of areas. Progress in ICH efficacy guidelines The Assembly adopted the draft guideline on genomic sampling and management of genomic data (ICH E18) for public consultation. The guideline sets out harmonised principles for genomic sampling and addresses issues relating to patient privacy and informed consent. The draft Questions and Answers document aiming at clarifying the use of concentration-response to evaluate the risk of QT/QTc interval prolongation was approved (ICH E14 Q&A (R2)). Progress was made on the draft addendum to the guideline on statistical principles for clinical trials (ICH E9) on providing a structured framework for improved clinical trial planning, conduct, analysis, and interpretation. Progress was made towards completing a draft of the guideline on multi-regional clinical trials (ICH E17) and ICH anticipates that the draft document will be signed-off for public consultation prior to the next face-to-face meeting in June 2016. Multi-regional clinical trials are generally the preferred option for investigating a new drug. This guideline will facilitate acceptance of multi-regional clinical trials in global regulatory submissions. Progress in ICH quality guidelines Work progressed on the draft guideline on pharmaceutical product lifecycle management (ICH Q12) and creation of a framework for effective quality management systems, and management of post-approval chemistry manufacturing and controls changes in a more predictable and efficient manner across the product lifecycle. This aims to optimise industry and regulator resources, to ensure continual improvement and contribute to assuring drug quality and availability. The next ICH meetings will be held from 11-16 June 2016 in Europe, and 5-10 November 2016 in Japan. ******************************** NOTES FOR EDITORS 1. For more details on the ICH reforms, see the ICH press release of 26 October 2015 here.
2. This press release, together with more information on the guidelines mentioned above, can be found on its website: www.ich.org For further information, please contact the ICH Secretariat at pressrelease@ich.org
Follow ICH on Twitter @ICH_News Download the PDF version of the Press Release

MedDRA Management Board, Jacksonville, FL, USA, December 2015

Mon, 14 Dec 2015 17:47:00 +0100

ICH MedDRA Management Board Notes New SOC and New SMQs for MedDRA Version 19.0 Jacksonville, 6 December 2015 – The MedDRA Management Board met in Jacksonville, FL, USA on 5-6 December 2015. SOC Product issues
The MSSO confirmed to the Board the implementation of the new System Organ Class (SOC) Product issues in March 2016 for MedDRA Version 19.0. This SOC will include terms relevant for issues with product quality, devices, manufacturing quality systems, product supply and distribution, and counterfeit products. One of the goals of incorporating product quality terms into MedDRA is to support the recording of product quality issues and any associated adverse events by using a single terminology. An initial set of terms in this new SOC is contained in the supplemental files which can be accessed now on the MedDRA website. Standardised MedDRA Queries
Four Standardised MedDRA Queries (SMQs) will go into production in March 2016 for MedDRA Version 19.0. Three SMQs are new topics: Drug reaction with eosinophilia and systemic symptoms syndrome, Hypoglycaemia, and Medication errors. The fourth, Pulmonary hypertension, is a revision of the existing SMQ based on a new classification of the condition. The Board acknowledged the significant efforts of the Council for the International Organization of Medical Sciences (CIOMS) SMQ Implementation Working Group (IWG) and renewed the Memorandum of Understanding between ICH and CIOMS for a further year of development of new SMQs. In addition, the Board endorsed the second edition of the CIOMS SMQ IWG report, « Development and Rational Use of Standardised MedDRA Queries (SMQs): Retrieving Adverse Drug Reactions with MedDRA”. This report is scheduled to be published in 2016 and can be obtained on the CIOMS website. MedDRA Subscriptions
The Board is pleased to announce that there will be no increase in MedDRA subscription rates for 2016. This is the result of continued growth of MedDRA subscribers throughout the world – currently numbering over 4,500 organisations - and increased efficiencies to contain costs of maintenance and development of the terminology. The Japanese Management Board reported on the Japanese Maintenance Organization’s (JMO) activities and noted an increase in the number of subscribers. WEB-RADR (Recognising Adverse Drug Reactions)
The MSSO reported that it has joined the Innovative Medicines Initiative’s WEB-RADR project as one of 20 contributing partners evaluating mobile technologies and social media as new tools in pharmacovigilance. Software Tools
The MSSO released an updated MedDRA Desktop Browser (MDB) in October 2015. This latest version of the MDB updates the user interface and the functions to match the Web-Based Browser (WBB). Additionally, the MDB includes an option to change the user interface to any of the currently supported MedDRA languages, as well as supporting multiple languages and the display of hierarchy information in search result outputs. The next scheduled meeting of the Board will be on 11-12 June 2016 in Europe. For further information, please contact:

ICH Secretariat
Chemin des Mines 9
P.O Box 195, 1211 Geneva 20, Switzerland
Tel: +41 22 338 3206
Fax: +41 22 338 3230
E-mail: admin@ich.org - Websites: www.ich.org / www.meddra.org Download the PDF version of the Press Release

ICH announces Organisational Changes

Mon, 26 Oct 2015 10:10:00 +0100

The International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation (ICH) held the inaugural meetings of its new Assembly [and Management Committee] on 23 October 2015. The reforms build on a 25-year track record of successful delivery of harmonised guidelines for global pharmaceutical development, and their regulation. The changes announced today build on that success and will reinforce the foundations of ICH to make it better-equipped to face the challenges of global pharmaceutical development and regulation. The reforms will mean that ICH is a truly global initiative, expanding beyond the current ICH members. More involvement from regulators around the world is welcomed and expected, as they will be invited to join counterparts from Europe, Japan, USA, Canada and Switzerland as ICH regulatory members. This is matched by the possibility of wider inclusion of global industry sectors affected by ICH harmonisation. The reforms strengthen ICH as the leading platform for global pharmaceutical regulatory harmonisation, and one that brings together in a transparent manner all key regulatory authorities and industry stakeholders. The changes give ICH a more stable operating structure through the establishment of an ICH association, a legal entity under Swiss law. The association establishes the new Assembly as the over-arching governing body that will be instrumental in facilitating future growth through the participation of new members. At the end of the inaugural meeting, ICH Assembly members declared “The fundamentals of what the ICH parties are trying to achieve are not changed, but the reforms to the process and organisation were needed to adapt to changes in how medicines are developed and regulated. These changes mark an exciting moment for us to help harmonise and streamline the global drug development process for the benefit of patients around the world.”

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NOTES FOR EDITORS 1. Current ICH membership includes the following 5 regulators: Health Canada (Canada), European Commission (EU), Ministry of Health Labor and Welfare/Pharmaceuticals and Medical Devices Agency (Japan), Swissmedic (Switzerland), Food and Drug Administration (USA). It also includes the following 3 industry members: European Federation of Pharmaceutical Industries and Associations (EU), Pharmaceutical Research and Manufacturers of America (USA) and Japan Pharmaceutical Manufacturers Association (Japan). 2. ICH has developed over 60 Guidelines to-date on Quality, Safety, Efficacy and Multidisciplinary topics, in addition to products including Electronic Standards for the Transfer of Regulatory Information (ESTRI), the Common Technical Document (CTD & eCTD), and the Medical Dictionary for Regulatory Activities (MedDRA). 3. This press release, together with more information on the work of ICH, can be found on its website: www.ich.org For further information, please contact the ICH Secretariat at pressrelease@ich.org. Download the Press Release.

ICH Steering Committee, Fukuoka, Japan, June 2015

Fri, 26 Jun 2015 15:31:00 +0200

The International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) met in Fukuoka, Japan from June 5-11, 2015. The meeting was hosted by the Ministry of Health, Labour and Welfare and the Japan Pharmaceutical Manufacturers Association. The SC agreed on the key issues relating to the reform of ICH in terms of the Articles of Association, funding model and membership. An important part of the reform effort is establishing a formal organisation with a new approach to membership, governance and shared funding among ICH members. During a special session on June 10, Interested Parties were updated on the future of ICH, including issues regarding membership and governance of the new association. All participants welcomed the goals of the reform and recognised the intended roles of the Assembly as well as the Management Committee. Most participants indicated their interest for becoming ICH members or observers and the different intended eligibility criteria were discussed. The new ICH Association under Swiss law is expected to be established over the coming months with the aim of being operational starting in 2016. Twelve working groups met in Fukuoka and achieved important progress towards their respective objectives. The Question & Answer (Q&A) document on the Q7 Guideline on Good Manufacturing Practices for Active Pharmaceutical Ingredients (APIs) has been signed off at Step 4 in Fukuoka and is thus ready for implementation in the ICH regions. In addition, two documents, the draft Addendum to the M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk document and the draft Addendum to E6 on Good Clinical Practice have reached Step 2b and will be submitted to public consultation. More details on the progress achieved by the different groups is provided hereunder. Safety Guidelines Update
The M7 EWG reached agreement on the draft Addendum to the Guideline Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk. The SC signed off the Step 2a/2b document in Fukuoka. thus releasing this document for public consultation. A new EWG, S5(R3), was created to revise the Guideline on Detection of Toxicity to Reproduction for Medical Products and Toxicity to Male Fertility and met in Fukuoka for the first time. This group made good progress in reviewing and revising the current guidance in developmental and reproductive toxicity studies and expects to reach Step 2 by June 2017. It was also the first meeting of the S11 EWG tasked to develop a new ICH Guideline on Nonclinical Safety Testing in Support of Development of Paediatric Medicines. Efficacy Guidelines Update
The EWG developing an Addendum to E6 on Good Clinical Practice to promote innovative approaches to clinical trial design, management, oversight and conduct made good progress and reached Step 2a/2b. The draft document that will take the format of an integrated addendum will now be submitted to public consultation. The EWG developing an Addendum to E9 on Choosing the Appropriate Estimand and Defining Sensitivity Analyses in Clinical Trials, met to focus on harmonising improved clinical trial planning, conduct, analysis and interpretation. The E11 EWG worked to develop an Addendum to the Guideline on Clinical Investigation of Medicinal Products in the Pediatric Population and made good progress towards the draft Step 1 technical document. Step 2 for this topic is expected in December 2015. The E14 Discussion Group (DG) met to develop a Concept Paper to revise the ICH E14 Guideline on the Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. During the meeting in Fukuoka, the SC endorsed the Concept Paper on the revision of the Q&A 5.1 on Concentration-Response Modelling for regulatory decision making thereby allowing experts to initiate this revision. The group working on the development of the E17 Guideline on Multi-regional Clinical Trials progressed towards developing the Step 1 technical document. The E18 EWG on Genomic Sampling Methodologies for Future Use made progress towards a Step 2 document which is expected in December 2015. This Guideline will clarify points to consider in collecting genomic samples in clinical trials, resulting in further implementation of genomic research for the benefit of all stakeholders. Quality Guidelines Update
The Q7 Implementation Working Group (IWG) on Good Manufacturing Practices for APIs reached agreement on the Step 3 Q&A document ahead of the Fukuoka meeting. The SC approved this document for release by signing off Step 4 in Fukuoka. The SC also signed-off on Step 2a/2b of the Q3C(R6) Guideline for Residual Solvents including two solvents: Triethylamine and Methyl Isobutyl Ketone. The Q3C maintenance EWG had reached agreement on this document ahead of the Fukuoka meeting The Q12 EWG on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management met for the second time in Fukuoka. This group is expected to finalise its Step 1 technical document in June 2016. The ICH SC approved an interim face-to face meeting of the Q11 IWG to develop Q&As on Selection and Justification of Starting Materials for the Manufacture of Drug Substances in September 2015. Multidisciplinary Guidelines Update
The M2 EWG on Electronic Standards for the Transfer of Regulatory Information (ESTRI) met in Fukuoka, making progress on a variety of issues. The M4E(R2) EWG working on the revision of the Common Technical Document (CTD) Efficacy Guideline to provide greater specificity on the format and structure of benefit-risk information also made progress to finalise a draft of its Step 1 technical document. The M8 EWG on electronic Common Technical Document (eCTD) met in Fukuoka and the SC signed-off at Step 4 of Version 1.27 of the eCTD Change Request Q&A document and endorsed that the M8 would update the Granularity Document based on Q&A from CTD-Quality and change requests M8 received. The M8 EWG reconciled all of the comments received on the draft eCTD Implementation Guide v.4.0 during Step 3. The next ICH meeting will be held in Jacksonville, Florida, USA on December 5 - 10, 2015. For further information, please contact the ICH Secretariat at admin@ich.org. Download the PDF version of the Press Release

MedDRA Management Board, Fukuoka, Japan, June 2015

Mon, 15 Jun 2015 17:15:00 +0200

ICH MedDRA Management Board Notes New MedDRA Tools Supporting Multiple Languages Fukuoka, 7 June 2015 – The MedDRA Management Board met in Fukuoka, Japan on 6-7 June 2015. Software Tools
The MSSO reported on the launch of the new Web-Based Browser (WBB). Feedback has been positive with a growing pool of users. The WBB supports all MedDRA languages, and allows users to view multiple languages simultaneously. The WBB features options for search result displays, and Research Bin import and export functions. A User Interface in all languages is planned in a future upgrade. The MSSO also reported on the release of an updated MedDRA Version Analysis Tool (MVAT) application in May 2015. This is the first MedDRA tool that allows users to select their preferred language for the User Interface from the 11 MedDRA languages. Other MVAT enhancements include data reports in all languages, improved term history display, the option to filter reports by primary System Organ Class (SOC), and improved reports for SMQ changes. 27th System Organ Class
The Board confirmed the implementation of a 27th SOC in March 2016 for MedDRA Version 19.0 which will be called Product issues. This new SOC will include terms relevant for issues with product quality, devices, manufacturing quality systems, product supply and distribution, and counterfeit products. A set of complex change proposals for the SOC Product issues will be posted for comments on the MedDRA website from July 2015 until September 2015. ICH M1 Points to Consider
The ICH M1 Points to Consider Working Group is planning to update the Points to Consider documents for MedDRA Version 19.0 to provide guidance to users and to reflect changes in MedDRA relating to the implementation of the new SOC Product issues. MSSO & JMO Continued Evolution
The Japanese Management Board reported on the Japanese Maintenance Organization’s (JMO) activities, and noted an increase in subscribers compared to the same period last year. The MSSO also reported on the growth of its subscriber base. Future areas of focus for the MSSO include supporting the global use of MedDRA, exploring interoperability between MedDRA and other medical terminologies, and investigating the use of new technologies for pharmacovigilance purposes. The next scheduled meeting of the Board will be on 5-6 December 2015 in Jacksonville, FL, USA. For further information, please contact the ICH Secretariat at admin@ich.org Download the PDF version of the Press Release

ICH Steering Committee, Lisbon, Portugal, November 2014

Tue, 02 Dec 2014 12:08:00 +0100

The International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) met in Lisbon, Portugal, EU on November 8-13, 2014. The meeting was hosted by the European Commission and included over 300 participants. The SC agreed on the key issues relating to the reform of ICH in terms of governance, new membership and funding. ICH remains committed to enhanced communication, transparency and the openness of ICH to all relevant stakeholders. The SC will now proceed with finalising the Articles of Association and funding model that will allow the ICH parties to carry out their internal consultations, which will pave the way towards establishing ICH as a legal entity as an international association under Swiss law. Membership in the Assembly, which will be the overarching body of the Association, will be established as soon as the legal entity has been set up. The SC had also organised a special session to inform interested parties on the state-of-play of the reform and to seek their views. All participants recognised the essential role of ICH in the development of internationally harmonised technical requirements for the registration of medicinal products and welcomed the objectives of the reform. They will be kept informed of ongoing developments. Safety Update
The SC adopted the Concept Paper on Nonclinical Safety Testing of Development of Paediatric Medicines (S11). This Guideline is needed to establish standards for the conditions under which nonclinical juvenile animal testing is considered informative and necessary to support paediatric clinical trials, and to provide guidance on the design of the studies. Efficacy Update
The EWG created to develop an Addendum to E6, Good Clinical Practices (GCP), made good progress towards a Step 2a document (expected in June 2015) considering innovative approaches to GCP. A new EWG on E9(R1) met to create an Addendum addressing the appropriate estimand in a clinical trial and the definition of the sensitivity analysis. The focus is to harmonise what “effect” a clinical trial should seek to estimate to avoid risk of inconsistent decision making. A newly created EWG met to address scientific and technical advances in paediatric drug development by developing an Addendum to E11. The Addendum will address methodological approaches, commonality of content in plans for pediatric drug development, ethical considerations, and age classification. It will also include high level consideration on extrapolation, modeling and simulation and paediatric formulations. The EWG developing the Guideline on Multi-Regional Clinical Trials (MRCTs) (E17) met for the first time and made progress on developing a Guideline which will promote appropriate conduct of MRCTs, resulting in further use of data from MRCTs in multiple regions and better regulatory decisions. The development of the E18 Guideline on Genomic Sampling Methodologies for Future Use began with the first meeting of the EWG. This Guideline will clarify points to consider in collecting Genomic samples in clinical trials. The E2B(R3) IWG has finalised its work on a Question & Answer (Q&A) document and updated the ICSR Implementation Guide package during the Lisbon meeting. The Q&A document, which includes 27 Q&As, was signed-off by the SC at Step 4. Work was also progressed on a revision of the CTD Efficacy Guideline by the recently established M4E(R2) EWG. The aim of the revision is to include greater specificity on the format and structure of benefit-risk information with the goal of harmonising the presentation of this information in regulatory submissions. Quality Update
The Q7 Implementation Working Group (IWG), Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, also met to continue its work on developing Q&As to address current issues raised by the use of the Q7 Guideline. The final set of 55 Q&As was agreed upon and will be sent out to obtain agreement from the constituencies regarding the final Q&A document prior to adoption and posting on the ICH website. A new EWG on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (Q12) met for the first time. The aim of the Guideline is to facilitate post-approval changes in a more predictable and efficient manner, promote innovation, managing quality and continual improvement throughout the lifecycle. The ICH SC approved the Concept Paper and Business Plan for the development of Q&As to Q11 for the purpose of clarifying the selection of starting materials for the manufacture of drug substances and what information should be provided in the marketing authorisation application or master files. An IWG will be formed to carry out this work. Electronic Standards
The M2 EWG (Electronic Standards for the Transfer of Regulatory Information) and the M8 EWG (The Electronic Common Technical Document - eCTD) met in Lisbon. MedDRA The ICH M1 Points to Consider Working Group met at EMA in London on November 10 – 12, 2014 to discuss refinements to the coding of medication errors considering the EU medication error project as well as off label use and other related concepts in MedDRA. The next ICH Steering Committee Meeting and its EWG meetings will be held in Fukuoka, Japan on June 6 – 11, 2015.

For further information, please contact the ICH Secretariat at admin@ich.org.

Download the PDF version of the Press Release

MedDRA Management Board, Lisbon, Portugal, November 2014

Tue, 18 Nov 2014 08:23:00 +0100

ICH MedDRA Management Board Endorses Blue Ribbon Panel Recommendation for a 27th SOC Lisbon, 9 November 2014 – The ICH MedDRA Management Board met in Lisbon, Portugal on 8-9 November 2014. 27th System Organ Class (SOC)
The Board endorsed the Blue Ribbon Panel’s recommendation for the addition of a 27th SOC in MedDRA to accommodate terms related to product quality concepts. The planned implementation date is March 2016 for MedDRA Version 19.0. The MSSO will engage in discussions with users regarding the details of this new SOC. MSSO Subscription Rates
The Board is pleased to announce that there will be no increase in MedDRA subscription rates for 2015. This is the result of continued growth of MedDRA subscribers throughout the world – currently numbering over 4,000 organisations – and increased efficiencies to contain costs of maintenance and development of the terminology. Special Licences
The Board received an update on the status of special licences granted to regulatory authorities which support low revenue organisations to use MedDRA for reporting requirements. There is now a total of over 1,000 organisations worldwide benefitting from special licences. Further information is available on the MedDRA website and is also referenced in a new MedDRA Factsheet – Accessing MedDRA. ICH M1 Points to Consider
The ICH M1 Points to Consider Working Group will be meeting at EMA in London on 10-12 November 2014 to discuss refinements to the coding of medication errors, off label use, and other related concepts in MedDRA, and to provide support to the EU medication errors project. Standardised MedDRA Queries (SMQs)
The Board acknowledged the significant efforts of the Council for the International Organization of Medical Sciences (CIOMS) SMQ Working Group and renewed the Memorandum of Understanding between ICH and CIOMS for a further year of development of new SMQs. The Board noted that there are now 96 SMQ topics in use. The next scheduled meeting of the Board will be on 6-7 June 2015 in Fukuoka, Japan. For further information, please contact the ICH Secretariat at admin@ich.org Download the PDF version of the Press Release

Bids Invited for MedDRA Maintenance & Support Services Contract

Fri, 15 Aug 2014 08:05:00 +0200

Geneva, August 15, 2014 – The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is conducting a Call for Tender for the MedDRA Maintenance and Support Services Organization (MSSO) contract. MedDRA, the Medical Dictionary for Regulatory Activities, is a standardised medical terminology developed to facilitate sharing of regulatory information internationally for human use medical products. It was first released in 1999. The maintenance and support of MedDRA is contracted to a MSSO. The tender is open from August 15 to October 31, 2014. Parties are encouraged to request the MSSO Tender Package by declaring their interest to mssotender@ich.org. The package (in English) will be available to suitably qualified parties on receipt of a signed confidentiality agreement (provided by ICH) and requested company information. Further information on this tender can be found on the ICH website www.ich.org/mssotender. Questions (in English) should be directed to mssotender@ich.org, c/o ICH Secretariat, Geneva, Switzerland. Download the PDF version of the Press Release

ICH Steering Committee, Minneapolis, MN, USA, June 2014

Tue, 08 Jul 2014 07:40:00 +0200

The International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) met in Minneapolis, MN, USA on May 31-June 5, 2014. The SC is pleased to announce the decision that Heath Canada (HC) and Swissmedic are now Steering Committee members. In recognition of their historical involvement and commitment to ICH, Health Canada and Swissmedic were invited to become Steering Committee members during the ICH meeting in Osaka, 2013. The invitation came as the SC continued its discussions around a future ICH construct. After further elaboration of the roles and responsibilities envisioned for HC and Swissmedic as SC members, the SC has determined that HC and Swissmedic are now ICH Steering Committee members under a governance model that has been evolving during the discussions on the future of ICH. As part of those discussions, a broader range of membership and governance reforms have been, and continue to be, considered, including the introduction of greater clarity regarding the distinct and separate roles of the ICH regulatory and industry parties in ICH. The ICH reform discussions have also been addressing parameters for creating a new legal entity for ICH and the future approach to funding. The roles of HC and Swissmedic as SC members conform to these governance principles. The Steering Committee further progressed the development of the five year ICH strategic plan for future ICH topics in order to improve the strategic oversight on ICH work. A Quality Workshop was organised on June 1, 2014 in Minneapolis, prior to the ICH meeting in order to discuss the strategic way forward and propose key Quality topics for the next 10 years. A list of five future Quality topics was subsequently proposed to the SC for future harmonisation. Safety Update
The M7 EWG on Assessment and Control of DNA Reactive (mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, reached agreement on the revised draft guideline satisfying all comments received during the public consultation and signed off at Step 4. The S5 Informal WG met to develop a Concept Paper, which was requested by the SC. Efficacy Update
A new EWG created to develop an Addendum to E6, Good Clinical Practices (GCP), met for the first time in Minneapolis and made good progress in developing recommendations to facilitate innovative approaches to GCP. They expect to reach Step 2 in June 2015. Quality Update
The Q3D EWG, Guideline for Elemental Impurities, met and plans to reach Step 4 in September 2014. The Q7 IWG, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, also met to continue their work on developing Q&As to address current issues raised by the use of the Q7 Guideline. The development of a Concept Paper for the new project on lifecycle management was endorsed by the SC considering the discussion at the workshop toward the next ICH meeting. Electronic Standards
The M2 (Electronic Standards for the Transfer of Regulatory Information) met in Minneapolis, as did the M8 EWG (The Electronic Common Technical Document- eCTD). M8 signed-off at Step 4 of Version 1.26 of the eCTD Change Request Q&A document and continued the development of the new ICH eCTD specification v4.0 (“Next Major Version”). MedDRA
In Minneapolis, ICH agreed the timeframe for the launch of a Call for Tender in mid-August for the contract for the MedDRA Maintenance and Support Services Organization (MSSO). ICH’s primary goal is to ensure that there is minimal impact for MedDRA users. Further tender details will be made available on the ICH website in July. The MedDRA Points to Consider Working Group updated two documents (Term Selection and Data Retrieval and Presentation) which should be completed and released with the new version of MedDRA on September 1, 2014. The next ICH Steering Committee Meeting and its EWG meetings will be held in Lisbon, Portugal on November 9-13, 2014. For further information, please contact the ICH Secretariat at admin@ich.org. Download the PDF version of the Press Release

MedDRA Management Board, Minneapolis, MN, USA, June 2014

Mon, 23 Jun 2014 00:00:00 +0200

ICH MedDRA Management Board Supports MedDRA’s Continuing Evolution Minneapolis, 1 June 2014 – The MedDRA Management Board met in Minneapolis, MN, USA on 31 May - 1 June 2014. Blue Ribbon Panel
On 29 April 2014, a MedDRA Blue Ribbon Panel met in Gaithersburg, MD, USA, to discuss whether the scope of MedDRA should be re-defined in its role as an international medical and regulatory terminology. In order to accommodate the evolving needs of the user community, possibility of expansion of the terminology into new requested topic areas was discussed. Questions including how to establish general criteria when considering potential areas for expansion (e.g., manufacturing product quality concepts) and where these can be placed in MedDRA were explored. The MedDRA Management Board considered the Panel’s recommendations and requested the MSSO to develop impact analyses, following which the Board will communicate its decisions to the MedDRA user community. ICH Points to Consider
The ICH M1 Points to Consider Working Group will be discussing refinements to the coding of medication errors in MedDRA and providing support to the EMA medication errors project. It was also noted that the Points to Consider documents in English and Japanese were released simultaneously with MedDRA Version 17.0 on 1 March 2014. Support for MedDRA Users
The MSSO reported on the development of software tools, including a new Web-based browser (WBB) which will replace the current Web-based browser by the end of 2014. The WBB will have a similar look and feel as the current MedDRA Desktop Browser and will add to the existing suite of tools which the Board has directed the MSSO to develop in support of MedDRA users. The MSSO will provide training to MedDRA users for the WBB in the form of webinars and videocasts. MSSO & JMO Continued Evolution
The Japanese Management Board reported on the Japanese Maintenance Organization’s (JMO) activities, and noted an increase in subscribers compared to the same period last year. The MSSO also reported on the growth of its subscriber base. Future areas of focus for the MSSO include supporting the global use of MedDRA and exploring interoperability between MedDRA and other medical terminologies used in the arena of patient safety. Special Session
The MedDRA Management Board welcomed representatives of Regional Harmonisation Initiatives and of Drug Regulatory Authorities/Department of Health to a special session on MedDRA. Presentations included regulators’ experiences with transitioning to MedDRA. MSSO Call for Tender
In Minneapolis, ICH agreed the timeframe for the launch of a Call for Tender in mid-August for the contract for the MedDRA MSSO. ICH’s primary goal is to ensure that there is minimal impact for MedDRA users. Further tender details will be made available on the ICH website in July. The next scheduled meeting of the Board will be on 8 - 9 November 2014 in Lisbon, Portugal. For further information, please contact the ICH Secretariat at admin@ich.org Download the PDF version of the Press Release

Invitation to Submit an Expression of Interest for the MSSO Tender

Mon, 10 Feb 2014 10:00:00 +0100

Geneva, February 10, 2014 – The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is considering a Call for Tender in 2014 for the contract for the MedDRA Maintenance and Support Services Organization (MSSO). In 1999, ICH released MedDRA, the Medical Dictionary for Regulatory Activities Terminology, as its standardised medical terminology. Since then, the maintenance and support of MedDRA has been contracted to a MSSO. ICH’s decision to now consider a Call for Tender represents interest to conform with good business practices and does not reflect on the performance of the current contractor. In order to acquire feedback on interest and approach, and to use the feedback to inform next steps, ICH is first conducting a Call for Expression of Interest. Full details, including instructions on the format and content of expressions of interest, can be found on the ICH website www.ich.org/eoi. Interested parties are invited to submit their expressions of interest by March 12, 2014. Responses written in English should be sent by both email and courier to the following coordinates and marked for the attention of the ICH Call for Tender Working Group: ICH Secretariat
Chemin Louis-Dunant 15
P.O Box 195
1211 Geneva 20
Switzerland
eoi@ich.org Download the PDF version of the Press Release

ICH Steering Committee, Osaka, Japan, November 2013

Mon, 02 Dec 2013 00:00:00 +0100

“ICH Reviews Future ICH Topics and Its Organisation Towards Increased Engagement Globally”

The International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) met in Osaka, Japan on 9 - 14 November 2013. The ICH SC furthered discussions on governance and increased engagement of regulators globally that had taken place in La Hulpe (Brussels) in June 2013. The SC agreed on organisational reform measures to foster international cooperation. In addition, the SC agreed to develop a 5-year plan for future ICH work and discussed potential new ICH topics to be further explored before the next meeting. With regard to ICH documents under development, further progress was made on the S10 Guideline on “Photosafety Evaluation” which reached Step 4 in Osaka.

Future ICH Topics

The ICH SC reviewed proposals for new topics provided by all parties and agreed on the development of concept papers for potential items such as providing further harmonisation on requirements for clinical trials. The SC will further discuss and prioritise potential new quality topics before the next face-to-face meeting. In order to improve the strategic oversight on ICH work, future topics will be integrated in a 5-year plan.

ICH Reform - Increased Engagement and Application of Guidelines Globally

The ICH SC continued its discussions on the reform of ICH. Principles for new rules of governance and membership were adopted that will allow regulatory authorities and industry global associations which apply ICH Guidelines, to be more involved in ICH activities. The ICH SC also exchanged views on new approaches for ensuring the resources to support ICH activities.

Multidisciplinary Update

The M8 Implementation Working Group (IWG) “Electronic Common Technical Document (eCTD)” has updated the current specification with progression to Step 4 of the V1.25 Question and Answer and Change Request document.

Efficacy Update

The ICH SC noted the work of E2C(R2) IWG that is working on a Q&A regarding the implementation and technical maintenance of the “Periodic Benefit-Risk Evaluation Report”, which reached Step 4 in May 2013. The E2C(R2) IWG aims to reach Step 4 of the Questions and Answers (Q&As) by the end of 2013.

Safety Update

The S10 EWG on “Photosafety Evaluation” reached Step 4 in Osaka. The Safety Brainstorming Session reviewed sixteen potential future topics and provided its recommendations to the ICH SC on priority topics. ICH agreed on the development of concept papers for priority topics.

Quality Update

The Annex 6 “Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions” to the Q4B Guideline reached Step 4. This harmonisation of pharmacopoeial texts in the three regions will reduce testing requirements for the industry. The Q7 IWG on “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients” met for the third time to develop a Q&A document to address current issues raised by the use of the Q7 Guideline. Its work focused on the development of Q&As based on the survey conducted in late 2012.

MedDRA

In 1999, ICH released MedDRA as its standardised medical terminology. The maintenance and support of MedDRA is contracted to a Maintenance and Support Services Organisation (MSSO). ICH has decided that a new Call for Tender should be undertaken. This decision represents the interest of the ICH to conform with good business practices and does not reflect on the performance of the current contractor. ICH will publish a Request for Information/Call for Expression of Interest in early 2014, in order to identify interest from potential service providers. Next meeting The next meeting of the ICH Steering Committee, its Expert Working Groups and Implementation Working Groups, will be held in Minneapolis, MN, USA on 31 May - 5 June 2014. For further information, please contact the ICH Secretariat at admin@ich.org. Download the PDF version of the Press Release

MedDRA Management Board, Osaka, Japan, November 2013

Mon, 02 Dec 2013 17:07:00 +0100

ICH MedDRA Management Board Supports MedDRA’s Continued Evolution and High Quality Maintenance

Osaka, 10 November 2013 – The ICH MedDRA Management Board met in Osaka, Japan on 9-10 November 2013.

ISO Certification

The Japanese Management Board reported on the Japanese Maintenance Organization’s (JMO) activities, and noted an increase in pharmaceutical company subscribers compared to the same period last year. The ICH MedDRA Management Board congratulated the JMO on receiving its first ISO 9001 certification in 2013. It was also noted that the MedDRA Maintenance and Support Services Organization (MSSO) had retained its ISO certification following successful completion of an annual audit.

2014 MSSO Subscription Rates

Starting in 2014, the MSSO will introduce a new subscription level, Commercial 6, for organisations with annual revenue (or turnover) of $20 billion USD or more. In the past few years, several large organisations have merged and this has caused the MSSO and the ICH MedDRA Management Board to implement a change in the subscription structure, designed to rebalance the cost to the upper end of the range of subscription levels. Prices for the existing levels (Non-Commercial/Non-Profit, Commercial 0-5, and Developer) levels have not increased over the last nine years.

Organisation of a Blue Ribbon Panel

A MedDRA Blue Ribbon Panel will meet in the USA in the first half of 2014 to address the scope of MedDRA as a medical and regulatory terminology and how it may evolve to meet the needs of its users. Topics to be discussed in relation to a potential expansion of the scope of MedDRA include the addition of manufacturing product quality terms and the further support of device related terms.

MedDRA Special Session

The ICH MedDRA Management Board welcomed to a special session in Osaka representatives of Regional Harmonisation Initiatives and of Drug Regulatory Authorities/Department of Health interested in MedDRA. During this session, presentations included transitioning to and accessing MedDRA, the development and maintenance of translations, and an overview of the evolution and scope of the terminology.

ICH Decision to Undertake a New Call for Tender

In 1999, ICH released MedDRA as its standardised medical terminology. The maintenance and support of MedDRA is contracted to a MSSO. ICH has decided that a new Call for Tender should be undertaken. This decision represents the interest of the ICH to conform with good business practices and does not reflect on the performance of the current contractor. ICH will publish a Request for Information/Call for Expression of Interest in early 2014, in order to identify interest from potential service providers. The next scheduled meeting of the Board will be on 31 May - 1 June 2014 in Minneapolis, MN, USA. For further information, please contact the ICH Secretariat at admin@ich.org. Download the PDF version of the Press Release

ICH Steering Committee, La Hulpe, Belgium, June 2013

Sat, 08 Jun 2013 00:00:00 +0200

“ICH Pursues its Reform and Takes Steps Towards Increased Transparency”

The International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) met in La Hulpe, Belgium on 1 - 6 June 2013. Furthering the discussions on structural changes and increased engagement of regulators globally that took place in San Diego in November 2012, the ICH SC agreed measures aimed at increased transparency – a step forward in fostering openness as ICH continues its pursuit of greater harmonisation. Further progress was made on the individual topics, notably the Q3D on “Elemental Impurities” which reached Step 2a/2b in Brussels. Towards Increased Transparency The ICH SC has agreed to make more detailed information regarding the ongoing ICH activities available to the public. From now on, the agenda and the report of the SC meetings as well as the work plans of active expert working groups will be published on the ICH website. The ICH procedures and a set of slides summarising their key elements will also be published. The ICH website will be updated to reflect these changes. ICH Reform - Increased Engagement and Implementation of Guidelines Globally The ICH SC made progress in the discussions on further reform of ICH. A new ICH organisational structure will be adopted and will set the framework for new rules on governance, decision making and membership. To promote greater involvement of global regulators, the ICH Global Cooperation Group (GCG) was successfully integrated into sessions of the ICH Steering Committee. Electronic Standards The ICH SC endorsed an extended mandate of an E2B(R3) Implementation Working Group (IWG) on the implementation and technical maintenance of the “Electronic Transmission of Individual Case Safety Reports (ICSR)” based on the Implementation Guide (IG), which progressed to Step 4 in November 2012. This is to incorporate the use of the five international ISO standards on Identification of Medicinal Products (IDMP) constrained for the purpose of ICSR reporting on the basis of E2B(R3). These IDMP ISO standards are the second work item to be successfully completed under a pilot process with Standards Development Organisations and result from the activities of the ICH M5 “Data Elements and Standards for Drug Dictionaries” Expert Working Group. The SC expressed its appreciation to the M5 group for these achievements and consequently decided to disband the group. Further IDMP implementation work focusing on the life cycle management of medicinal products will be progressed by interested regulators outside of the ICH framework. Safety Update The S10 EWG on “Photosafety Evaluation” reviewed the outcome of the public consultation in view of finalising the guideline. The S1 EWG on “Rodent Carcinogenicity Studies for Human Pharmaceuticals” went through comments received on the draft Regulatory Notices Document (RND). The initiative to discuss the strategy for testing the carcinogenic potential received a broad support by all the stakeholders that commented on the RND. Quality Update The Q3D EWG on “Elemental Impurities” reached Step 2a/2b in Brussels. This draft guideline contains 3 elements: the evaluation of the toxicity data for potential elemental impurities, the establishment of a Permitted Daily Exposure (PDE) for each element of toxicological concern, and development of controls designed to limit the inclusion of elemental impurities in drug products to levels at or below the PDE. The draft guidance will be released for public consultations. The Q7 IWG on “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients” met for the second time in view of developing a Q&A document to address current issues raised by the use of the Q7 Guideline. This work is carried out in collaboration with the Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Cooperation Scheme (jointly referred to as PIC/S). The next ICH Steering Committee and its Expert Working Groups meetings will be held in Osaka, Japan on 9 - 14 November 2013. For further information, please contact the ICH Secretariat at admin@ich.org. Download the PDF version of the Press Release

MedDRA Management Board, La Hulpe, Belgium, June 2013

Mon, 03 Jun 2013 00:00:00 +0200

MedDRA Management Board Continues to Facilitate Further Global Uptake of MedDRA

La Hulpe, 2 June 2013 – The MedDRA Management Board met in La Hulpe, Belgium on 1 - 2 June 2013. The MedDRA Management Board welcomed to a special session representatives of Regional Harmonisation Initiatives and of Drug Regulatory Authorities/Departement of Health interested in MedDRA. During this session, presentations included MedDRA as a multi-axial terminology, facilitating the use of MedDRA, and best practices for using the terminology. In addition, a representative of China’s ICH Research M Group – a working group that studies the “M” ICH initiatives – provided an update on their activities. The Japanese Management Board (JMB) reported on the activities of the Japanese Maintenance Organization (JMO). The JMO has started to provide MedDRA in European languages to their subscribers for no additional fee. The JMB also noted an increase in JMO Web-academia subscribers. It was noted that the JMO expects to receive their ISO certification of the JMO’s MedDRA maintenance processes in June 2013. The ICH Secretariat reported on a meeting held in March 2013 in Beijing, China. The meeting was attended by members of the China Food and Drug Administration, the Chinese Pharmacopoeia, members of the ICH Research M Group, representatives of the Chinese industry, and ICH representatives. Presentations were given by ICH regulatory authorities regarding the use of MedDRA in their regions. Additional topics included the Chinese translation of MedDRA and the feasibility of implementing MedDRA in China. The MSSO reported that they trained over 1400 MedDRA users in 2012. This included training sessions hosted by regulatory authorities in Germany, Canada, Turkey and China, and by the European Medicines Agency. The MSSO also posted on their website several new training videocasts that can be freely downloaded or streamed. These videocasts are short presentations on focused topics such as the scope and structure of MedDRA and Standardised MedDRA Queries (SMQs). The next scheduled meeting of the Board will be on 9 - 10 November 2013 in Osaka, Japan. For further information, please contact the ICH Secretariat at admin@ich.org. Download the PDF version of the Press Release

ICH Steering Committee, San Diego, CA, USA, 14-15 November 2012

Thu, 22 Nov 2012 11:43:00 +0100

“ICH makes progress on ongoing reform and adopts Guidelines for safety reporting”

The International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) met in San Diego, California, USA on November 10-15, 2012. Building on the new principles of governance defined in Fukuoka, Japan in June 2012, the ICH SC approved procedural changes that reflect these principles. The ICH SC discussed further reform aimed at increasing the engagement of regulators globally and reiterated its commitment to the importance of harmonisation. Further progress was made on the individual topics, notably the safety reporting Guidelines E2B(R3) and E2C(R2) reached Step 4.

Ongoing ICH Reform: Procedural Changes and Increased Engagement

The ICH SC has finalised procedural changes implementing the agreed new principles of governance which better define the roles of regulator and industry parties within ICH that were established in Fukuoka. In addition, the ICH SC is looking into further reforms of ICH that will increase efficiency of the process and solicit greater engagement of global regulators. For this purpose, all partners are identifying structural changes to the GCG to serve as a better platform for dialogue. The ICH SC also seeks to implement a training strategy building on innovative ways to deliver training materials on core ICH topics. In addition, the ICH SC is defining a new proactive approach to identify and creatively pursue advancements in science which can be utilised to take up potential new topics for harmonisation and/or revise existing Guidelines to reflect the current state of the art. In this context, two new groups have been established to address evolving science in the areas of quality and non-clinical drug development.

Electronic Standards

The E2B(R3) Expert Working Group (EWG) on revision of the “Electronic Transmission of Individual Case Safety Reports (ICSR)” progressed its Implementation Guide (IG) to Step 4. It is the first ICH work item to be completed under a pilot process that involved work in parallel with standards development organisations. The ICH SC endorsed the establishment of an E2B(R3) Implementation Working Group (IWG) to facilitate implementation and technical maintenance. Reflecting its joint work activities with international standards data organisations, the M5 “Data Elements and Standards for Drug Dictionaries” EWG reported on the progression towards Step 2 of the related ICH Implementation Guide. The M8 “Electronic Common Technical Document (eCTD)” EWG progressed its testing on the next major version of the eCTD (v.4.0).

Safety Update

The S10 EWG on “Photosafety Evaluation” reached Step 2 and a draft Guideline will be soon released in each region for public consultation. S1 EWG on “Rodent Carcinogenicity Studies for Human Pharmaceuticals” drafted a consensus Regulatory Notice Document (RND) and Draft Appendix of Weight-of-Evidence (WoE) approach to be published by the regulatory authority in each ICH region. The notice will request public input to a proposed change in the approach to carcinogenicity assessment, on the prospective evaluation period intended to test a new approach, and on the WoE elements proposed for inclusion in carcinogenicity assessment documents. M7 EWG on “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” met in San Diego and will reach Step 2 in the coming month via postal sign-off.

Efficacy Update

The E2C(R2), Periodic Benefit-Risk Evaluation Report (PBRER) EWG reached Step 4. This revision of E2C will introduce a new periodic benefit-risk evaluation report, which represents a change in focus from individual case reports to more aggregate data evaluation. Thanks to the commitment of all ICH parties, this major revision was accomplished in less than 2 years. The ICH SC endorsed the establishment of an E2C(R2) IWG to facilitate implementation.

Quality Update

The Q7 “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients” IWG met for the first time in San Diego to start the process of drafting a Q&A document to address current issues raised by the use of the Q7 Guideline, and the Q3D “Metal Impurities” EWG made good progress in defining safety assessments, risk assessments and control strategies for addressing potential metal impurities. The next ICH Steering Committee and its Expert Working Groups meetings will be held in Brussels, Belgium on June 1-6, 2013. For further information, please contact the ICH Secretariat at admin@ich.org. Download the PDF version of the Press Release

MedDRA Management Board, San Diego, CA, USA, 10-11 November 2012

Sun, 11 Nov 2012 00:00:00 +0100

For Eighth Year in a Row, No Increase in MedDRA Subscription Rates San Diego, 11 November 2012 – The MedDRA Management Board met in San Diego, CA, USA on 10 – 11 November 2012. The Board is pleased to announce that, for the eighth year in a row, there will be no increase in MedDRA subscription rates for 2013. This is the result of continued growth of MedDRA subscribers throughout the world and increased efficiencies to contain costs of maintenance and development of the terminology. For the sixth time, the MedDRA Management Board welcomed the Regional Harmonisation Initiative and Drug Regulatory Authority/Department of Health members of the ICH Global Cooperation Group to a special session. During this special session, the Board and the invited guests heard from representatives of various regulatory authorities who described their experiences with the implementation of MedDRA and the use of MedDRA for data analysis. The Board renewed the Memorandum of Understanding between ICH and the Council for the International Organization of Medical Sciences (CIOMS) for a further year of development of new Standardised MedDRA Queries (SMQs). The Board noted that there are now 87 SMQ topics in production. The Japanese Management Board (JMB) reported on the activities of the Japanese Maintenance Organisation (JMO). The JMB reported that JMO is improving services to MedDRA/J users such as enhancement of user training. The JMB also noted participation of a substantial number of subscribers in every Explanatory Meeting for new MedDRA versions which shows a high interest among subscribers in the updated MedDRA versions. The MSSO reported on its participation in ICH training on “M” initiatives (including MedDRA) held in Beijing, China in October 2012. There was keen interest in the ICH initiatives by the attendees. The MSSO reported that it is developing a series of short training videocasts on MedDRA topics. The videocasts are produced in multiple languages, and some topics are already available. The videocasts can be accessed on the MSSO Web site and on YouTube. The next meeting of the Board will be on 1-2 June 2013 in La Hulpe, Belgium. For further information, please contact the ICH Secretariat at admin@ich.org. Download the PDF version of the Press Release

ICH Steering Committee, Fukuoka, Japan, 6-7 June 2012

Tue, 03 Jul 2012 23:18:00 +0200

“ICH Parties Agree on New Principles of Governance”

The International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) met in Fukuoka, Japan on June 2-7, 2012. Building on 20 years of successful collaboration towards achieving greater international harmonisation for pharmaceutical products registration, the ICH parties agreed on new principles of governance for robust science-based Guidelines for the review of the safety, efficacy, and quality of medicinal products. In addition, ICH confirmed its commitment to strengthen its global outreach. Further progress was made on the individual topics, notably the Electronic Common Technical Document (eCTD) (ICH M8). New Principles of Governance
The six official ICH parties have agreed on new principles of governance which better define the roles of regulator and industry parties within ICH. This action will highlight ICH’s longstanding premise that the regulators have the ultimate responsibility in ensuring the protection of public health, in addition to their competence to issue regulatory Guidelines. ICH will continue to be consensus driven, and strive to remain at the cutting-edge of scientific and technical developments in the pharmaceutical area. This will require the continued close cooperation between regulatory and pharmaceutical industry experts that has been instrumental in providing the best scientific and technical input in the development of ICH products, but with some changes. In the future, EWGs will be chaired by a representative of the regulators who will be responsible for ensuring regulatory oversight as well as integrity of the entire process. In addition, the current four step ICH procedure for work products will be reviewed to provide a clear distinction between the collation of scientific and technical information into a "technical document" by the experts, and the development of this document into a regulatory ICH Guideline by the regulators. In circumstances when regulators and industry may not have the same interests or priorities with respect to a particular harmonisation activity the new principles allow ICH to proceed with a proposed topic for harmonisation provided it is supported by the three ICH regulatory parties, irrespective of whether or not this topic is supported by the industry parties. The current Step 3 procedures of public consultation within the three regulatory parties, as well as through ICH, Observers and WHO contact points, will be maintained. Transparency will be further increased through the publication of information about the ICH process on the ICH website, including publication of "technical documents." These principles will be incorporated into revised Rules of Procedures which are due to be adopted at the next meeting of the ICH Steering Committee. Global Outreach Activities
The ICH Steering Committee and the Global Cooperation Group (GCG)¹ welcomed an increased commitment from the Regional Harmonisation Initiatives (RHIs) and Drug Regulatory Authorities that constitute the GCG. The regulators from beyond the original three ICH regions and the RHIs voiced strong support for regular dialogue amongst themselves and to further contribute to the GCG and related activities. Multidisciplinary Update
The M8 EWG/IWG “Electronic Common Technical Document (eCTD)” has progressed the eCTD v4.0 Draft Implementation Guide (IG) to the feasibility testing towards Step 2. During this period, the usability of the Draft IG along with technical feasibility of HL7 Regulated Product Submissions (RPS) standard to the ICH requirements will be tested. The M8 IWG has released the updated Q&A on the current eCTD specifications which gives further guidance on organization of CTD Module 3 documents by XML attributes. Safety Update
The S1 EWG “Rodent Carcinogenicity Studies for Human Pharmaceuticals” met for the first time. This working group will clarify the criteria used to determine, without compromising safety, the necessity of two-year rodent carcinogenicity studies to address the risk of human carcinogenicity in pharmaceuticals under development. Efficacy Update
The Q&As on the E3 Guideline “Structure and Content of Clinical Study Reports (CSR)” reached Step 4. This document clarifies several important aspects in documenting the CSRs, including flexibility in the structure, requirements for appendices, and terminologies used in the E3 Guideline. Quality Update
The Annex 13 “Bulk Density and Tapped Density of Powders General Chapter” to the Q4B Guideline reached Step 4. This harmonisation of pharmacopoeial texts in the three regions will reduce testing requirements for the industry. FAQs on the Q4B concept and activities will also be available on the ICH website. The next ICH Steering Committee and its expert working groups meetings will be held in San Diego, California, USA, on November 10-15, 2012. For further information, please contact:
ICH Secretariat
Chemin Louis-Dunant, 15
P.O Box 195, 1211 Geneva 20
Switzerland
Tel: +41 22 338 3206 - Fax: +41 22 338 3230
E-mail: admin@ich.org - Web site: www.ich.org ¹The ICH Global Cooperation Group is a subgroup of the ICH Steering Committee and is composed of one representative from each of the six parties on the ICH Steering Committee, plus three Observers (WHO, Health Canada and EFTA) and IFPMA are also part of the GCG. Regional Harmonisation Initiatives, namely APEC, ASEAN, EAC, GCC, PANDRH and SADC, as well as Drug Regulatory Authorities and Departments of Health from Australia, Brazil, China, Chinese Taipei, India, Republic of Korea, Russia and Singapore have also been invited to designate permanent representatives to the GCG. Download the PDF version of the press release

MedDRA Management Board, Fukuoka, Japan, 2-3 June 2012

Mon, 04 Jun 2012 01:00:00 +0200

The Management Board Welcomes the Recent Launch of the MedDRA Version Analysis Tool

Fukuoka, 3 June 2012 – The MedDRA Management Board met in Fukuoka, Japan on 2 - 3 June 2012. The MSSO provided data on user uptake of the new MedDRA Version Analysis Tool (MVAT). MVAT assists users in understanding the differences between any two versions of MedDRA. Over 150 organisations have used MVAT since its launch in February 2012. For the fifth time, the MedDRA Management Board welcomed the Regional Harmonisation Initiative and Drug Regulatory Authority/Department of Health members of the ICH Global Cooperation Group to a special session. During this special session, the Board heard from representatives of various regulatory authorities who described their experiences of implementing MedDRA in their pharmacovigilance systems, including interoperability considerations (i.e., links between MedDRA and other standard terminologies) and use of MedDRA for medication error reporting. The Japanese Management Board (JMB) reported on the activities of the Japanese Maintenance Organisation (JMO). The JMB reported that the number of JMO subscribers has grown mainly due to increased numbers of web-type subscribers from academia. The Board authorised the MSSO to make changes to neoplasm terms in MedDRA (new terms and revised placement of existing terms) based on a 2011 Blue Ribbon Panel. The aim is increased histologic specificity in MedDRA to improve coding and analysis of oncology data. These changes will begin in MedDRA Version 16.0 (March 2013). The MSSO informed the Board that an upgraded version of the MedDRA Desktop Browser will be available this summer to MedDRA users. The browser will have several enhancements such as synonym lists and display of the history of terms in all MedDRA languages, and an ability to have a network distribution. The UK Medicines and Healthcare products Regulatory Agency (MHRA) described a recently launched project to map a subset of SNOMED-CT© terms to MedDRA. This will facilitate the MHRA’s integration of adverse reaction data from electronic health records in the UK, currently coded with SNOMED-CT©, into their MedDRA-coded data collected from their eYellow Card system. The next meeting of the Board will be on 10–11 November 2012 in San Diego, USA. For further information, please contact:
ICH Secretariat, Chemin Louis-Dunant, 15, P.O Box 195, 1211 Geneva 20, Switzerland. Tel: +41 22 338 3206, fax: +41 22 338 3230, e-mail: admin@ich.org, website: www.ich.org Download the PDF version of the press release

ICH Steering Committee, Seville, Spain, 9-10 November 2011

Thu, 10 Nov 2011 01:00:00 +0100

“International Harmonisation Reaches Milestone on Preclinical Safety”

The International Conference on Harmonisation (ICH) Steering Committee (SC) and its working groups met in Seville, Spain from 5 - 10 November 2011. Safety Update
Following an extended consultation period, the SC approved a revised ICH S2(R1) Guideline for genotoxicity testing and data interpretation for medicines intended for human use. This revised Guideline reflects state of the art options for genotoxicity testing and is expected to improve risk assessment of human medicines. It is also expected to reduce the number of animals used for genotoxicity testing alone in the implementing regions and thus to enhance the efficiency and use of resources in the development of medicines. Quality Update
The Quality Implementation Working Group (IWG) completed three documents on points to consider on ‘Process validation/ Process verification’, ‘Role of Modelling in Quality by Design’ and ‘Design Space’. Combined with previously finalised question-and-answer-documents (Q&As) and training material these documents provide a complete set of guidance to manufacturing of pharmaceuticals in the twenty first century. Global Outreach Activities
Having opened in 2010 quality, safety and efficacy expert working groups (EWGs) to experts from non-ICH regions, representatives from Chinese Taipei, Korea and Singapore regulatory authorities participated to the activities of EWGs on Genotoxic Impurities (M7), Metal Impurities (Q3D), Periodic Benefit Risk Evaluation Report (E2C), Photosafety (S10) and Development and Manufacture of Drug Substances (Q11). The ICH Global Cooperation Group welcomed for the first time representatives of the East African Community (EAC), a regional harmonisation initiative composed of Burundi, Kenya, Rwanda, Tanzania and Uganda. Telematics
The EWG working on the Electronic Common Technical Document, eCTD (ICH M8) released an updated Q&A document. This update clarifies which PDF versions are acceptable in all regions and advises how to organise excipient information within the eCTD. Notes
1. The S2(R1) Guideline merges the original two ICH S2A (dated 1995) and S2B (dated 1997) Guidelines into one.
2. All documents adopted at this SC meeting will be published on the ICH website shortly.
3. The ICH Global Cooperation Group is a subgroup of the ICH Steering Committee and is composed of one representative from each of the six parties on the ICH Steering Committee, plus three Observers (WHO, Health Canada and EFTA) and IFPMA are also part of the GCG. Regional Harmonisation Initiatives, namely APEC, ASEAN, EAC, GCC, PANDRH and SADC, as well as Drug Regulatory Authorities and Departments of Health from Australia, Brazil, China, Chinese Taipei, India, Republic of Korea, Russia and Singapore have also been invited to designate permanent representatives to the GCG.
4. More information on the work of the ICH can be found on its website: www.ich.org
5. The next meeting of the ICH Steering Committee and its expert working groups will be held in Fukuoka, Japan from 2 - 7 June 2012. For further information, please contact:
ICH Secretariat
Chemin Louis-Dunant, 15, P.O Box 195
1211 Geneva 20, Switzerland
Tel: +41 22 338 3206 E-mail: admin@ich.org
Fax: +41 22 338 3230 Website: www.ich.org Download the PDF version of the press release

MedDRA Management Board, Seville, Spain, 5-6 November 2011

Sun, 06 Nov 2011 01:00:00 +0100

The Management Board Further Enhances the Use of MedDRA

Seville, 6 November 2011 – The MedDRA Management Board met in Seville, Spain on 5 - 6 November 2011. The MedDRA Management Board is pleased to announce that the 2012 MSSO MedDRA subscription fees will remain the same as 2011. This is the 7th consecutive year that the subscription rates have not increased. This was the fourth time the MedDRA Management Board hosted an open session to welcome the Regional Harmonisation Initiative and Drug Regulatory Authorities/Departments of Health members of the ICH Global Cooperation Group (GCG). Regulatory representatives of ICH and non-ICH regions shared their perspectives on the use of MedDRA in regulatory reporting and pharmacovigilance processes. Austrialian TGA, EMA, UK MHRA, and US FDA were among the presenters. Further to training conducted in China, Panama and Singapore in 2011, the Board continues to work closely with ICH GCG members to support requests for training beyond ICH regions. The Board recognizes and supports the ongoing valuable work of Council for International Organizations of Medical Sciences (CIOMS) SMQ Working Group. In addition to developing new SMQs, there will be an update to the CIOMS “Development and Rational Use of Standardised MedDRA Queries (SMQs)” publication that will provide guidance on the use and implementation of SMQs. The MedDRA Version Analysis Tool (MVAT) is scheduled to be released to users in the first quarter of 2012. This new tool is part of an evolving suite of software applications, such as the Desktop Browser and Web-Based Browser, that facilitates the use of MedDRA. MVAT will enhance the user’s ability to easily compare any two versions of MedDRA. The Japanese Management Board (JMB) reported on the activities of the Japanese Maintenance Organization (JMO). They noted that there is growth in the number of JMO subscribers due to increased use by academics. The Board acknowledged that the Seville meeting would be the final meeting of long-standing Board member Mr. Morell David who will leave shortly his position at the UK MHRA. The Board expressed its sincere appreciation for Mr. David’s significant contribution to the MedDRA project over the years. The next scheduled meeting of the Board will be on 2 - 3 June 2012 in Fukuoka, Japan. For further information, please contact:
ICH Secretariat, c/o IFPMA, Chemin Louis-Dunant, 15, P.O Box 195, 1211 Geneva 20, Switzerland. Tel: +41 22 338 3206, fax: +41 22 338 3230, e-mail: admin@ich.org, website: www.ich.org Download the PDF version of the press release

ICH Steering Committee, Cincinnati, OH, US, 15-16 June 2011

Sat, 18 Jun 2011 09:09:00 +0200

“ICH Global Expansion – Enhanced Scientific Exchanges”

The International Conference on Harmonisation (ICH) Steering Committee (SC) and its working groups met in Cincinnati, Ohio from June 11-16, 2011. Global Outreach Activities
For the first time, non-ICH regulators have been nominated to serve as experts in some quality, safety and efficacy expert working groups (EWGs). ICH welcomed the active participation of technical experts from China, Chinese Taipei, Korea and Singapore. In efforts to further the global reach of ICH, the Global Cooperation Group (GCG) accepted the request of the East African Community (EAC) to join the other Regional Harmonization Initiatives in the GCG dialogue. The EAC is comprised of five countries: Kenya, Uganda, Tanzania, Rwanda and Burundi. In recent years, the EAC’s work on harmonization of medicines regulation has increased, and with the support of the World Health Organization, they have moved towards implementing many ICH guidelines, including the ICH Common Technical Document (CTD). A group of global regulators who are cooperating in the area of cell therapy updated the ICH Steering Committee on their activities and reported that they are exploring potential areas for future harmonization or other approaches to regulatory convergence. Quality Update
The Q11 draft Guideline, “Development and Manufacture of Drug Substances,” reached Step 2. This guideline describes approaches to developing process and drug substance understanding and also provides guidance on what information should be provided in a CTD. It provides further clarification on the principles and concepts described in ICH guidelines on Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality Systems (Q10) as they pertain to the development and manufacture of drug substance. The Quality Implementation Working Group (IWG) completed three ‘Points to Consider’ documents on “Criticality of Quality Attributes and Process Parameters,” “Control Strategy,” and “Level of Documentation in Enhanced (QbD) Regulatory Submissions.” These documents will serve to provide supplementary information to the previously completed Q&A’s and training materials. Safety Update
The S6(R1) EWG reached Step 4 on the Addendum to the S6 Guideline “Revision of Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals.” The purpose of the addendum is to provide clarification of language in the original ICH S6 document regarding species selection, study design, immunogenicity, reproductive and developmental toxicity and carcinogenicity testing. The Addendum will be integrated in the core S6 Guideline which will be renamed S6(R1). The M3(R2) IWG, “Guidance on Non-clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals” finalized three sets of questions and answers at Step 4 which address limit dose, reversibility of toxicity, and metabolites. Efficacy Update
The E2B(R3) EWG “Revision of the Electronic Submission in Individual Case Safety Reports” progressed the E2B(R3) Implementation Guide (IG) to Step 2. This marks a significant milestone in that it is the first ICH work item to reach Step 2 under a pilot process that involved work in parallel with standards development organizations. The next ICH Steering Committee meeting and its expert working groups will be held in Sevilla, Spain from November 5 – 10, 2011. For further information, please contact:
ICH Secretariat, c/o IFPMA
Chemin Louis-Dunant, 15, P.O Box 195
1211 Geneva 20, Switzerland
Tel: +41 22 338 3206
E-mail: admin@ich.org - Fax: +41 22 338 3230
Web site: www.ich.org Download the PDF version of the press release

MedDRA Management Board, Cincinnati, OH, US, 11-12 June 2011

Sun, 12 Jun 2011 01:00:00 +0200

The MedDRA Management Board Congratulates CIOMS Working Group on SMQs for its Important Contribution to Public Health Protection

Cincinnati, 12 June 2011 – The MedDRA Management Board met in Cincinnati, Ohio, USA on 11-12 June 2011. The MedDRA Management Board welcomed news of the completion of the current phase of development work on Standardized MedDRA Queries (SMQs) by the CIOMS Working Group on this topic. The Board noted that by the time of the release of MedDRA 15.0 in March 2012 a total of 90 SMQs will be available to MedDRA users. The Board conveyed its congratulations to the Working Group for this significant achievement and recognized the benefit of these important signal detection tools for the protection of public health. Members of the ICH Global Cooperation Group from beyond the ICH regions were invited to a special session of the Board. Regulatory and industry representatives on the Board provided their perspectives on the benefits of using MedDRA in clinical trials. Presentations were also given by representatives from the Singapore Health Sciences Authority (HSA) and the Chinese State Food and Drug Administration (SFDA). The Singapore representative reported on their experiences in implementing MedDRA and gave the Board positive feedback on recent ICH-sponsored training in their country. The Board reviewed results of a survey of users of the MedDRA Web-based Browser. Over 300 MedDRA users responded to the survey. The Board noted the high-level of satisfaction with the browser and that additional specific input from responders will be used to continue to improve the tool. The Board was pleased to hear the progress made to date on the development of the MedDRA Version Analysis Tool. The MSSO expects the tool to be available late 2011. The Japanese Management Board (JMB) reported on the activities of the Japanese Maintenance Organization (JMO). They noted that a substantial number of subscribers in Japan participate in the “explanatory meetings” that the JMO holds after each release of MedDRA, reflecting a continued high interest among subscribers in changes to MedDRA. The next scheduled meeting of the Board will be on 5-6 November 2011 in Seville, Spain. For further information, please contact: ICH Secretariat, c/o IFPMA, Chemin Louis-Dunant, 15, P.O Box 195, 1211 Geneva 20, Switzerland Tel: +41 22 338 3206 Fax: +41 22 338 3230 E-mail: admin@ich.org - Web site: www.ich.org Download the PDF version of the press release

ICH Steering Committee, Fukuoka, Japan, 10-11 November 2010

Thu, 11 Nov 2010 00:00:00 +0100

ICH Looks Ahead to the Next Decade: Further Expansion to Non-ICH Regions

The International Conference on Harmonisation (ICH) Steering Committee (SC) and its working groups met in Fukuoka, Japan from 6 - 11 November 2010. This meeting marked the 20 year anniversary of this highly successful international harmonization initiative.

Further Opening to Non-ICH Regions

The ICH SC endorsed the opening of the ICH technical working groups to the active participation of experts from qualifying members of the Global Cooperation Group (GCG). This represents a new level of involvement of the GCG and will provide an opportunity for direct technical contributions to the work of ICH, a more global perspective, and will advance implementation of ICH guidelines.

Celebration of the 20th Anniversary

ICH published a brochure entitled “The Value & Benefits of ICH to Drug Regulatory Authorities-Advancing Harmonisation for Public Health” in recognition of its 20th anniversary. This publication salutes two decades of the ICH’s groundbreaking work in harmonising drug regulatory requirements among global partners. A copy of the article is available on the ICH website.

Pharmacovigilance

A pharmacovigilance brainstorming session was held for an overarching discussion on safety update reporting in view of Development Safety Update Report (DSUR) and Periodic Safety Update Report (PSUR) as well as benefit/risk approaches and current legislative parameters and regional constraints. The participants developed a shared vision of pharmacovigilance aimed at optimising the lifecycle benefit/risk of medicines for the promotion and protection of public health. Further discussion will continue within the ICH framework.

Quality

Progress was made on the harmonisation of pharmacopoeial texts. The Annex 7(R2) on Dissolution Test for the ICH Q4B Guideline (Evaluation and Recommendation of Pharmacopoeial Text for Use in the ICH Regions) reached Step 4. The three regional training workshops on the ICH Q8, Q9 and Q10 guidelines led by the ICH Quality Implementation Working Group (IWG) were well-attended and considered successful by both regulatory and industry participants. The IWG will proceed to address remaining technical /regulatory gaps identified through the workshops.

Safety

To facilitate further harmonisation, two new Expert Working Groups launched discussions on the ICH Guidelines M7 (Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk) and S10 (Photosafety Evaluation). In these initial meetings, productive discussions were held, and significant progress was made. The next ICH Steering Committee and its expert working groups meetings will be held in Cincinnati, Ohio, USA from 11-16 June 2011.

For further information, please contact:

ICH Secretariat, c/o IFPMA, Chemin Louis-Dunant, 15, P.O Box 195, 1211 Geneva 20, Switzerland. Tel: +41 22 338 3206 E-mail: admin@ich.org
Fax: +41 22 338 3230 Web site: www.ich.org

[1] The GCG currently includes representatives from Australia, Brazil, China, Chinese Taipei, India, Russia, South Korea and Singapore, and other harmonisation initiatives, such as Asia-Pacific Economic Cooperation (APEC), Association of Southeast Asian Nations (ASEAN), Gulf Cooperation Countries (GCC), Pan American Network on Drug Regulatory Harmonization (PANDRH) and Southern African Development Community (SADC).

MedDRA Management Board, Fukuoka, Japan, 6-7 November 2010

Sun, 07 Nov 2010 00:00:00 +0100

Special Session for non-ICH Members of ICH Global Cooperation Group Held at Board Meeting

Fukuoka, 7 November 2010 – The MedDRA Management Board met in Fukuoka, Japan on 6 – 7 November 2010. The Board held a special session for non-ICH members (APEC, ASEAN, GCC, SADC, China, Chinese Taipei, Singapore and South Korea) of the ICH Global Cooperation Group (GCG). During this session, the invited members were informed about MedDRA from the perspective of Board members including regulatory authority representatives. The Board supported extension of the Maintenance and Support Services Organization (MSSO) contract between IFPMA and Northrop Grumman Information Systems until end of 2016. The MedDRA Management Board approved the 2011 MedDRA subscription rates for MSSO subscribers; these have not increased for the sixth year in a row. Regulatory authorities, academic institutions, and individual healthcare professionals will continue to receive MedDRA and associated training for no cost. The Board noted that a Hungarian translation of MedDRA will be available to users in early 2011. The Board was updated on the activities of the Observational Medical Outcomes Partnership (OMOP) in which MedDRA is one of the terminologies involved. A representative of the ICH Advisory Panel for Standardised MedDRA Queries (SMQs) presented an update on the progress of SMQ development by the CIOMS SMQ Working Group. The Working Group has begun to wind down its development of new SMQs and looks forward to focusing on other topics to promote the utility of SMQs in support of pharmacovigilance activities. The Japanese Management Board (JMB) reported on the activities of the Japanese Maintenance Organization, noting the sustained interest of Japanese MedDRA users on updates to the terminology and in MedDRA training. The next scheduled meeting of the Board will be on 11 - 12 June 2011 in Cincinnati, USA.

For further information, please contact:

ICH Secretariat, c/o IFPMA, Chemin Louis-Dunant, 15, P.O Box 195, 1211 Geneva 20, Switzerland. Tel: +41 22 338 3206 E-mail: admin@ich.org
Fax: +41 22 338 3230 Web site: www.ich.org

ICH Celebrates 20 Years

Thu, 16 Dec 2010 00:00:00 +0100

ICH Celebrates 20 Years with a Refreshed and Revitalised New Visual Identity

December 16, 2010 As part of its 20th Anniversary celebration, ICH is pleased to announce the launch of a new logo and a new look for the ICH website.

Logo

ICH’s new logo has been designed with a view to representing the letters “I”, “C”, “H” in a manner which speaks to the benefits of harmonisation for better global health. This has been achieved through the embodiment of the letters in an abstract human form. The principle colour of the logo is blue, a colour often synonymous with healthcare, and which adds an air of vitality and wellbeing to the depicted abstract figure. Purple was chosen as being complementary to blue.

Slogan

The new ICH logo also includes the slogan “Harmonisation for Better Health”, which further emphasises the benefits of harmonisation for better global health and is also reflective of ICH’s Terms of Reference.

Website

Taking inspiration from the logo, the ICH website has been redesigned to have a consistent look and feel. All information has been restructured with emphasis given to ongoing harmonisation activities, as well as how to contribute to Guideline development. In addition, to allow you to easily stay up-to-date, a RSS feed and other social media tools have been integrated. The new website is also reflective of the evolution which ICH has undergone over the past 20 years. Originally involving Europe, Japan and the USA, today, through the activities of the ICH Global Cooperation Group, countries and regions from across the globe are actively involved in ICH. In line with this increasing interest in the utilisation of ICH Guidelines, the new website gives important focus to ICH training and capacity building activities. Download the Press Release ICH 20th Anniversary Publication