-
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.
-
NMPA Announcement on Issuing the Catalogue of Used Cosmetic Raw Materials (Edition 2021)
2021-04-30
NMPA has organized the revisions to the Directory of Used Cosmetic Raw Materials (Edition 2015) and formed the Catalogue of Used Cosmetic Raw Materials (Edition 2021), which was issued on April 27, and takes effect as of May 1, 2021.
-
NMPA Announcement on Issuing the Working Procedures for the Administration of Supplementary Test Methods of Cosmetics and the Technical Guidelines for the Study and Drafting of Supplementary Test Methods of Cosmetics
2021-04-28
The Working Procedures for the Administration of Supplementary Test Methods of Cosmetics and the Technical Guidelines for the Study and Drafting of Supplementary Test Methods of Cosmetics were issued on April 23 in accordance with the Regulations for the Supervision and Administration of Cosmetics.
-
Announcement on Issuing the Technical Guidelines for Submitting Registration and Notification Dossier of Cosmetics (Interim)
2021-04-25
NMPA has organized to formulate the Technical Guidelines for Submitting Registration and Notification Dossier of Cosmetics (Interim), which was issued on April 12.
-
NMPA Announcement on Revising the Package Inserts of 14 Drug Varieties Including Paracetamol, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution
2021-04-21
In order to further protect the medication safety for the public, NMPA decided to revise the package inserts of 14 drug varieties.
-
NMPA Announcement on Issuing 5 Technical Review Guidances for Registration
2021-04-15
To strengthen the supervision and guidance of medical device registration and further improve the quality of registration review, NMPA has organized to formulate the following guidances, which were issued on April 7.