Pharma & Biotech

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

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

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

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

China drug standards draft measures help ensure the safety, effectiveness and quality controllability of drugs in China

Drug recalls in China now designate market authorization holders as the key responsible entity, and have a revised regulatory framework.

Electronic submission for China drug registration applications will be available from January 1, 2023, onwards.

Changes during China drug registration shall refer to the working procedures issued by the Center for Drug Evaluation on November 11, 2022.

China drug registration electronic certificates will be issued by the NMPA from Nov. 1, 2022, onwards, for various drug-related applications

China’s vaccine regulator receiving the WHO recognition indicates that vaccines produced from the country ensures quality, safety and effe...

The medtech, cosmetics and pharmaceutical webinars will cover important China regulatory updates presented by our Cisema regulatory experts.

ICH Q13 guidelines were referred by China’s Center for Drug Evaluation to draft guidelines on continuous manufacturing for oral solid dosages