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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.
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Notice of CDE of China NPMA on Issuing the Technical Guidance for Studies of Dermatological Generic Drugs for Topical Use (Interim)
2021-03-16
The CDE, under the guidance of NMPA, has organized to formulate the Technical Guidance for Studies of Dermatological Generic Drugs for Topical Use (Interim), which was issued and implemented as of March 3.