Changes and Reporting Requirements of Listed Biological Products
Request Changes and Reporting Requirements of Listed Biological Products
  • Local Title:已上市生物制品变更事项及申报资料要求
  • Country/Region:Chinese Mainland
  • Competent Authority: National Medical Products Administration (NMPA)
  • Type:Regulation
  • Status:In force
  • Release Date:2021-06-18
  • Implementation Date:2021-06-18
Document
Language Source Title Access
ZH Official 已上市生物制品变更事项及申报资料要求 Download
Summary

The Changes and Reporting Requirements of Listed Biological Products was issued on Jun.18, 2021. It aims to promote the implementation of drug registration management measures, which includes:

1. Supplementary Application Items Approved by the State Drug Regulatory Department

2. National or Provincial Drug Regulatory Authorities Recording Matters

3. Annual Report Items

4. Information Request