Swissmedic/EMA: M4Q(R2) Guideline published for Comment

The draft guideline "THE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE: QUALITY M4Q(R2)" of the ICH (INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE) was published on the ICH website in May 2025, as reported in the news "ICH M4Q Guideline Updated".

This new version focuses on the revision of the quality-related information in Module 2 and 3 of the CTD to capture all necessary quality-related information for the authorisation and lifecycle management of medicinal products for human use. It will apply to active substances and finished medicinal products, which can be manufactured both chemically and biotechnologically, and is intended, among other things, to promote the efficiency and effectiveness of submissions and authorisation processing.

The EMA and Swissmedic have now started the consultation phases and published the draft guideline on their websites. Comments and observations on the new draft directive can be submitted until 24 October 2025.

The explanations and information on the respective commenting procedures can be found on the websites of Swissmedic and EMA.