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NMPA Announcement on Revising the Package Inserts of 14 Drug Varieties Including Paracetamol, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution
2021-04-21
In order to further protect the medication safety for the public, NMPA decided to revise the package inserts of 14 drug varieties.
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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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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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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.
