The International Council for Harmonisation (ICH) has published the draft M4Q(R2) Guideline: The Common Technical Document for the Registration of Pharmaceuticals for Human Use – Quality
The draft M4Q(R2) guideline introduces a modernized structure and enhanced clarity for quality submissions. It is designed to improve the efficiency of both regulatory submissions and reviews, supporting science- and risk-based approaches. Ultimately, this will contribute to more timely access to safe, effective, and high-quality medicines for patients around the world.
Congratulations to the M4Q(R2) Expert Working Group on reaching this key step! We look forward to the next phase of public consultation and continued collaboration toward finalizing this impactful guideline.