The Regulations on the Implementation of Provisions on the Supervision and Administration of the Main Responsibility for Drug Quality and Safety of Holders of the Drug Marketing Authorization was issued on Dec.29, 2022. It aims to make drug marketing authorization holders take the main responsibility for the implementation of the drug quality and safety, which includes:
Chapter 1 General Provisions
Chapter 2 Key Responsibilities and Requirements of Holders
Chapter 3 Requirements of Quality Management of Holders
Chapter 4 Quality Management Mechanism of Holders
Chapter 5 Supervision and Administration
Chapter 6 Supplementary Provisions