Regulations on the Administration of Reporting Serious Adverse Events in Vaccine Clinical Trials (Trial)
Request Regulations on the Administration of Reporting Serious Adverse Events in Vaccine Clinical Trials (Trial)
  • Local Title:疫苗临床试验严重不良事件报告管理规定(试行)
  • Country/Region:Chinese Mainland
  • Competent Authority: Former China Food and Drug Administration (CFDA)
  • Type:Regulation
  • Status:In force
  • Release Date:2014-01-17
  • Implementation Date:2014-01-17
Document
Language Source Title Access
ZH Official 疫苗临床试验严重不良事件报告管理规定(试行) Download
Summary

The Regulations on the Administration of Reporting Serious Adverse Events in Vaccine Clinical Trials (Trial) was issued on Jan.17, 2014. It aims to further strengthen the safety risk management of vaccine clinical trials and strengthen the safety of subjects, which includes relevant policies, regulations, and measures.