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DRUG REGISTRATION REGULATION
Date:2019-06-13
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General Principles

Application for Drug Registration

Pre-clinical Laboratory Study of Drugs

Clinical Study of Drugs

Application and Approval of New Drugs

Application and Approval of Drugs Already withNational Standards

Application and Approval for Import Drugs

Application and Approval for OTC Drugs

Supplemental Application for Drug Registration

Re-registration of Drugs

Administration of Drug Inspection for Registration

Administration of Drug Registration Standards

Drug Registration Prescribed Timeline

Reconsideration

Le  gal Liability

Miscellaneous

Registration Categories and Application Information Requirements of TCM and Natural Drugs

Registration Categories and Application Information Requirements of Chemical Drugs

Registration Categories and Application Information Items Requirements of Biological Products

Registration Items and Application Information Requirements of Supplemental Application of Drug Registration

Application Information Items of Drug Re-Registration