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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.
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Notice of CDE of China NPMA on Issuing the Technical Guidance for CMC Changes of Innovative Drugs (Chemical Drugs) during Clinical Trials (Interim)
2021-03-15
The CDE, under the guidance of NMPA, has organized to formulate the Technical Guidance for CMC Changes of Innovative Drugs (Chemical Drugs) during Clinical Trials (Interim), which was issued and implemented as of March 3.
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Notice of CDE of China NMPA on Issuing the Technical Requirements for CMC Study and Evaluation of Chemical Drugs Marketed Overseas But Not Marketed in China (Interim)
2021-03-09
The CDE, under the guidance of NMPA, has organized to formulate the Technical Requirements for CMC Study and Evaluation of Chemical Drugs Marketed Overseas But Not Marketed in China (Interim), which was issued and implemented as of March 3.
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NMPA Notice on Issuing the Requirements for Change Items of Marketed Chemicals and Application Dossier
2021-02-10
To cooperate with the implementation of the Provisions for Drug Registration, the NMPA has organized to formulate the Requirements for Change Items of Marketed Chemicals and Application Dossier.
