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NMPA issues announcement on the adoption of 13 ICH safety guidelines (NMPA Announcement No. 89 [2019])
2019-12-19
To align the technical standards for drug registration with international standards, the National Medical Products Administration has decided to adopt 13 ICH safety guidelines, including S1A: Need for Carcinogenicity Studies of Pharmaceuticals.
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NMPA announces adoption of 15 ICH efficacy guidelines (NMPA Announcement No. 88 [2019])
2019-12-19
To align the technical standards for drug registration with international standards, the National Medical Products Administration has decided to adopt 15 ICH efficacy guidelines, including E1: The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-term Treatment of Non-life-threatening Conditions.
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NMPA Promulgated the Technical Guidelines for Clinical Trial of Recombinant Human Coagulation Factor VIII and the Technical Guidelines for Clinical Trial of Recombinant Human Coagulation Factor IX
2019-07-18
NMPA organized the formulation of the Technical Guidelines for Clinical Trial of Recombinant Human Coagulation Factor VIII and the Technical Guidelines for Clinical Trial of Recombinant Human Coagulation Factor IX, which were issued on June 11, 2019.
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NMPA Promulgated the Guidelines for Clinical Safety Literature Evaluation of Marketed Drugs (Interim)
2019-07-18
NMPA organized the formulation of the Guidelines for Clinical Safety Literature Evaluation of Marketed Drugs (Interim), which was issued on June 18, 2019.
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General Office of the State Council Issued the Key Tasks for Deepening the Reform of the Pharmaceutical and Healthcare System in 2019
2019-07-18
Recently, the General Office of the State Council issued the Key Tasks for Deepening the Reform of the Pharmaceutical and Healthcare System in 2019.
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The 2018 Drug Review Annual Report released
2019-07-06
The 2018 Drug Review Annual Report was released on July 1,2019.
