-
NMPA Announcement on Further Strengthening the Supervision and Administration of Entrusted Manufacturing by Registrants of Medical Devices (No.38, 2024)
2024-04-03
Pursuant to the implementation of the Regulations for the Supervision and Administration of Medical Devices, and with the objective of fully enforcing the primary responsibility for quality and safety on the part of the registrant of medical devices (hereinafter referred to as “Registrant”), this announcement aims to further strengthen the supervision and administration of entrusted manufacturing by registrants of medical devices, and enable effective prevention and control of quality and safety risks associated with medical devices.
-
NMPA Announcement on Issuing the Procedures for Assessment of Drug Control Institutions of Technetium-Labeled and Positron Radioactive Pharmaceuticals (No. 21 of 2024)
2024-03-14
The NMPA organized to formulate the Procedures for Assessment of Drug Control Institutions of Technetium-Labeled and Positron Radioactive Pharmaceuticals, which are hereby issued and shall come into force as of the date of issuance. National Institutes for Food and Drug Control shall, as per its duties, guide the construction of relevant control institutions.
-
NMPA Announcement on Adopting ICH Guidelines M10 Q&As and FAQs
2023-07-04
To align the technical standards for drug registration with international standards, the NMPA upon deliberation decided to adopt the ICH(International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) Guidelines M10: Bioanalytical Method Validation And Study Sample Analysis (hereinafter referred to as M10) Q&As documents and FAQs documents.
-
Special Provisions for TCM Registration released
2023-02-10
On Feb 10, the Special Provisions for Traditional Chinese Medicines Registration (hereinafter referred to as the Special Provisions) is issued by China NMPA and will take effect on July 1, 2023.
-
Provisions for Supervision and Administration of Online Drug Sales
2022-12-29
Promulgated by Decree No. 58 of the State Administration for Market Regulation on August 3, 2022, these Provisions shall go into effect as of December 1, 2022.