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NMPA Announcement on Issuing the Good Pharmacovigilance Practice
2021-05-13
NMPA has organized to formulate the Good Pharmacovigilance Practice to standardize and guide drug marketing authorization holders and drug registration applicants to conduct pharmacovigilance activities.
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NMPA Announcement on the Applicability of ICH Guidelines M9: Biopharmaceutics Classification System-based Biowaivers and Q&A Document thereof and Q5D Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products
2021-05-07
In order to promote the technical standards of drug registration in line with international standards, upon study, NMPA decided to apply the ICH Guidelines M9 Biopharmaceutics Classification System-based Biowaivers and Q&A document thereof and Q5D Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products.
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NMPA CDE Announcement on Issuing the Guidance for Clinical Trials of Biosimilars of Tocilizumab Injection
2021-04-21
CDE has organized to formulate the Guidance for Clinical Trials of Biosimilars of Tocilizumab 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 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 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.