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NMPA CDE Announcement on Issuing the Technical Guidance for Quality Control Study of Nano Drugs (interim), Technical Guidance for Non-Clinical Pharmacokinetic Study of Nano Drugs (interim), and Technical Guidance for Non-Clinical Safety Evaluation Study of Nano Drugs (interim)
2021-08-27
The Center for Drug Evaluation has organized to formulate the Technical Guidance for Quality Control Study of Nano Drugs (interim), Technical Guidance for Non-Clinical Pharmacokinetic Study of Nano Drugs (interim), and Technical Guidance for Non-Clinical Safety Evaluation Study of Nano Drugs (interim).
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NMPA Announcement on Issuing the Guidance for Evaluation of the Safety and Efficacy of Medical Devices Using Nano Materials-Part 1: System Framework
2021-08-26
The NMPA has organized to formulate the Guidance for Evaluation of the Safety and Efficacy of Medical Devices Using Nano Materials-Part 1: System Framework, which was issued on August 26, 2021.
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NMPA Announcement on Issuing 2 Guidance including the Guidance for Nomenclature of the Generic Names of Neurosurgical and Cardiovascular Surgical Devices
2021-08-25
The NMPA has organized to formulate the Guidance for Nomenclature for Generic Names of Neurosurgical and Cardiovascular Surgical Devices, and Guidance for Nomenclature for Generic Names of Devices for Medical Diagnosis, Examination and Monitoring, which were issued on August 25, 2021.
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NMPA CDE Announcement on Issuing the Technical Guidance for Clinical Trials of Drugs for the Treatment of Acute Non-Variceal Upper Gastrointestinal Bleeding
2021-08-06
The Center for Drug Evaluation has organized to develop the Technical Guidance for Clinical Trials of Drugs for the Treatment of Acute Non-Variceal Upper Gastrointestinal Bleeding under the deployment of the National Medical Products Administration.
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NMPA CDE Announcement on Issuing the Guidance for Immunogenicity Study of Generic Drugs of Low Molecular Weight Heparin (Interim)
2021-08-06
The CDE has organized to develop the Guidance for Immunogenicity Study of Generic Drugs of Low Molecular Weight Heparin (interim) under the deployment of the NMPA.
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NMPA Notice on Matters Concerning the Registration of Drug-device Combination Products
2021-07-27
In accordance with relevant provisions for registration management of drugs and medical devices, matters concerning the registration of drug-device combination products are hereby announced on July 23 as follows.
