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, approved by Assembly on May 31, 2017

 

Rules of Procedure

While the work of ICH bodies is governed by the ICH Articles of Association, 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 Management Committee. Each body is responsible for adopting its own Rules of Procedure in line with the ICH Articles of Association.

Assembly Rules of Procedure

Download the Assembly Rules of Procedure, approved by Assembly on May 31, 2017

Management Committee Rules of Procedure

Download the Management Committee Rules of Procedure, approved by MC on May 29, 2017

MedDRA Management Committee Rules of Procedure

Download the MedDRA Management Committee Rules of Procedure, approved by MedDRA MC on November 5, 2016

 

Standard Operating Procedures for 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 harmonization activities that take place under the ICH Association and to provide guidance for the Working Groups that carry out these activities. 

Download the Standard Operating Procedures document, approved by MC on May 29, 2017