-
NMPA Issued 7 Guidelines for Technical Review of the Registration of Colloidal Gold Immunochromatographic Analyzer
2020-03-05
NMPA has organized the formulation of and released on March 5, 2020 the Guidelines for Technical Review of the Registration of Colloidal Gold Immunochromatographic Analyzers, Guidelines for Technical Review of the Registration of Folliclestimulating Hormone Detection Reagents, Guidelines for Technical Review of the Registration of Creatinine Detection Reagents, Guidelines for Technical Review of the Registration of Antinuclear Antibody Detection Reagents, Guidelines for Technical Review of the Registration of Antithyroid Peroxidase Antibody Assay Reagents, Guidelines for Technical Review of the Registration of Glycated Albumin Assay Reagents, and the Guidelines for Technical Review of the Registration of Total Bile Acid Assay Reagents.
-
NMPA Issued the Announcement on 6 Industry Standards Including Protective devices against diagnostic medical X-radiation – Part 1: Determine of attenuation properties of materials
2020-03-02
On March 5, 2020, NMPA issued the Announcement on 6 Industry Standards Including Medical Diagnostic X-Ray Radiation Protective Devices-Part 1: Determination of Material Attenuation Performance.
-
Announcement of NMPA on Applying 11 ICH Guidelines Including Q2 (R1): Validation of Analytical Procedures: Text and Methodology
2020-01-22
NMPA has decided to apply 11 ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines, including the Q2(R1): Validation of Analytical Procedures: Text and Methodology.
-
Announcement of NMPA on Recommended Application of 4 ICH Guidelines Including Q8 (R2): Pharmaceutical Development
2020-01-22
On January 21, 2020, NMPA issued a notice on recommending the application of ICH Guideline Q8 (R2): Pharmaceutical Development.
-
Announcement of NMPA on Revising the Package Inserts of Drugs Containing Pipemidic Acid
2020-01-21
NMPA issued an announcement with decisions made to revise the [adverse reactions], [precautions] and other Entries on the package inserts of drugs containing pipemidic acid (including pipemidic acid tablets, capsules, and granules).
-
Medical Device Unique Identification Database Goes Online
2019-12-10
In the next step, NMPA will strengthen guidance and services for the application of unique identification data for medical devices,and open the unique identification database query and sharing services to the pilot units in March 2020 in accordance with the pilot work deployments.
