-
NMPA Announcement on Issuing the Working Procedures for Dynamic Adjustment of Classification Catalogue for Medical Devices
2021-05-08
NMPA has organized to formulate the Working Procedures for Dynamic Adjustment of Classification Catalogue for Medical Devices, which was issued on April 27.
-
NMPA CDE Announcement on Issuing the Guidance for Clinical Trials of Biosimilars of Tocilizumab Injection
2021-04-21
CDE has organized to formulate the Guidance for Clinical Trials of Biosimilars of Tocilizumab Injection, which was issued for implementation on April 21 upon review and approval by NMPA.
-
NMPA CDE Announcement on Issuing the Guidance for Clinical Trials of Biosimilars of Pertuzumab Injection
2021-04-21
CDE has organized to formulate the Guidance for Clinical Trials of Biosimilars of Pertuzumab Injection, which was issued for implementation on April 21 upon review and approval by NMPA.
-
NMPA CDE Announcement on Issuing the Guidance for Real-World Data Used to Generate Real-World Evidences (Interim)
2021-04-13
The CDE has organized to formulate the Guidance for Real-World Data Used to Generate Real-World Evidences (Interim), which was issued for implementation on April 13 upon review and approval by NMPA.
-
NMPA Announcement on Issuing the Technical Guidance for the Safety Evaluation of Cosmetics (2021 Edition)
2021-04-09
The NMPA has organized to formulate the Technical Guidance for the Safety Evaluation of Cosmetics (2021 Edition), which was issued on April 8 and shall take effect as of May 1, 2021.
-
Notice of CDE of China NMPA on Issuing the Technical Guidance for Immunogenicity Studies of Drugs
2021-03-30
The CDE, under the guidance of NMPA, has organized to formulate the Technical Guidance for Immunogenicity Studies of Drugs, which was issued and implemented as of March 5.