Latest Press Release

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

Thu, 10 Nov 2011 00:00:00 +0000

“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, 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 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 00:00:00 +0000

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 08:09:00 +0100

“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 00:00:00 +0100

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

Wed, 10 Nov 2010 23:00:00 +0000

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

Sat, 06 Nov 2010 23:00:00 +0000

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

Wed, 15 Dec 2010 23:00:00 +0000

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