Measures for Adverse Drug Reaction Reporting and Monitoring Administration
Request Measures for Adverse Drug Reaction Reporting and Monitoring Administration
  • Local Title:药品不良反应报告和监测管理办法
  • Country/Region:Chinese Mainland
  • Competent Authority: Former Ministry of Health
  • Type:Regulation
  • Status:In force
  • Release Date:2011-05-04
  • Implementation Date:2011-07-01
Document
Language Source Title Access
ZH Official 药品不良反应报告和监测管理办法 Download
Summary

The Measures for Adverse Drug Reaction Reporting and Monitoring Administration was passed by Former Ministry of Health on May. 4, 2011, ans took effect on Jul. 1, 2022. It applies to the reporting, monitoring, supervision and administration of adverse drug reactions within the territory of the People's Republic of China.

Chapter I General Provisions 

Chapter ll Duties

Chapter lll Reporting and Handling 

Chapter IV Intensive Medicines Monitoring 

Chapter V Assessment and Control 

Chapter VI Information Management 

Chapter Vll Legal Responsibility 

Chapter Vll Supplementary Provisions