ICH Releases Draft M4Q(R2) Guideline for Public Comment

In May 2025, the International Council for Harmonisation (ICH) published the draft M4Q(R2) guideline, titled "The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality," on its official website.

This revision updates Modules 2 and 3 of the CTD to better reflect essential quality-related data required for marketing authorization and lifecycle management of both chemically and biotechnologically produced pharmaceuticals.

The update aims to streamline regulatory submissions and enhance review efficiency.

EMA and Swissmedic have launched public consultations and posted the draft on their respective websites. Stakeholders are invited to submit feedback by 24 October 2025.

Detailed instructions for the commenting process are available through the EMA and Swissmedic portals.

This revision marks a step forward in harmonizing global pharmaceutical quality standards and improving regulatory clarity.

30-07-2025