ICH is a truly global platform for harmonisation for better health, bringing together regulators, industry and other actors from six continents. In 2025, ICH celebrated its 35-year history as a successful and proven forum for delivering harmonised scientific and technical guidelines developed through dialogue between regulators and industry experts.
ICH membership provides a direct voice in the development and implementation of impactful, harmonised, international pharmaceutical guidelines, and access to an engaged global network of regulators and industry experts. The results facilitate the development and regulation of safe, effective and high-quality medicines worldwide.
Here are some of the advantages of ICH Membership:
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Becoming a Member of the ICH Association sends a clear message that the regulatory authority and the regulated industry are committed to aligning with the highest global standards for the quality, efficacy and safety of medicinal products. Membership in ICH shows institutional integrity and brings recognition, as ICH guidelines are widely recognised and are applied in many countries around the world. With ICH Membership also comes the right to use the ICH Member Logo to denote Membership in a Member’s own publications, presentations and website.
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Being an ICH Member gives the opportunity to be fully involved in the public health work of achieving greater harmonisation in the interpretation and application of technical guidelines and requirements for medicinal product development and registration.
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All ICH Members participate in the consensus-building and decision-making in the ICH Assembly. They can also propose new topics, participate in the selection of topics for harmonisation and nominate technical experts to contribute to current harmonisation activities. Where consensus cannot be reached, Regulatory Members have the right to vote on items such as the endorsement of draft ICH guidelines and adoption of final ICH guidelines.
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All Members have a say on ICH operational decisions such as approval of new Members, Observers, annual budget and membership fees. And since 2018, all Members have the possibility to be elected to the ICH Management Committee.
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Membership in ICH allows for building and strengthening working relations between Members. For Regulatory Members in particular, harmonisation at the multilateral level provides a strong common foundation to develop bilateral regulatory cooperation, such as for the exchange of information, training and reliance practices.
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In addition to the information available on the ICH public website, Members are regularly updated on a broad range of ICH issues and on other related activities.
The eligibility criteria for becoming an ICH Member or Observer are detailed in the ICH Articles of Association (Articles 11, 12 and 17) and in the ICH Assembly Rules of Procedure (Sections 1 and 2), available for download on the Articles and Procedures page.
If you have any questions concerning the application process, please do not hesitate to contact the ICH Secretariat at application@ich.org.
Any Regulatory party eligible to be a Member in accordance with the ICH Articles of Association Article 11.1 as a legislative or administrative authority can apply for ICH Membership.
You are invited to fill the appropriate application form and return it to the ICH Secretariat at application@ich.org. All parts of the application form should be fully filled and any necessary documentation provided.
The ICH Management Committee will process the applications in accordance with the Rules of Procedures and make a recommendation to the ICH Assembly which will be invited to take a decision on Membership admission. As per the ICH Articles of Association, the Assembly should take a decision on the Membership admission as soon as possible in any of its subsequent meetings.
Download the form for Membership application for legislative or administrative authority.
Expedited Membership procedure: Observers eligible for ICH Membership under the expedited procedure further to Article 11.1 third paragraph can apply under the expedited procedure.
Download the form for Membership application for legislative or administrative authority under the expedited procedure.
Any Regulatory party eligible to be a Member in accordance with the ICH Articles of Association Article 11.2 as a Regional Harmonisation Initiative can apply for ICH Membership.
You are invited to fill the appropriate application form and return it to the ICH Secretariat at application@ich.org. All parts of the application form should be fully filled and any necessary documentation provided.
The ICH Management Committee will process the applications in accordance with the Rules of Procedures and make a recommendation to the ICH Assembly which will be invited to take a decision on Membership admission. As per the ICH Articles of Association, the Assembly should take a decision on the Membership admission as soon as possible in any of its subsequent meetings.
Download the form for Membership application for Regional Harmonisation Initiative.
Expedited Membership procedure: Observers eligible for ICH Membership under the expedited procedure further to Article 11.2 third paragraph can apply under the expedited procedure.
Download the form for Membership application for Regional Harmonisation Initiative under the expedited procedure.
Any Industry international organisation eligible to be a Member in accordance with the ICH Articles of Association Article 12.1 as an international organisation representing the industry of pharmaceutical products for human use can apply for ICH Membership.
You are invited to fill the appropriate application form and return it to the ICH Secretariat at application@ich.org. All parts of the application form should be fully filled and any necessary documentation provided.
The ICH Management Committee will process the applications in accordance with the Rules of Procedures and make a recommendation to the ICH Assembly which will be invited to take a decision on Membership admission. As per the ICH Articles of Association, the Assembly should take a decision on the Membership admission as soon as possible in any of its subsequent meetings.
Download the form for Membership application for international pharmaceutical industry organisations.
Any Regulatory party eligible to be an Observer in accordance with the ICH Articles of Association Article 17.1(a) as a legislative or administrative authority can apply for ICH Observership.
You are invited to fill the appropriate application form and return it to the ICH Secretariat at application@ich.org. All parts of the application form should be fully filled and any necessary documentation provided.
The ICH Management Committee will process the applications in accordance with the Rules of Procedures and make a recommendation to the ICH Assembly which will be invited to take a decision on Observership admission. As per the ICH Articles of Association, the Assembly should take a decision on the Observership admission as soon as possible in any of its subsequent meetings.
Download the form for Observership application for a regulatory party.
Any Regulatory party eligible to be an Observer in accordance with the ICH Articles of Association Article 17.1(b) as a Regional Harmonisation Initiative can apply for ICH Observership.
You are invited to fill the appropriate application form and return it to the ICH Secretariat at application@ich.org. All parts of the application form should be fully filled and any necessary documentation provided.
The ICH Management Committee will process the applications in accordance with the Rules of Procedures and make a recommendation to the ICH Assembly which will be invited to take a decision on Observership admission. As per the ICH Articles of Association, the Assembly should take a decision on the Observership admission as soon as possible in any of its subsequent meetings.
Download the form for Observership application for Regional Harmonisation Initiative.
Any international industry organisation eligible to be an Observer in accordance with the ICH Articles of Association Article 17.1(c), international pharmaceutical industry organisation, who wishes to apply for ICH Observership should, prior to application, submit a written expression of interest to the ICH Secretariat seeking to exceptionally attend an Assembly meeting as an Ad-hoc Observer. The expression of interest should explain the international organisation’s interest in ICH and interest in potentially applying to become an Observer.
You are invited to fill the pre-application form for expression of interest for International Pharmaceutical Organisation Observership and return it to the ICH Secretariat at application@ich.org. All parts of the form should be fully filled and any necessary documentation provided.
The Management Committee will process the expressions of interest in accordance with the Rules of Procedures and decide whether to extend an invitation to participate in the forthcoming Assembly meeting as an Ad-hoc Observer. Please refer to the Assembly Rules of Procedure Section 2.2.2 for more information on this process.
Download the pre-application form for expression of interest for International Pharmaceutical Industry Organisation Observership.
Any international organisation eligible to be an Observer in accordance with the ICH Articles of Association Article 17.1(d), international organisations that are represented at a global level whose work and/or membership is regulated or affected by ICH Guideline(s), who wishes to apply for ICH Observership should, prior to application, submit a written expression of interest to the ICH Secretariat seeking to exceptionally attend an Assembly meeting as an Ad-hoc Observer. The expression of interest should explain the international organisation’s interest in ICH and interest in potentially applying to become an Observer.
You are invited to fill the pre-application form for expression of interest for International Organisation Observership and return it to the ICH Secretariat at application@ich.org. All parts of the form should be fully filled and any necessary documentation provided.
The Management Committee will process the expressions of interest in accordance with the Rules of Procedures and decide whether to extend an invitation to participate in the forthcoming Assembly meeting as an Ad-hoc Observer. Please refer to the Assembly Rules of Procedure section 2.2.2 for more information on this process.
Download the pre-application form for expression of interest for International Organisation Observership.