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NMPA Announcement on Issuing the Guidance for Preparation of Contract Production Quality Agreement of Medical Devices
2022-03-24
The National Medical Products Administration organized to revise the Guidance for Preparation of Contract Manufacturing Quality Agreement of Medical Devices, which was issued on March 22, 2022.
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Notice of the National Center for ADR Monitoring Center of NMPA on Issuing the Guidance for the Preparation of Master Files of Pharmacovigilance System
2022-02-25
The National Center for ADR Monitoring has formulated the Guidance for the Preparation of Master Files of Pharmacovigilance System in accordance with the requirements of the National Medical Products Administration, which was issued on February 25, 2022.
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Announcement of the Center for Drug Evaluation of NMPA on Issuing the Technical Guidance for Clinical Trials of New Antiviral Drugs for COVID-19 (Interim)
2022-02-17
In order to guide the scientific research, development and evaluation of antiviral drugs for COVID-19 and provide technical standards for reference, the CDE has formulated the Technical Guidance for Clinical Trials of New Antiviral Drugs for COVID-19 (Interim).
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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.
