Regulatory News from Across Asia-Pacific

China non-compliant cosmetics have been announced by the National Medical Products Administration (NMPA) in October 2024.|China non-compliant cosmetics have been announced by the National Medical Products Administration (NMPA) in October 2024.

Stay ahead of the curve with Cisema’s 2025 events; your go-to resource for seminars, webinars, trade fairs, and exhibitions featuring....|Stay ahead of the curve with Cisema’s 2025 events; your go-to resource for seminars, webinars, trade fairs, and exhibitions featuring....

China rare disease drugs clinical pharmacology research technical guidelines have been drafted for comments by the CDE on October 12, 2024.

GBA Connect Scheme has approved 79 medical products—39 pharmaceuticals and 40 devices—benefiting ~10,000 GBA patients as of October 9, 2024.

Hong Kong 2024 Policy Address: Key regulatory updates on medical product approvals and initiatives to enhance biomedical research.

China Veterinary Diagnostic Techniques for bovine and caprine paramyxovirus 4 infection have been released.

China NMPA Cosmetics Suspension involves two products from Catalysis, Spain, illustrating the stringent regulations about banned substances.

China innovative medical devices special review results have been announced by the NMPA on October 18, 2024.

China pediatric drugs encouraged for R&D – fifth batch have been announced by the NHC and other 3 organizations on August 30, 2024.

China NMPA has announced a suspension of import, sale and use of laser surgery equipment manufactured by Jeisys Medical Inc.

China Fire Safety Products Compulsory Certification rules were revised and released by the National Certification and Accreditation.

Micro-volume syringe priority review application has been announced by the Center for Medical Device Evaluation on October 18, 2024.

The NHC approved 12 China new food raw materials. This regulatory update outlines safety assessment, production and usage for the substances.

Absorbable hemostatic product and other 11 medical devices registration review guidelines have been revised and published by China's CMDE.

Four new substances were added to the China Health Food Dual-Use Substances Catalogue on August 26, 2024, including Citrus Grandis Tomentosa.

A trial program for the online submission of China drug registration application documents started on July 1, 2024.

The results of China’s latest round of medical device inspection were published by China’s NMPA on 11 September 2024.

InvestHK recently invited Cisema to share regulatory insights at their seminar event, highlighting opportunities in Hong Kong and GBA.

China’s CMDE has published medical device real-world data terms and definitions in draft format for industry comments by October 8, 2024.

China’s NMPA has released a draft Medical Device Administration Law to replace the current China Medical Device Regulations.