Regulatory News from Across Asia-Pacific

China veterinary anesthetic drugs and psychotropic drugs regulations have been published by the Ministry of Agriculture on July 11, 2024.

China Electric Bicycle Battery certification rules CCAP-GZ-464204：2024 have been revised and replace the previous version CCAP-GZ-464204:2023.

CCAP certification of vehicle batteries has revised rules and requirements. These were published by the CCAP China on April 30, 2024.

Post-market changes to Active Pharmaceutical Ingredients in China now have clearer guidance thanks to a recently published Q&A from CDE.

China’s NMPA has issued an update to Radio Frequency Device Requirements in China on July 8, 2024 to ensure the safety.

The NMPA is requesting comments on China drug approvals of Clinically Urgent Overseas Drugs. The deadline to submit comments is July 24, 2024.

China’s NMPA has explored numerous AI use cases in Pharma. The scenarios aim to promote AI research and AI applications in drug regulation.

The China CDE has issued its 2023 Annual Report reviewing the trend in Clinical Trials Applications for New Drug Registrations).

Drug registration in China for transferring Biological Therapeutics products marketed abroad to in China has a clear set of guidelines.

China Car Parts Certification will be issued by China’s Certification Alliance for Vehicles (CAV) for some car parts as of July 1, 2024. The certification process remains the same, however, the issuing body has changed to the CAV.

China compliant cosmetic ingredients now have a set of draft guidelines on how to determine and research their history of safe use.

China compliant cosmetic ingredients now have a set of draft guidelines on how to determine and research their history of safe consumption. They were released by China’s NIFDC on May 31, 2024.

China’s NMPA introduces Measures for the Supervision and Inspection of Medical Device CROs. They come into effect on October 1, 2024.

China Reference Listed Drugs (RLD) application requirements for Chemical Generic Drugs was issued by the CDE in 2022.

China motor vehicles CCC Certification and Implementation Requirements (CCAP-C11-01:2020) have been revised and published by CCAP on April 30, 2024.

China Compulsory Certification rules for Wire, Cable and other products have been revised and were published by CNCA on April 15, 2024.

China Contract Drug Manufacturing Provisions were issued back in October 2023 to strengthen the supervision and management of the entrusted production of drugs.

Formula food for special medical purposes (FSMP) clinical trial standards in China were recently updated by the SAMR on May 11, 2024.

China Cosmetic Adverse Event Reporting is crucial to maintaining compliance post-notification or post-registration of your cosmetics.

To improve the review process, a 60-day response period allows applicants to address any deficiencies identified by the Hong Kong Drug Office