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NMPA Announcement on Adding the Medication Information for Children to the Package Inserts of Haloperidol Tablets and Other Varieties
2021-05-31
In order to better meet the clinical medication needs of children, upon the study and demonstration, package inserts of Haloperidol Tablets and other varieties may be added with the children users and dosage and usage for children according to the requirements.
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NMPA Announcement on the Cancellation of Registration Certificates for 283 Drugs including Megestrol Acetate Dispersible Tablets
2021-05-24
According to the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China and the Provisions for Drug Registration, NMPA has decided to cancel the registration certificate of 283 drugs including Megestrol Acetate Dispersible Tablets.
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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.
