Provisions for Drug Registration
Request Provisions for Drug Registration
  • Local Title:药品注册管理办法
  • Country/Region:Chinese Mainland
  • Competent Authority: State Administration for Market Regulation (SAMR)
  • Type:Regulation
  • Status:In force
  • Release Date:2020-01-22
  • Implementation Date:2020-07-01
Language Source Title Access
ZH Official 药品注册管理办法 Download
EN Official Provisions for Drug Registration Download

The Provisions for Drug Registration, adopted at the first executive meeting of the State Administration for Market Regulation on Jan. 15, 2020, was promulgated and came into force on July 1, 2020. The Provisions covers drug clinical trials, marketing authorization, bundling review and approval, registration inspection, registration testing, accelerated drug marketing registration procedures, post-marketing changes, registration renewal, acceptance and withdrawal of application, decision of review and dispute resolution, working timeline, supervision and administration, as well as legal liabilities.