文档介绍：DRUG REGISTRATION REGULATION
May 1,2005-Effective
(Translation by RDPAC, for Member use only)
Chapter 1: General Principles 1
Chapter 2: Application for Drug Registration 2
Chapter 3: Pre-clinical Laboratory Study of Drugs 3
Chapter 4: Clinical Study of Drugs 5
Chapter 5: Application and Approval of New Drugs 9
Chapter 6: Application and Approval of Drugs Already withNational Standards 14
Chapter 7: Application and Approval for Import Drugs 15
Chapter 8: Application and Approval for OTC Drugs 18
Chapter 9: Supplemental Application for Drug Registration 19
Chapter 10: Re-registration of Drugs 20
Chapter 11: Administration of Drug Inspection for Registration 21
Chapter 12: Administration of Drug Registration Standards 22
Standard Substance 24
Chapter 13: Drug Registration Prescribed Timeline 25
Chapter 14: Reconsideration 28
Chapter 15: Legal Liability 28
Chapter 16: Miscellaneous 29
Annex 1: Registration Categories and Application Information Requirements of TCM and Natural Drugs 31
Annex 2: Registration Categories and Application Information Requirements of Chemical Drugs 32
Annex 3: Registration Categories and Application Information Items Requirements of Biological Products 48
Annex 4: Registration Items and Application Information Requirements of Supplemental Application of Drug Registration 68
Annex 5: Application Information Items of Drug Re-Registration
80
Chapter 1: General Principles
Article 1: This Regulation is promulgated according to the Drug Administration Law of The People’s Republic of China (Drug Administration Law) and the Implementing Regulation of the Drug Administration Law of The People’s Republic of China (Implementing Regulation) to ensure the safety, efficacy and quality control of drugs and standardize drug registration.
Article 2: This Regulation shall apply to all drug research and clinical studies, application for clinical study, drug production or importation, as well as the related drug registration inspect