4. International Council on Harmonisation (ICH): Elaboration of ICH guidelines

The ICH Expert Working Groups (EWG) follow a formalised structure when elaborating guidelines.

Before starting a project to develop or elaborate a new guideline, the EWG drafts a concept paper.
The Management Committee must endorse the project.
The EWG then appoints a rapporteur. This rapporteur may be an industry delegate or a regulator.
The entire membership of the EWG will need to agree on the draft guideline - called the ‘Technical Document’ [Step 1].
Next, the regulators will formally adopt the draft guideline and publish it for external consultation in the ICH regions [Step 2].
In Step 3, the EWG will discuss the comments received during the consultation period. Industry delegates still participate in the discussions. However, if the initial rapporteur was from industry If the initial rapporteur was from regulatory, no changes are necessary.
In the adoption phase only the regulatory members will sign off as the guideline is formally a regulatory document. [Step 4].
Delegates from observers may participate in EWG meetings and discussions but without any voting rights.
Implementation of new ICH guidelines will follow regional procedures [Step 5]. In the EU, a new ICH guideline is tabled for the Committee for Medicinal Products for Human Use (CHMP) who will formally adopt it. The guideline is published similarly to EU guidelines. The new guideline is labelled as a CHMP/ICH guideline.

Many guidelines have been developed via ICH collaboration: (accessed on ICH website January 2021)