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Announcement of NMPA on Revising the Package Inserts of hydrocortisone injection and hydrocortisone sodium succinate for injection
2020-03-17
NMPA issued an Announcement with decisions made to revise the [adverse reactions], [precautions] and other Entries on the package inserts of hydrocortisone injection and hydrocortisone sodium succinate for injection.
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NMPA Issued the 2019 Annual Report for Medical Device Registration
2020-03-17
NMPA issued the 2019 Annual Report for Medical Device Registration, which covers five parts: medical device registration status, medical device registration application acceptance status, medical device registration approval status, innovative medical device registration approval status, and other registration management status.
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Announcement of NMPA on Revising the Package Inserts of Nicotinic Acid Injections
2020-03-17
NMPA issued an Announcement with decisions made to revise the Entries of [contraindications], [adverse reactions] and [precautions] on the package inserts of nicotinic acid injections (including nicotinic acid injection and nicotinic acid for injection).
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Announcement of NMPA on Revising the Package Inserts of Probucol
2020-03-11
NMPA issued an Announcement with decisions made to revise the [adverse reactions], [precautions] and other Entries on the package inserts of probucol.
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NMPA Released Five Informatization Standards Including the Basic Data Set for Traceability of Drug Marketing Authorization Holders and Manufacturers
2020-03-11
NMPA organized the formulation of the Basic Data Sets for Traceability of Drug Marketing Authorization Holders and Manufacturers, Basic Data Sets for Traceability of Drug Distributors, Basic Data Sets for Traceability of Drug Using Units, Basic Data Sets for Traceable Drugs for Consumers, and Basic Technical Requirements for Traceability Data Exchange of Drugs.
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NMPA Issued 4 Guidelines for Technical Review of the Registration of EB Virus Nucleic Acid Detection Reagents
2020-03-10
NMPA has organized the formulation of and released on March 10, 2020 the Guidelines for Technical Review of the Registration of EB Virus Nucleic Acid Detection Reagents, Guidelines for Technical Review of the Registration of HBV e Antigen, e Antibody Detection Reagents, Guidelines for Technical Review of the Registration of Thalassemia-Related Gene Detection Reagents, and Guidelines for Technical Review of the Registration of HBV-Resistant Gene Mutation Detection Reagents.
