Good Clinical Practice (GCP) for Drugs
Request Good Clinical Practice (GCP) for Drugs
  • Local Title:药物临床试验质量管理规范
  • Country/Region:Chinese Mainland
  • Competent Authority: National Medical Products Administration (NMPA);  National Healthcare Commission (NHC)
  • Type:Regulation
  • Status:In force
  • Release Date:2020-04-26
  • Implementation Date:2020-07-01
Document
Language Source Title Access
ZH Official 药物临床试验质量管理规范 Download
Summary

China's GCP, first issued in 2003 and revised in 2020, is quality standards for the whole process of drug clinical trials. 

Contents:

   Chapter I: General Provisions

   Chapter II: Glossary and Definition

   Chapter III: Ethnics Committee

   Chapter IV: Investigator

   Chapter V: Applicant

   Chapter VI: Trial Protocol

   Chapter VII: Investigator's Brochure

   Chapter VIII: Management of Essential Documents

   Chapter IX: Supplementary Provisions