Pharma & Biotech

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

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...

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 clinical trials for new drug registrations were still dominated by chemical drugs for >70% in 2021 whilst biological products at >26%.

China drug registration evaluation report for 2021 released by NMPA CDE shows a record high of 47 innovative drugs passing technical review

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

China "urgently needed drugs" temporary import workflow was issued on June 29, 2022, by the NHC and NMPA, covering the requirement details.