Who endorsed E6(R3) on 19 May 2023, leading to public consultation?

• A. Members of the ICH Assembly
• B. National regulatory authorities
• C. Pharmaceutical sponsors
• D. Independent Ethics Committees

Answer: (A)

Endorsement for public consultation of an ICH guideline comes from the ICH Assembly. This body is the decision-making group that brings together regulatory authorities and industry representatives from ICH member regions. On 19 May 2023, the ICH Assembly formally endorsed E6(R3), which then opened it up for public comment.

National regulatory authorities will later implement the final guideline in their jurisdictions, and pharmaceutical sponsors or Independent Ethics Committees don’t have the authority to endorse guidelines for public consultation. The Assembly’s endorsement is the formal step that triggers the public consultation phase.