The questions and answers below aim to addressing some of the general questions that visitors to the ICH website might have about ICH.

  • ICH Objectives

    • When ICH was first established, one of the objectives was to organise an International Conference on Harmonisation, and hence the name which was given to the initiative. Between 1991 and 2003, six International Conferences on Harmonisation were organised.

      In 2007, the ICH Steering Committee agreed to the organisation of smaller, more frequent and more focused ICH public meetings, in lieu of the previously organised international ICH Conferences. It was agreed that these public meetings would take place either as one-day meetings at the end of ICH Steering Committee meetings, or as ICH-branded regional meetings in collaboration with other non-profit organisations.

    • The objective of ICH is to increase international harmonisation of technical requirements to ensure that safe, effective, and high quality medicines are developed and registered in the most efficient and cost-effective manner. These activities have been undertaken to promote public health, prevent unnecessary duplication of clinical trials in humans, and minimize the use of animal testing without compromising safety and effectiveness.

    • The complete name of ICH is the "International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use"

    • ICH is a joint initiative involving both regulators and research-based industry representatives of the European Union, Japan and the USA in scientific and technical discussions of the testing procedures required to assess and ensure the safety, quality and efficacy of medicines.

    • The goal of ICH is to promote international harmonisation by bringing together representatives from the three ICH regions (EU, Japan and USA) to discuss and establish common guidelines.
      Another goal of ICH is to make information available on ICH, ICH activities and ICH guidelines to any country or company that requests the information, and to promote a mutual understanding of regional initiatives in order to facilitate harmonisation processes related to ICH guidelines regionally and globally, and to strengthen the capacity of drug regulatory authorities and industry to utilise them. The GC session which was established in 2013 as an evolution of the GCG (created in 1999) continues to be charged with this task.

  • ICH Organisational Structure

    • Regional Harmonisation Initiatives (RHIs) namely Asia-Pacific Economic Cooperation (APEC), Association of Southeast Asian Nations (ASEAN), East African Community (EAC), Gulf Cooperation Countries (GCC), Pan American Network on Drug Regulatory Harmonization (PANDRH) and South African Development Community (SADC), have been invited to designate permanent representatives to participate in the ICH meetings (i.e., ICH SC meeting including its Global Cooperation session, EWGs/IWGs meetings, MedDRA Management Board Special Session). RHIs are founded on the principle of harmonising drug regulation across a defined group of non-ICH countries.

    • The ICH Observers include the European Free Trade Association (EFTA) - currently represented by Swissmedic (Swiss Agency for Therapeutic Products), Health Canada and World Health Organization (WHO). The Observers have been associated with the ICH process from the beginning to act as a link with non-ICH countries and regions.

    • The Coordinators are fundamental to the smooth running of the ICH and are nominated by each of the six parties. An ICH Coordinator acts as the main contact point with the ICH Secretariat. Due to structural differences within the EU and MHLW, ICH Technical Coordinators are also designated from the EMA and PMDA respectively.

    • Drug Regulatory Authorities and Departement of Health of Australia, Brazil, China, Chinese Taipei, India, Russia, Singapore and South Korea, have been invited to designate permanent representatives to participate in the ICH meetings (i.e., ICH SC meeting including its Global Cooperation session, EWGs/IWGs meetings, MedDRA Management Board Special Session).

    • The ICH Global Cooperation Group (GCG) was formed in March 1999, as a subcommittee of the ICH Steering Committee. It was made up of one representative from each of the six parties on the ICH Steering Committee (EU, EFPIA, MHLW, JPMA, FDA, PhRMA) and the ICH Observers (Health Canada, EFTA and WHO).

      In addition to its ICH members, the GCG also had participation from regions and countries beyond ICH with representatives of other Regional Harmonisation Initiatives (RHIs), as well as Drug Regulatory Authorities (DRAs) and Departments of Health (DoHs) invited to attend.

      ICH has recognised the need for changes to mirror global face of drug development, and in June 2013, the ICH Steering Committee endorsed a new format for the GCG which was incorporated into a standing agenda item of the SC agenda entitled Global Cooperation (GC) session. The GC session maintains current GCG arrangements regarding RHIs/DRAs/DoH participation. The GC session gathers ICH SC members from each of the six parties on the ICH SC, the ICH Observers; in addition to representatives from six Regional Harmonisation Initiatives (RHIs) and representatives from eight individual Drug Regulatory Authorities and Department of Health (DRAs/DoH).

      Current RHIs and DRAs/DoH participants include representatives from the Asia-Pacific Economic Cooperation (APEC), the Association of Southeast Asian Nations (ASEAN), the East African Community (EAC), the Gulf Cooperation Council (GCC), the Pan American Network on Drug Regulatory Harmonization (PANDRH), the South African Development Community (SADC), Australia, Brazil, China, Chinese Taipei, India, South Korea, Russia and Singapore.

    • The ICH Secretariat can be reached at:

      ICH Secretariat
      15 chemin Louis-Dunant
      P.O. Box 195
      1211 Geneva 20
      Switzerland

      Tel :  +41 (22) 338 32 06
      Fax: +41 (22) 338 32 30
      e-mail: admin@ich.org

    • The ICH Secretariat provides support to the ICH Steering Committee.

      The Secretariat is primarily concerned with preparations for, and documentation of, meetings of the Steering Committee (SC) as well as coordination of preparations for Working Group (EWG, IWG, Informal WG) and Discussion Group meetings.

      The Secretariat also provides administrative support for Regional Harmonisation Initiatives (RHIs), Drug Regulatory Authorities (DRAs) and Department of Health (DoH) representatives and for the preparation of the Global Cooperation (GC) session of the SC.

      Information on ICH Guidelines and the general ICH process can be obtained from the ICH Secretariat.

      Coordination with the MedDRA Management Board for the international medical dictionary created by the ICH process is also part of the Secretariat's responsibilities.

    • The MedDRA Management Board is appointed by the ICH Steering Committee to oversee the activities of the "Maintenance and Support Services Organization" (MSSO) for MedDRA, and ensure that the MSSO is meeting the various needs of MedDRA users. The Management Board is composed of one representative from each of the six ICH parties and one representative from the Medicines and Healthcare products Regulatory Agency of UK (MHRA UK) and Health Canada. The IFPMA acts as a non-voting observer on the Management Board and chairs the Board.

    • The Steering Committee is the body that governs the ICH, determines the policies and procedures for ICH, selects topics for harmonisation and monitors the progress of harmonisation initiatives. Each of the six ICH parties has two seats on the ICH Steering Committee. Each of the Observers nominates non-voting participants to attend the ICH Steering Committee Meetings. IFPMA also participates as a non-voting member.

    • The ICH structure consists of the ICH Steering Committee (SC), ICH Coordinators, ICH Secretariat and ICH Working Groups.

      The ICH MedDRA Management Board is a sub-committee of the ICH SC and the Global Cooperation is a session of the ICH SC which welcomes representatives from Regional Harmonisation Initiatives and individual Drug Regulatory Authorities from beyond ICH Regions.

    • The ICH Parties are the founding members of ICH and represent the regulatory bodies and research-based industry in the EU, US and Japan.

    • ICH is comprised of representatives from six parties that represent the regulatory bodies and research-based industry in the European Union, Japan and the USA.

      In Japan, the members are the Ministry of Health, Labour and Welfare (MHLW), and the Japan Pharmaceutical Manufacturers Association (JPMA).

      In Europe, the members are the European Union (EU), and the European Federation of Pharmaceutical Industries and Associations (EFPIA).

      In the USA, the members are the Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of America (PhRMA).

      Additional members include Observers from the World Health Organization (WHO), European Free Trade Association (EFTA, currently represented by Swissmedic), and Canada (Health Canada). 

      The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) has been closely involved with ICH since its inception.

    • ICH does not have "offices" as such because it is a voluntary cooperative effort of cosponsors from the three regions. The ICH Secretariat is based in Geneva. The biannual meetings and conferences of the ICH Steering Committee rotate between the EU, Japan, and the USA. 

  • ICH Harmonisation Process

    • The Formal ICH procedure is a stepwise process. Preliminary discussions of which, consider existing guidelines in the region and elsewhere, known areas of similarity and differences, and scientific advances in the subject area. Under the leadership of the Rapporteur and in collaboration with the Regulatory Chair, drafts are prepared and circulated through many revisions until a "final harmonised draft" of the technical document is completed (Step 1). This draft is signed by the EWG as the agreed-upon draft and forwarded to the Steering Committee for signing which signifies acceptance for consultation by each of the six co-sponsors (Step 2a). On the basis of the technical document, the three regulatory parties will take actions they deem necessary to develop the "draft Guideline" (Step 2b).

      The three regulatory sponsors initiate their normal consultation process to receive comments (Step 3). This comment period normally takes six months.

      After obtaining all regulatory consultation results, the EWG who organised the discussion for consensus building will be resumed. This EWG consists of regulatory and industry parties, and Observers. If the Rapporteur was designated from an industry party until Step 2, then a new Rapporteur will be appointed from the regulatory party, preferably from the same region as the previous Rapporteur. The Regulatory Chair remains the same. The same procedure described in Step 1 is used to address the consultation results into the Step 2b Final Draft Guideline. The draft document to be generated as a result of the Step 3 phase is called Step 3 Experts Draft Guideline.

      If both regulatory and industry parties of the EWG are satisfied that the consensus achieved at Step 2b is not substantially altered as a result of the consultation, or consensus is reached on any alterations, the Step 3 Experts Draft Guideline is signed by the EWG regulatory experts. The Step 4 document with regulatory EWG signatures is submitted to the Steering Committee to request adoption as Step 4 of the ICH process.

      Step 4 is reached when the Steering Committee agrees that there is sufficient scientific consensus on the technical issues. This endorsement is based on the signatures from the three regulatory parties to ICH affirming that the Guideline is recommended for adoption by the regulatory bodies of the three regions.

      The process is complete when the guidelines are incorporated into national or regional internal procedures (Step 5).

    • When one of the six parties feels that it has a suitable topic for harmonisation, the party prepares a proposal (or concept paper) that outlines the subject, the need for harmonisation, the anticipated effort and timetable for completion, and a recommendation on the type of working group required. The Steering Committee discusses intensively before deciding whether or not a topic requires harmonisation.

    • ICH operates through the ICH Steering Committee with administrative support from the ICH Secretariat and ICH Coordinators. The Steering Committee meets at least twice a year, rotating meeting sites among the three regions. During these meetings, new topics will be considered for adoption, reports are received on the progress of existing topics, and maintenance and implementation of the guidelines are discussed. The topics identified for harmonisation by the Steering Committee are selected from Safety, Quality, Efficacy, and Multidisciplinary matters.
      Working Groups also meet during the same week as the Steering Committee meetings and report on their progress to the Committee. Considerable work also occurs between meetings.

    • Interested Parties are those organisations that are expected to implement or to be regulated by the outcome of ICH efforts. These parties include the World Self-Medication Industry (WSMI) and the International Generic Pharmaceutical Alliance (IGPA), and other parties as determined by the Steering Committee. Where deemed appropriate, the Steering Committee may invite nominations from Interested Parties to Working Groups (EWG, IWG, Informal Working Group) or Discussion/Brainstorming Groups.

    • An Informal Working Group is either an informal EWG or IWG formed prior to any official ICH harmonisation activity with the objectives of developing/finalising a Concept Paper, as well as developing a Business Plan. To each informal working group, each of the six official ICH parties nominates official representatives and, unless otherwise specified by the Steering Committee, the official membership is limited to two officials per party per working group and one representative per ICH Observer, and also if applicable, one per interested party.

    • An Implementation Working Group is established by the Steering Committee to develop Q&As to facilitate the implementation of existing guidelines. Each of the six official ICH parties nominates official representatives and, unless otherwise specified by the Steering Committee, the official membership is limited to two officials per party per working group and one representative per ICH Observer, and also if applicable, one per interested party.

    • An Expert Working Group is created by the Steering Committee when a new topic is accepted for harmonisation, and is charged with developing a harmonised guideline that meets the objectives outlined in the Concept Paper and Business Plan. Each of the six official ICH parties nominates official representatives to each EWG and, unless otherwise specified by the Steering Committee, the official membership is limited to two officials per party per working group and one representative per ICH Observer, and also if applicable, one per interested party.

    • Depending on the type of harmonisation activity needed, the Steering Committee will endorse the establishment of one of three types of working group i.e., Expert Working Group (EWG), Implementation Working Group (IWG) or Informal Working Group.

    • Each of the 6 ICH Parties (EU, EFPIA, MHLW, JPMA, PhRMA & FDA) and the ICH Observers (WHO, EFTA & Health Canada) is responsible for nominating representatives to the ICH Steering Committee and to each ICH Working Group.
      Depending on the topic under harmonisation, other parties may also be invited by the ICH Steering Committee to nominate experts to ICH Working Groups. These parties include ICH Regional Pharmacopeias, ICH Interested Parties, as well as Regional Harmonisation Initiatives and Drug Regulatory Authorities from beyond ICH regions.

    • Everyone has the possibility to contribute to ICH through the regulatory consultation process. Under Step 3 of the ICH process, the Step 2 Guideline is subjected to regulatory consultation in the 3 ICH regions according to national/regional procedures. Comments received from regulatory consultation are considered by the EWG for incorporation into the final Step 4 Harmonised Tripartite Guideline which will be for regulatory implementation (Step 5) in the 3 ICH regions.
      If you are from an ICH region you can submit your comments to your Regulatory Authority. If you are from a non-ICH region you may submit your comments by e-mailing the ICH Secretariat at the following address Step2comments@ich.org. All comments received are transmitted to the appropriate EWGs for consideration.

  • ICH Work Products

    • The MedDRA MSSO offers training sessions to MedDRA subscribers. Courses are regularly scheduled and are available in various delivery methods e.g., face-to-face sessions and webinars.

      The ICH MedDRA Management Board has also directed the MedDRA MSSO to offer some free training courses for subscribers. Currently, the MSSO offers free face-to-face sessions on Coding with MedDRA and MedDRA Safety Data Analysis & SMQs. The MSSO provides also free webinars on introductory topics such as Introduction to MedDRA, MedDRA Coding Basics, Introduction to MedDRA Data Analysis and SMQs for Physicians, and What's New in MedDRA. The webinars include an expert instructor and training materials.

      The schedule for training available can be viewed on the MedDRA website.

      The MSSO also provides free short videocasts on a variety of MedDRA-related topics in several different languages. The videocasts can be downloaded or viewed directly from the training material page on the MedDRA website.

      The ICH MedDRA Management Board also works closely with the ICH Steering Committee to respond to requests for training on MedDRA from Regulators in regions and countries beyond ICH regions.

    • ICH has developed over 60 harmonised Guidelines aimed at eliminating duplication in the development and registration process, so that a single set of studies can be generated to demonstrate the quality, safety and efficacy of a new medicinal product. These Guidelines also include the Common Technical Document (CTD), which describes the common format for the preparation of a well-structured CTD for applications that will be submitted to regulatory authorities.

      In addition, the ICH is working to facilitate international electronic communication through the provision of Electronic Standards for the Transfer of Regulatory Information (ESTRI) that will meet the requirements of the pharmaceutical companies and regulatory authorities. A product of this has been the Electronic Common Technical Document (eCTD), which allows for the electronic submission of the Common Technical Document (CTD) from applicant to regulator.

      The Medical Dictionary for Regulatory Activities (MedDRA) Terminology has also been developed under the auspices of ICH.

    • The ICH Guidelines represent agreed-upon scientific guidance for meeting technical requirements for registration within the three ICH regions - EU, US and Japan. Each regulatory co-sponsor implements the guidelines according to its national/regional requirements. The ICH Guidelines are not intended to be comprehensive guidance covering all aspects of product development and registration. They are intended to be used in combination with any regional requirements. An ICH Guideline can be used by industry as a means of reducing testing duplication.

    • You can register for the RSS feed on the ICH website to receive a notice everytime a new Guideline is added or modified on the website. Also, on the home page of the ICH website, you can refer to the news section which will inform you of any new Guideline published.

    • The ICH Guidelines are only made officially available by ICH in English. However, some of the regulatory authorities involved in the ICH process develop their own translations.

      Japanese translations of all ICH Guidelines are made available by the Japanese Pharmaceutical and Medical Devices Agency (PMDA) and can be found on the PMDA website.

      Health Canada translates all ICH Guidelines which it adopts into French and makes these available on the Health Canada website.
      US FDA makes available a Spanish translation of the E6 Guideline on its website.

    • The ICH policy is that the materials provided on the ICH website are made available for public use, reproduction or distribution, provided that a clear reference to ICH as the copyright holder is made. In case of any adaptation or modification of the materials, the changes made to the original materials must be clearly labeled and any impression that these changes are endorsed by the ICH must be avoided. The above-mentioned permissions do not apply to third party content which may be included in some ICH materials. Any third party content included in ICH materials will be clearly identified. Permission for public use, reproduction, distribution or modification of such third party content must be obtained directly from the relevant third party.

      In the case of ICH Implementation Guides containing third party material from HL7, HL7 has granted ICH permission for this use. Users may republish these ICH Implementation Guides in the form they appear on the ICH website without infringing HL7 copyright. However permission must be obtained directly from HL7 for any further use or modification of this material.

    • The official language for ICH Guidelines is English. Everybody is welcome to translate the ICH Guidelines. However, any impression that the translation of the original document is endorsed or sponsored by the ICH must be avoided as the ICH Steering Committee cannot certify that the translation reflects accurately the original intent of the ICH Guidelines.

      The above-mentioned permission does not apply to third party content which may be included in some ICH materials. Any third party content included in ICH materials will be clearly identified. Permission for translation must be obtained directly from the relevant third party.

    • In addition to the Drug Regulatory Authorities (DRAs) of Europe, Japan and the US, many other DRAs worldwide have chosen to implement some or all of the ICH Guidelines in their regulations. For further information it is suggested to contact individual DRAs.

    • MedDRA is the Medical Dictionary for Regulatory Activities Terminology (MedDRA) and has been developed under the auspices of ICH. It provides an international medical dictionary applicable to all phases of product development.

      The MedDRA Maintenance and Support Services Organization (MSSO) holds a contract with the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) as a trustee of the Steering Committee to maintain and develop the terminology to meet Users' needs. For more information regarding the terminology, including how to subscribe or obtain training, see http://meddra.org/.

    • Industry and governments in ICH and non-ICH countries can use the ICH Guidelines to address technical issues during the product development process. In addition to providing state-of-the-art guidance, the Guidelines may well also serve as teaching tools. Harmonised ICH Guidelines can reduce duplication in meeting technical requirements, thereby saving financial and material resources.

    • MedDRA is available on subscription from the MedDRA Maintenance and Support Services Organization (MSSO). Various subscription types are available depending on the intended use of MedDRA, the type of organisation, as well as total annual revenues for the organisation. MedDRA is available free of charge to all Regulators worldwide, direct healthcare providers and other non-profit organisations.

      For further information on subscribing to MedDRA, visit the MSSO website or contact Mr. Patrick Revelle at MedDRA MSSO: Patrick.Revelle@meddra.org.

    • Through the ICH Global Cooperation (GC) session of the ICH Steering Committee, ICH responds to requests for training and capacity-building from the Regional Harmonisation Initiatives (RHI) and individual Drug Regulatory Authorities/Departments of Health (DRA/DoH) invited by the ICH SC to participate in the GC sessions. The way in which ICH responds to such requests is to provide assistance in programme development and to identify ICH experts to participate in events organised by RHI and DRA/DoH. These training events are of various types, with some being open to the general public, while others may be specifically targeted at regulators and/or local industry.

      In addition, upon SC approval, workshops on specific ICH topics are organised, sometimes with co-sponsorship from external organisations. Details of such events are made available on the training page on the ICH website.