Regulatory News from Across Asia-Pacific

Chinese Pharmacopoeia 2020 edition was translated into English and officially published by the Chinese CPC on March 14, 2023.

China cosmetic e-commerce operators and the distribution of cosmetics will be subject to new rules on September 1, 2023.

China medical device industry standards March 2023 update covers 20 standards released by the NMPA for manufacturers to comply with.

Hong Kong drug and medical device registrations are increasingly in demand. ​​​​​​​Join the Cisema team for a recap of latest policy updates.

Cosmetic ingredient safety information update in China has now a longer transition period for cosmetic and raw material manufacturers

China’s IVD reagent classification catalogue has been revised and reissued for industry comment. The deadline for submission is Apr. 12, 2023

GB9706 standards for medical electrical equipment have new NMPA guidelines to help applicants determine the implementation dates

Microbial limits for non-sterile chemical drugs, API and excipients were released in a new set of guidelines by China's CDE in Feb 2023

China’s Medical Device Supplementary Notice Period reverts to 1-year period from previous 2-year temporary extension, commencing Feb 20, 2023

New registration review guidelines have been issued by China’s CMDE for dental adhesive products for dental filling and restoration, as well as restoration and bonding.

China’s Toothpaste Supervision & Administration Regulation is announced by the SAMR, and will come in effect from Dec 1, 2023, onwards

Expedited safety reporting in drug clinical trials is required for applicants to timely inform the CDE about any SUSAR events

Cisema announces Hamish King as new CEO bringing over 10 years' experience in the legal and regulatory fields.

China medical device standards management 2022 annual report was issued on February 8, 2023, to provide an overview of standards development

Medical device registrations China 2022 Annual Report shares an overview of the 11,942 medical devices successfully registered over the year

China UDI medical device third batch implementation date is June 1, 2024, as part of the continuing drive to improve supervision and...

CCC electronics self-inspection pilot work was announced on January 9, 2023, to help streamline work processes of the government and...

China motorcycle and brake hose regulatory updates have been released by the China SAC and the CQC respectively.

Medical Device Master Files in China were introduced in 2021 but the NMPA has clarified their use for the registration of medical devices

China general cosmetics filing and inspection measures are updated by the NMPA to allow for manufacturers for self-testing and inspection...