Work Procedures for the Review of Drugs for Conditional Approval (Trial)
Request Work Procedures for the Review of Drugs for Conditional Approval (Trial)
  • Local Title:药品附条件批准上市申请审评审批工作程序(试行)
  • Country/Region:Chinese Mainland
  • Competent Authority: National Medical Products Administration (NMPA)
  • Type:Regulation
  • Status:In force
  • Release Date:2020-07-08
  • Implementation Date:2020-07-08
Document
Language Source Title Access
ZH Official Work Procedures for the Review of Drugs for Conditional Approval (Trial) Download
Summary

Conditional Approval (CA) is one of the four expedited programs for drug registration in China. The document introduces the qualification for applying for CA and the review process of the applications.