An ICH Working Group (WG) is established for each technical topic selected for harmonisation.

There are several different types of ICH working group:

  • EWG: Expert Working Group is charged with developing a harmonised guideline that meets the objectives in the Concept Paper and Business Plan.
  • IWG: Implementation Working Group is tasked with developing Q&As to facilitate implementation of existing guidelines.
  • Informal Working Group: Is formed prior to any official ICH harmonisation activity with the objectives of developing/finalising a Concept Paper, as well as developing a Business Plan.
  • Discussion Group: Is a group established to discuss specific scientific considerations or views i.e. Gene Therapy Discussion Group (GTDG), and ICH & Women Discussion Group.

ICH Members and Observers appoint experts to participate in the WGs in line with the applicable procedures in the Assembly Rules of Procedure and EWG/IWG Standard Operating Procedures. A Rapporteur from one of the Members is designated by the Assembly to lead the scientific discussions of the WG.

The Management Committee oversees the work of the WGs on an ongoing basis, while the Assembly receives reports on each WG’s progress at the time of its biannual face-to-face meetings.

Each WG also maintains a work plan which is available on the ICH website under each topic of the ICH Guideline page (see related links).