International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

The Steering Committee, made of six ICH Parties, governs the ICH, determining the policies and procedures, selecting topics for harmonisation and monitoring progress of harmonisation initiatives. The ICH consists of:

Steering Committee

The ICH has four major parts:

  • Steering Committee

  • Coordinators

  • Secretariat

  • Working Groups

ICH Structure

The ICH Coordinators represents each ICH Party to the ICH Secretariat on a day-to-day basis.

Coordinators

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

Secretariat

The ICH Working Groups are 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.

Working Groups