Pharma & Biotech

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

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

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

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

China’s CDE released guidelines on clinical trials of locally applied, locally acting products to improve drug development and evaluation

The China GMP for Pharmaceutical Packaging guides pharmaceutical marketing license holders in reviewing packaging material suppliers.

NMPA solicits comments on the revised draft of China's medical device classification for sodium hyaluronate products until June 16, 2022.