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NMPA Issued the Announcement on the Requirements for Dossiers and Samples for Verification and Inspection of Specifications for Overseas New Drugs Urgently Needed in Clinical Settings
2019-06-25
NMPA organized the formulation of the Requirements for Dossiers and Samples for Verification and Inspection of Specifications for Overseas New Drugs Urgently Needed in Clinical Settings (Chemicals) and the Requirements for Dossiers and Samples for Verification and Inspection of Specifications for Overseas New Drugs Urgently Needed in Clinical Settings (Biologicals).
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NMPA Promulgated the Guidelines for Clinical Safety Literature Evaluation of Marketed Drugs (Interim)
2019-06-18
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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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
2019-06-11
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.
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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
2019-06-06
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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2018 Annual Report for Medical Device Registration Released
2019-05-31
NMPA issued the 2018 Annual Report for Medical Device Registration on May 31, 2019,which consists of five parts.
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NMPA Issued 27 Medical Device Industry Standards (Covering YY 0096-2019 Co-60 Teletherapy Unit) and 1 Amendment Form
2019-05-31
After review and approval, NMPA published the YY 0096-2019 Co-60 Teletherapy Unit and other 26 medical device industry standards, as well as the No. 1 amendment form for YY 0285.3- 2017 Intravascular catheters—Sterile and single-use catheters—Part 3: Central venous catheters medical device industry standard.