Pharma & Biotech

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

The Real-World Evidence draft guideline aims to improve the communication between applicants and the reviewer for drug registrations in China.

ICH E8 (R1) General Considerations for Clinical Studies will be applied in China in July 2023 together with E14 Clinical Evaluation of QT/Q...

China cross border data transfer security assessments new measures have been issued by the Cyberspace Administration of China (CAC)

China Vaccine Production and Distribution Rules were released by the NMPA on July 8, 2022 and came into effect immediately.

China drug real-world study design and protocol framework guidelines (draft) for comments will be open until September 7, 2022.

Contract manufacturing of Hong Kong medical device and drug in GBA is supported by China NMPA's implementation plan announced in June 2022