Regulation on Drug Registration

(Draft)

Table of Contents

Chapter 1 General Provisons

Chapter 2 Basic Systems and Requirements

Chapter 3 Marketing Registration of Drugs

Section 1 Clinical Trials of Drugs

Section 2 Drug Marketing Authorization

Section 3 Associated Review Approval

Section 4 Drug Registration Verification

Section 5 Drug Registration Inspection

Chapter 4 Expedited Marketing Registration of Drugs

Section 1 Breakthrough Therapeutic Drug Procedure

Section 2 Conditional Approval Procedure

Section 3 Priority Review and Approval Procedure

Section 4 Special Approval Procedure

Chapter 5 Post-Marketing Changes and Re-Registration of Drugs

Section 1 Post-Marketing Research and Changes of Drugs

Section 2 Re-Registration of Drugs

Chapter 6 Acceptance, Supplementary Information and Withdrawal

Chapter 7 Working Time

Chapter 8 Supervision and Management

Chapter 9 Legal Liabilities

Chapter 10 Supplementary Provisions

Chapter 1 General Provisions

Article 1 [Legal basis] This Regulation is hereby promulgated to standardize drug registration actions and ensure the safety, efficacy and quality control of drugs in accordance with the Drug Administration Law of the People’s Republic of China (hereinafter referred to as the Drug Administration Law), Chinese Medicine Act, Law of the People’s Republic of China on Vaccine Administration (hereinafter referred to as the Vaccine Administration Law), Administrative Licensing Law of the People’s Republic of China, and Implementing Regulation of the Drug Administration Law of the People’s Republic of China.

Article 2 [Scope of application] This Regulation should apply to all enterprises engaging in drug research and registration, as well as supervision and administration of drugs for marketing in the People’s Republic of China.

Article 3 [Definition of drug registration] Drug registration refers to the process by which a decision is made by the drug administration upon application and supplementary application for drug clinical trials, drug marketing authorization, and re-registration by the applicant of drug registration (hereinafter referred to as the Applicant) according to legal procedures and other relevant requirements, to either approve or reject the application and perform management of the related records or reporting items based on safety, efficacy and quality control reviews while referring to the laws and regulations and existing scientific cognition.

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