Guidelines for Pharmacovigilance Testing
Request Guidelines for Pharmacovigilance Testing
  • Local Title:药物警戒检查指导原则
  • Country/Region:Chinese Mainland
  • Competent Authority: National Medical Products Administration (NMPA)
  • Type:Guideline
  • Status:In force
  • Release Date:2022-04-15
  • Implementation Date:2022-04-15
Document
Language Source Title Access
ZH Official 药物警戒检查指导原则 Download
Summary

The Guidelines for Pharmacovigilance Testing was issued on Apr.15, 2022. It aims to implement the requirements of establishing pharmacovigilance system, carry out pharmacovigilance inspection in a scientific and standardized manner, which includes:

1. Key Factors for Routine Inspection

2. Key Considerations for Inspection

3. Inspection Methods

4. Inspection Place

5. Defect Risk Level

6. Evaluation Criteria