News

The approval of Isobutylamido Thiazolyl Resorcinol demonstrates China’s commitment to balancing innovation with consumer safety…|The approval of Isobutylamido Thiazolyl Resorcinol demonstrates China’s commitment to balancing innovation with consumer safety…

The national standard "Diagnostic Techniques for Equine Rhinopneumonitis" has been published and is set to be implemented on June 1, 2025.|The national standard "Diagnostic Techniques for Equine Rhinopneumonitis" has been published and is set to be implemented on June 1, 2025.

The national standard titled "Diagnostic Techniques for Canine Distemper" has been published and is set to come into effect on June 1, 2025.|The national standard titled "Diagnostic Techniques for Canine Distemper" has been published and is set to come into effect on June 1, 2025.

On October 21, 2024, the NMPA of China provided an overview of the current status of pediatric IVD reagents in the country, highlighting...|On October 21, 2024, the NMPA of China provided an overview of the current status of pediatric IVD reagents in the country, highlighting...

The NMPA has released a draft of the ‘Good Manufacturing Practices for Medical Devices’, which is now open for public comment...|The NMPA has released a draft of the ‘Good Manufacturing Practices for Medical Devices’, which is now open for public comment...

On October 23, 2024, Cisema’s regulatory specialist Miriam Bandinelli shared valuable insights concerning China’s cosmetics market...

China water efficiency label updated on Nozzle implementation rules have been published by the National Development and Reform Commission, effective from January 1, 2025|China water efficiency label updated on Nozzle implementation rules have been published by the National Development and Reform Commission, effective from January 1, 2025

2024 IVD Reagents Clinical Trial Exemption Catalog draft has been announced by the CMDE on November 4, 2024, and opened for public consultation|2024 IVD Reagents Clinical Trial Exemption Catalog draft has been announced by the CMDE on November 4, 2024, and opened for public consultation

China priority acceptance service for innovative drugs marketing applications has been introduced by the CDE on October 24, 2024, and it came into effective from November 1, 2024.|China priority acceptance service for innovative drugs marketing applications has been introduced by the CDE on October 24, 2024, and it came into effective from November 1, 2024.

China’s NMPA has announced Interim regulations on the Administration of Designated Domestic Responsible Person for Foreign Drug Marketing License Holders|China’s NMPA has announced Interim regulations on the Administration of Designated Domestic Responsible Person for Foreign Drug Marketing License Holders

China domestic production of imported medical devices policy has been drafted and released by the National Medical Products Administration (NMPA) on November 4 ,2024.|China domestic production of imported medical devices policy has been drafted and released by the National Medical Products Administration (NMPA) on November 4 ,2024.

China medical device industry standards were issued by the National Medical Products Administration in July 2024.|China medical device industry standards were issued by the National Medical Products Administration in July 2024.

China cosmetics adverse reactions self-investigation report writing guidelines have been drafted and announced by the National Center for ADR Monitoring on November 8, 2024.|China cosmetics adverse reactions self-investigation report writing guidelines have been drafted and announced by the National Center for ADR Monitoring on November 8, 2024.

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.