Chinese NMPA Released the National Medical Products Newsletter

In January 2021 the Chinese NMPA published 2021 Volume I of the National Medical Products Newsletter.

The newly released NMPA newsletter reported some important NMPA announcements including:

  • Center for Drug Evaluation of NMPA Announced on Issuing the Administrative Measures for Communication of Drug R&D and Technical Review
  • SAMR (State Administration for Market Regulation) Released the Provisions for the Lot Release of Biological Products
  • NMPA Announcement on Issues Pertaining to Online Application for Drug Registration Affairs
  • NMPA Announcement on Issuing the Provisions for the Change Management of Post-approval Drugs (Interim)
  • NMPA Announcement on the Application of ICH Guideline E9 (R1): Estimands and Sensitivity Analysis in Clinical Trials
  • NMPA Announcement on Issuing the Catalogue of Medical Devices Exempt from Clinical Trials (Revised Second Batch)
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