Regulations on Quality Management for Drug Non-clinical Research
Request Regulations on Quality Management for Drug Non-clinical Research
  • 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
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ZH Official 药物非临床研究质量管理规范 Download
Summary

The  was issued on Jul.27, 2017. It aims to ensure theRegulations on Quality Management for Drug Non-clinical Research quality of non-clinical safety evaluation of drugs and ensure the safety of public drug use, which includes:

Chapter 1 General Provisions

Chapter 2 Terms and Definitions

Chapter 3 Organization and Personnel

Chapter 4 Facility

Chapter 5 Instruments and Experimental Materials

Chapter 6 Experimental System

Chapter 7 Standard Operating Procedure

Chapter 8 Implementation of Research Work

Chapter 9 Quality Assurance

Chapter 10 Data File

Chapter 11 Entrusting Party

Chapter 12 Supplementary Provisions