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NMPA Notice on Issuing the Guidance for Compiling the Product Technical Requirements for Medical Devices
2022-02-09
The National Medical Products Administration has organized the revision of the Guidance for Compiling the Product Technical Requirements for Medical Devices, which was issued on February 8, 2022.
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NMPA Announcement on Issuing Six Registration Technical Review Guidelines on Products such as Disposable High Pressure Contrast Syringes and Accessories
2022-01-17
The National Medical Products Administration formulated the Guidance for the Registration Review of Disposable High Pressure Contrast Syringes and Accessories, Guidance for the Registration Review of Internal Fixation System Products of Metal Plates (2021 Revision), Guidance for Registration Review of Magnesium Orthopaedic Implants, Guidance for the Registration Review of Microcatheters, Guidance for the Registration Review of Disposable Endoscopic Injection Needles, and Guidance for the Registration Review of Intraocular Lens.
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NMPA Announcement on Further Strengthening the Administration of Radioactive Pharmaceuticals
2022-01-14
In order to further strengthen the manufacturing management of radioactive pharmaceuticals and ensure their quality, safety and effectiveness, in accordance with the Drug Administration Law, Provisions for the Administration of Radioactive Pharmaceuticals and other laws and regulations, the relevant issues are hereby announced as follows on January 13, 2022.
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NMPA Announcement on Issuing the Catalogue of Reference Preparations of Generic Drugs (Fiftieth Batch)
2022-01-11
On January 7, 2022, the NMPA issued the Catalogue of Reference Preparations of Generic Drugs (Fiftieth Batch), which has been reviewed and determined by the NMPA Experts Committee of Quality and Efficacy Consistency Evaluation of Generic Drugs.
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NMPA Announcement on Two Guidelines for Registration Review of Drug-Device Combination Products with Device Taking Primary Mode of Action
2022-01-17
National Medical Products Administration has set the technical evaluation of drug-device combination products as a research project in regulatory science, and organized to formulate the Guideline for Registration Review Drug-Device Combination Products with Device Taking Primary Mode of Action and the Guideline for Registration Review of Qualitative, Quantitative and In Vitro Release Studies of Drugs in Drug-Device Combination Products with Device Taking Primary Mode of Action.
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NMPA Announcement on the Technical Guideline for the Revision of Safety Information Items in Package Inserts of Marketed Traditional Chinese Medicines (Interim)
2022-01-07
NMPA organized to formulate the Technical Guideline for the Revision of Safety Information Items in Package Inserts of Marketed Traditional Chinese Medicines (Interim), which was issued on January 4, 2022.
