China Issues New Drug MAH Responsibility Requirements

Starting on March 1st, 2023, China’s Provisions on the Supervision and Administration of Drug Market Authorization Holder Implementation of the Main Responsibilities of Drug Quality Safety, was implemented. The goal of these provisions is to require drug market authorization holders (MAHs) to set up a quality management system for drug manufacturing, development, sales, etc. In the provisions, the drug MAH must create a separate quality management department. This quality department must have at least four key people, including someone in charge to oversee all activities and separate people in control of drug manufacturing, drug quality, and the release of the drug.

Responsibilities of the quality management group include things like drug traceability, screening suppliers, etc. In addition, the MAH must act in accordance with annual reports, GMP, pharmacovigilance, etc.