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NMPA Announcement on Several Measures to Optimize the Management of Cosmetic Safety Assessment (No. 50, 2024)
2024-04-22
To further optimize the management of cosmetic safety assessment and orderly promote the implementation of the cosmetic safety assessment system, according to the Regulations on Supervision and Administration of Cosmetics, the Provisions for Registration and Notification of Cosmetics and the Technical Guidance for the Safety Evaluation of Cosmetics (2021 Edition) (hereinafter referred to as the Guidance) and other relevant regulatory requirements, the NMPA formulated Several Measures to Optimize the Management of Cosmetic Safety Assessment, which are hereby issued and will come into force from May 1, 2024.
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Announcement on Issuing the Guideline for the Collection and Reporting of Adverse Reactions to Cosmetics by Cosmetic Registrant and Filing Entity (Interim)
2024-04-19
To regulate and guide cosmetic registrants and filing entities to carry out the collection and reporting of adverse reactions to cosmetics, according to the Regulations on Supervision and Administration of Cosmetics, the Provisions for Supervision and Administration of Manufacturing and Marketing of Cosmetics, the Provisions for the Administration of Adverse Reaction Monitoring of Cosmetics and other relevant provisions, in accordance with the requirements of the National Medical Products Administration, the National Center for ADR Monitoring organized to formulate the Guideline for the Collection and Reporting of Adverse Reactions to Cosmetics by Cosmetic Registrant and Filing Entity (Interim), which is hereby issued.
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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.
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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.
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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.
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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.