-
NMPA Announcement on the Issuance of Five Guidelines for Technical Review of the Registration of Human Chromosomal Abnormality Detection Reagents Based on Cytofluorometric In Situ Hybridization and Others
2019-11-15
NMPA has organized the formulation of and released on November 15, 2019 the Guidelines.
-
NMPA Issued the Announcement on Revising the Package Inserts of Prescription and Over-the-counter Oral Preparations such as Huoxuezhitong Capsules
2019-11-08
On November 8, 2019, NMPA issued an Announcement with decisions made to revise the Entries of [warnings], [adverse reactions], [contraindications] and [precautions] of oral preparations (tablets, powders, soft capsules, capsules) such as Huoxuezhitong capsules.
-
NMPA Released Announcement on the Application of 15 ICH Guidelines Including E1: Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions
2019-11-12
On November 12, 2019, NMPA issued the Announcement on the Application of 15 ICH Guidelines Including E1: Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Longterm Treatment of Non-Life-Threatening Conditions.
-
NMPA Released Announcement on the Application of 13 ICH Guidelines Including S1A: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals
2019-11-12
On November 12, 2019, NMPA issued the Announcement on the Application of 13 ICH Guidelines Including S1A: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals.
-
Release of Annual Report for National Medical Device Adverse Event Monitoring (2018)
2019-10-30
To fully reflect the monitoring of adverse events in China's medical devices in 2018, the National Center for Adverse Drug Reaction Monitoring has compiled and released on October 30, 2019 the Annual Report for National Medical Device Adverse Event Monitoring (2018).
-
NMPA Issued Four Guidelines for Technical Review of the Registration of Assay Reagents for Aspartate Aminotransferase and Others
2019-10-29
NMPA has organized the formulation of the Guidelines for Technical Review of the Registration of Assay Reagents for Aspartate Aminotransferase, Guidelines for Technical Review of the Registration of Total Cholesterol Assay Reagents, Guidelines for the Technical Review of Registration of Uric Acid Determination Reagents, and Guidelines for Technical Review of the Registration of Urea Determination Reagents.