Articles & Procedures
Articles & Procedures
ICH Articles of Association
The ICH Articles of Association were adopted by ICH Founding Members at the ICH Inaugural Assembly on October 23, 2015. The Articles provide the purpose and aims of the ICH Association, define ICH's governance and membership structure, and set forth the financial means to be used by ICH to achieve its purpose.
📄 Download the ICH Articles of Association (v8.0)Approved by the Assembly on 13 May 2025
Rules of Procedure
While the work of ICH bodies and the MedDRA Steering Committee is governed by the ICH Articles of Association, the Rules of Procedure have been developed to provide guidance and interpretation in respect of the provisions of Articles relating to the Assembly, the Management Committee and the MedDRA Steering Committee.
The Assembly, the Management Committee and the MedDRA Steering Committee are responsible for adopting their own Rules of Procedure in line with the ICH Articles of Association.
Standard Operating Procedures of the ICH Working Groups
The ICH Management Committee is responsible for the oversight of the ICH Working Group and has developed Standard Operating Procedures to provide an overview of the standard processes for the harmonisation activities that take place under the ICH Association and to provide guidance for the Working Groups that carry out these activities.
The version 13.1 is an intermediary version to redistribute, remove or replace Annexes as per List of Annexes (p. 35) in anticipation of SOP overhaul approved by the ICH Management Committee:
📄 Download the Standard Operating Procedures document (v13.1)