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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.
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NMPA Issued the Fundamental Principles for Medical Device Safety and Performance
2020-03-10
NMPA has organized the formulation of and released on March 10, 2020 the Fundamental Principles for Medical Device Safety and Performance.
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NMPA Issued 2 Guidelines for Technical Review of the Registration of X-ray Image Guided Systems for Radiotherapy and Positron Emission / X-Ray Computed Tomography Systems
2020-03-10
NMPA has organized the formulation of and released on March 10, 2020 the Guidelines for Technical Review of the Registration of X-ray Image Guided Systems for Radiotherapy and Guidelines for Technical Review of the Registration of Positron Emission / X-Ray Computed Tomography Systems.
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SFDA Issued the Guidelines for Technical Review of the Registration of Implantable Left Ventricular Assist System
2020-03-10
NMPA has organized the formulation of and released on March 10, 2020 the Guidelines for Technical Review of the Registration of Implantable Left Ventricular Assist System.
