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.

  • Membership application

    • Any Regulatory party eligible as a Member in accordance with the ICH Articles of Association Article 11.1, Legislative or administrative authority, or Article 11.2, Regional Harmonisation Initiative, can apply for ICH Membership.

       

      You are invited to fill the appropriate application form for Regulatory Membership 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 Regulatory party.

    • Any Industry international organisation eligible as a Member in accordance with the ICH Articles of Association Article 12.1, 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 for Industry Membership 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.

  • Observership application

    • Any Regulatory party eligible as an Observer in accordance with the ICH Articles of Association Article 17.1(a), legislative or administrative authority, or Article 17.1(b), Regional Harmonisation Initiative, can apply for ICH Observership.

       

      You are invited to fill the application form for Regulatory Observership 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 Regulatory party.

    • Any international industry organisation eligible as 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 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 form for Observership application for International pharmaceutical industry organisations.

    • Any Industry international organisation eligible as 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 form for Observership application for International organisations.