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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.
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NMPA issued the Announcement on Implementing Electronic Application of Medical Device Registration
2019-05-31
NMPA has organized the development of the electronic Regulated Product Submission (eRPS) system, and announced the relevant issues on May 31, 2019.
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NMPA issued the Announcement on Adjusting the Relevant Matters Concerning the Definition of the Attributes of Drug/Device Combination Products
2019-05-31
NMPA issued the Announcement on Adjusting the Relevant Matters Concerning the Definition of the Attributes of Drug/Device Combination Products.