Provisions for Implementation of the Drug Administration Law (Revised Draft)
Request Provisions for Implementation of the Drug Administration Law (Revised Draft)
  • Local Title:中华人民共和国药品管理法实施条例(修订草案征求意见稿)
  • Country/Region:Chinese Mainland
  • Competent Authority: National Medical Products Administration (NMPA)
  • Type:Regulation
  • Status:Draft
  • Release Date:2022-05-09
  • Implementation Date:/
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ZH Official 中华人民共和国药品管理法实施条例 (修订草案征求意见稿) Download
Summary

On May 9, 2022, China National Medical Products Administration (NMPA) released the revised draft of the Provisions for Implementation of the Drug Administration Law for public comments.

The Regulations was first issued with immediate effect in 2002, and was later revised in 2019. Compared to the 2019 version, the draft of the 2022 version includes 101 more articles to conform to the pharmaceutical policy reforms in the recent years and the Drug Administration Law revised in 2019. The new contents involve marketing authorization holder system, patent protection, and pharmacovigilance.

Related: China Encourages Innovative Drug R&D in Revised Draft of Regulations for Implementing the Drug Administration Law

History
2022-05-09
Provisions for Implementation of the Drug Administration Law (Revised Draft)
Draft
Release Date: 2022-05-09
Implementation Date : /
2019-03-02
In force
Release Date: 2019-03-02
Implementation Date : 2019-03-02