M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality; International Council for Harmonisation; Draft Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality." The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance is intended to establish a globally harmonized framework to organizing and presenting quality data included in registration applications for medicinal products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 The draft guidance updates the quality section of the common technical document (CTD) to further improve registration and life cycle management efficiency, facilitate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.