Issue Date: January 20, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Multidisciplinary
Status: Draft
M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality.” The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance is intended to establish a globally harmonized framework to organizing and presenting quality data included in registration applications for medicinal products for human use. The draft guidance updates the quality section of the common technical document (CTD) to further improve registration and life cycle management efficiency, facilitate digitalization and knowledge management, and support provisions for emerging technologies.
Download the Guidance Document
