Regulatory News from Across Asia-Pacific

China’s NMPA has released revised guidelines on preparing IVD IFU (Instructions for Use) by CMDE on January 3, 2024.

China’s Energy Label Catalogue has been updated. The 16th batch has been released by SAMR and includes 3 new product types requiring CEL.

China’s NMPA has released an update of the Medical Device Standards Catalogue on January 15, 2024. It includes 1974 medical device standards.

Useful information on toothpaste filing in China has been shared by the Beijing MPA in the form of common questions and answers document.

China’s SAMR is proposing an update to its Food Safety Law. It is proposing to include liquid infant formula and is drafted for comments.

China’s Institute of Veterinary Drug Control has released an updated version of the Catalogue of Animal Pathogenic Microorganisms.

China’s NMPA has released a list of 10 new prohibited cosmetic ingredient testing methods on January 8, 2024.

Three new health food ingredients were added to the Catalogue of Health Food Raw Materials and will come into effect on May 1, 2024.

China’s Center for Drug Evaluation has issued updates to the requirements for the electronic submission of drug registration applications.

China’s CDE has issued guidelines to ensure accessibility for drug package inserts. It includes simplified and large-font format requirements.

China new cosmetic ingredients communication channel (Trial) was introduced by the National Institute for Food and Drug Control (NIFDC).

China’s NMPA has issued revised medical device business standards which will come into effect on July 1, 2024.

China’s SAMR has released the regulation for formula food special medical purposes. They will take effect on January 1, 2024.

China drug evaluation report 2022 was released by China’s Center for Drug Evaluation (CDE) in September 2023.

Nine substances were added to the “Catalogue of China health food dual-use substances”, this means they can be used as both food and Chinese Traditional Medicine.

China’s NMPA has released Clobetasol Acetate testing methods to determine any presence and quantity thereof in cosmetic products.

China’s NIFDC is seeking industry comments on new technical guidelines on the definition and research of new cosmetic ingredients.

China’s National Certification and Accreditation Administration has updated standard GB/T 7251 for power switchgear and control gear assemblies.

NMPA conducted China medical device supervision inspections on 11 different categories and announced the sampling results.

Toothpaste filing requirements were released by China’s NMPA on 22 November2023 and come into effect on 1 December 2023