Measures for the Supervision and Management of Drug Production

(Draft)

Table of Contents

Chapter 1 General Provisions

Chapter 2 Production License

Chapter 3 Production Management

Chapter 4 Supervision and Inspection

Chapter 5 Legal Liability

Chapter 6 Supplementary Provisions

Chapter 1 General Provisions

Article 1 [Objective and basis] This Measures for the Supervision and Management of Drug Production is hereby enacted to strengthen drug production supervision and management, and regulate the manufacturing of drugs in accordance with the Drug Administration Law of the People’s Republic of China (hereinafter referred to as the Drug Administration Law), Law of the People's Republic of China on Traditional Chinese Medicine, Law of the People’s Republic of China on Vaccine Administration (hereinafter referred to as the Vaccine Administration Law), Administrative License Law of the People’s Republic of China and the Regulations for Implementation of the Drug Administration Law of the People’s Republic of China.

Article 2 [Scope of application] These measures apply to the production, supervision and management of drugs marketed within the territory of the People's Republic of China.

Article 3 [Drug production requirements] Any enterprise engaging in drug production should comply with laws, regulations, rules, standards and specifications, and ensure that all the information is true, accurate, complete and traceable.

Any enterprise engaging in drug production should be approved by the drug administration at the level of province, autonomous region, and municipality directly under the Central Government, obtain a drug production license and strictly comply with the drug manufacturing quality management specifications, thus ensuring that the productive process meets the legal requirements continuously.

The marketing authorization holder should establish a drug quality assurance system, fulfill the responsibility of releasing drugs on the market, and should be responsible for the quality of drugs with the Drug Registration Certificate.

The manufacturer of TCM decoction pieces should fulfill the relevant obligations of the marketing authorization holder, and ensure that the productive process of TCM decoction pieces could continuously meet the legal requirements.

The manufacturer of active pharmaceutical ingredients should organize production according to the approved process while strictly complying with the drug manufacturing quality management specifications, and ensure that the productive process could continuously meet the legal requirements.

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