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Pharmaceuticals

M4Q

Friday, May 8, 2026
12:30 - 13:30 WEST
Location: Auditorium 3

Description: ICH M4Q (R2) will fundamentally alter how one of the three pillars (Quality / CMC) of a regulatory dossier is presented to regulators and represents the biggest shakeup to Module 3 and Module 2.3 content since the introduction of the Common Technical Document (CTD). The draft ICH M4Q(R2) guideline is currently at Draft ICH Step 2 Version.
This session will begin with a perspective from the regulator – and cover the rationale for the revision, the revision objectives and approach, with a focus on the M4Q(R2) design, including the respective updated structures of M4Q(R2) Modules 2.3 and 3. It will provide insights from the EFPIA representative on the ICH M4Q(R2), with a focus on getting the new guideline across line. Key topics from the public consultation, the road ahead to finalise, and the future implementation will all be explored. Lastly, the session will examine whether industry needs from R2 and if they have been met and how to prepare for implementation