Drug Registration Regulation (New)
The Drug Registration Regulation has been deliberated and approved by the first 2020
Administration Affair Meeting of the State Administration for Market Regulation on January 15,
2020. It is hereby promulgated and shall come into force from July 1, 2020.
Director Xiao Yaqing
January 22, 2020
Drug Registration Regulation
(Promulgated by Decree No. 27 of the State Administration for Market Regulation on January 22, 2020.There are total 126 Articles in 10 Chapters.)
Chapter I General Provisions
Chapter II Basic Systems and Requirements
Chapter III Drug Marketing Registration
Chapter II Basic Systems and Requirements
Chapter III Drug Marketing Registration
Section I Drug Clinical Trials
Section II Drug Marketing Authorization
Section III Bundling Review and Approval
Section IV Drug Registration Inspection
Section V Drug Registration Testing
Chapter IV Accelerated Drug Marketing Registration Procedures
Section I Breakthrough Therapy Drug Procedure
The Regulation shall be implemented from July 1, 2020. The Drug Registration
Section II Drug Marketing Authorization
Section III Bundling Review and Approval
Section IV Drug Registration Inspection
Section V Drug Registration Testing
Chapter IV Accelerated Drug Marketing Registration Procedures
Section I Breakthrough Therapy Drug Procedure
Section II Conditional Approval Procedure
Section III Priority Review and Approval Procedure
Section IV Special Review and Approval Procedure
Chapter V Post-marketing Changes and Renewal of Drugs
Section I Post-marketing Studies and Changes of Drugs
Section II Drug Renewal
Chapter VI Acceptance, Withdrawal of Application, Decision of Review and Dispute
Resolution
Chapter VII Working Timeline
Chapter VIII Supervision and Administration
Chapter IX Legal Liabilities
Chapter X Supplementary Provisions
The Regulation shall be implemented from July 1, 2020. The Drug Registration
Regulation issued by the former State Food and Drug Administration on July 10, 2007 shall be
repealed at the same time.
