Measures for the Administration of Batch Issuance of Biological Products
Request Measures for the Administration of Batch Issuance of Biological Products
  • Local Title:生物制品批签发管理办法
  • Country/Region:Chinese Mainland
  • Competent Authority: State Administration for Market Regulation (SAMR)
  • Type:Regulation
  • Status:In force
  • Release Date:2020-12-11
  • Implementation Date:2021-03-01
Document
Language Source Title Access
ZH Official 生物制品批签发管理办法 Download
Summary

The Measures for the Administration of Batch Issuance of Biological Products was issued on Dec.11, 2020. It aims to strengthen the supervision and management of biological products, standardize the batch issuance behavior of biological products, and ensure the safety and effectiveness of biological products, which includes:

Chapter I General Provisions

Chapter II The Grant Agency

Chapter III Application for Grant

Chapter IV Audit, Inspection, Inspection and Issuance

Chapter V Retrial

Chapter VI Information Disclosure

Chapter VII Legal Liabilitis

Chapter VIII Supplementary Provisions