The ICH M4Q(R2) draft Guideline “The Common Technical Document (CTD) for the Registration of Pharmaceuticals for Human Use: Quality” was endorsed by the ICH Assembly (at Step 2a/b of the ICH process) at the Madrid meeting in May 2025.
This multidisciplinary revision updates the structure and content of CTD Modules 2 and 3 to better support the registration and lifecycle management of all pharmaceutical products, including complex modalities such as biologics, gene therapies, vaccines, and combination products