Good Laboratory Practice (GLP) for Drugs
Request Good Laboratory Practice (GLP) for Drugs
  • Local Title:药物非临床研究质量管理规范
  • Country/Region:Chinese Mainland
  • Competent Authority: Former China Food and Drug Administration (CFDA)
  • Type:Regulation
  • Status:In force
  • Release Date:2017-07-27
  • Implementation Date:2017-09-01
Document
Language Source Title Access
ZH Official 药物非临床研究质量管理规范 Download
Summary

China's GLP applies to the non-clinical safety evaluation studies for drug registration application. 

Contents:

Chapter I: General Provisions

Chapter II: Glossary and Definition

Chapter III: Organization and Personnel

Chapter IV: Facility

Chapter V: Equipment and Experimental Material

Chapter VI: Experimental System

Chapter VII: Standard Operation Procedure

Chapter VIII: Inplementation of Study

Chapter IX: Quality Assurance

Chapter X: Document and Archive

Chapter XI: Entrustor

Chapter XII: Supplementary Provisions