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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).
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2019 Drug Review Annual Report Is Released
2020-07-30
On July 30, 2020, the Center for Drug Evaluation released the 2019 Drug Review Annual Report, some contents of which are summarized as follows.
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NMPA Issues the Opinions on Reinforcing ADR Monitoring & Evaluation System and Capacity Building
2020-07-30
On July 30, 2020, NMPA issued the Opinions on Reinforcing ADR Monitoring & Evaluation System and Capacity Building.
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NMPA Issued 7 Guidances for Technical Review Including the Guidance for Technical Review of the Registration of Vertebroplasty Balloon Dilation Catheters
2020-05-07
To strengthen the supervision and guidance over medical device product registration and further improve the quality of registration review, NMPA has organized the formulation of the Guidances, which have been released on May 9, 2020.
