News Brief: FDA Issues Draft Guidance Updating Quality Standards for Global Drug Registration

The U.S. Food and Drug Administration (FDA) has released a draft guidance titled “M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality,” aimed at modernizing how quality information is organized and presented in drug registration applications.

The draft guidance updates the quality section of the internationally harmonized Common Technical Document (CTD), a standardized format used by industry and regulators worldwide to compile pharmaceutical registration dossiers. The revisions reflect work under the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and are intended to enhance efficiency in registration and lifecycle management while facilitating digitalization and structured knowledge management.

By providing a clearer and more consistent framework for quality data in Modules 2.3 and Module 3 of the CTD, the guidance aims to streamline regulatory reviews and reduce redundancy in submissions. It also supports the adoption of emerging technologies and helps align expectations across global regulatory authorities, potentially speeding patient access to safe and effective medicines.

The draft guidance is open for public comment through March 23, 2026. Stakeholders are encouraged to submit feedback to ensure the FDA considers industry and public input before finalizing the document.