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NMPA CDE Announcement on Issuing the Guidance for Clinical Trials of Biosimilars of Pertuzumab Injection
2021-04-21
CDE has organized to formulate the Guidance for Clinical Trials of Biosimilars of Pertuzumab Injection, which was issued for implementation on April 21 upon review and approval by NMPA.
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NMPA CDE Announcement on Issuing the Guidance for Real-World Data Used to Generate Real-World Evidences (Interim)
2021-04-13
The CDE has organized to formulate the Guidance for Real-World Data Used to Generate Real-World Evidences (Interim), which was issued for implementation on April 13 upon review and approval by NMPA.
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NMPA Announcement on Issuing the Technical Guidance for the Safety Evaluation of Cosmetics (2021 Edition)
2021-04-09
The NMPA has organized to formulate the Technical Guidance for the Safety Evaluation of Cosmetics (2021 Edition), which was issued on April 8 and shall take effect as of May 1, 2021.
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Notice of CDE of China NMPA on Issuing the Technical Guidance for Immunogenicity Studies of Drugs
2021-03-30
The CDE, under the guidance of NMPA, has organized to formulate the Technical Guidance for Immunogenicity Studies of Drugs, which was issued and implemented as of March 5.
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National Annual Report for Medical Device Adverse Event Monitoring (2020)
2021-03-29
In 2020, the National Medical Device Adverse Event Monitoring Information System has received a total of 536,055 reports of medical device adverse events, showing an increase of 35.25% compared with the previous year.
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Annual Report for National Adverse Drug Reaction Monitoring (2020)
2021-03-26
In 2020, the China National ADR Monitoring Network received 1.676 million copies of ADR/ADE Reports.