Which group is responsible for adopting the guideline under Step 4 in the ICH process?

• A. ICH Steering Committee
• B. ICH Expert Working Group
• C. ICH Assembly of Regulators
• D. Regulatory Members of the ICH Assembly

Answer: (D)

Step 4 of the ICH process is the formal adoption of the guideline by the regulatory authorities across the ICH regions. The group responsible for this adoption is the regulatory members of the ICH Assembly. They review the draft, consider public feedback, and then officially adopt the guideline for implementation in their jurisdictions. The drafting work is done by the Expert Working Group, while the Steering Committee guides governance and oversight; neither of these perform the formal adoption.