ICH M4Q(R2): From Static CTD to Living CMC Knowledge – What the Draft Really Changes
8 Mar , 2026 - Regulatory,Education
When the ICH M4 guideline was finalized more than twenty years ago, the Common Technical Document (CTD) represented a major milestone for global regulatory harmonisation. For the first time, regulators and industry shared a common structure for presenting pharmaceutical quality information. But the world of CMC has changed dramatically since then. The draft ICH M4Q(R2) […]