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NMPA Announcement on Issuing the Catalogue of Medical Devices Exempt from Clinical Trials (Revised Second Batch)
2021-01-19
NMPA issued the Announcement on the Issuance of the New and Revised Catalogues of Medical Devices Exempt from Clinical Trials, and published the first batch of New and Revised Catalogues of Medical Devices (and in vitro diagnostic reagents) Exempt from Clinical Trials.
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NMPA Announcement on the Cancellation of Registration Certificates for Phenolphthalein Tablets and Phenolphthalein Buccal Tablets
2021-01-14
The NMPA therefore decided the immediate cessation of production, sales and use of the two drugs in China with their registration certificates (drug approval number) revoked forthright.
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Clinical Technical Requirements for Drugs Marketed Overseas but Not Marketed in China
2020-11-18
CDE issued the Clinical Technical Requirements for Drugs Marketed Overseas but Not Marketed in China on October 9, 2020.
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Center for Drug Evaluation issued the Technical Guidance for Real-World Study Supporting Research & Development and Evaluation of Pediatric Drugs (Interim)
2020-09-01
CDE issued the Technical Guidance for Real-World Study Supporting Research & Development and Evaluation of Pediatric Drugs (Interim) on August 27, 2020, which shall come into force as of the date of issuance.
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Center for Drug Evaluation issued 5 guidances including the Technical Guidance for Research & Development of Prophylactic Vaccines for Novel Coronavirus (Interim)
2020-08-04
The Center for Drug Evaluation issued 5 guidances including the Technical Guidance for Research & Development of Prophylactic Vaccines for Novel Coronavirus (Interim).
