Pharma & Biotech

NMPA CDE clarifies CMC expectations for preventive mRNA vaccines, focusing on LNP control, impurity management, and lifecycle comparability.

China’s CDE issued trial guidance on CMC lifecycle changes for cell therapies, emphasizing comparability and risk-based quality assessment.

China’s State Council has revised the Drug Administration Law implementation regulations under Decree No.828, introducing innovation incentives, expanded data protection, and stricter MAH obligations effective May 15, 2026.

Guangdong’s MPA and Health Commission issued the 2025 GBA Connect “urgently needed” catalogue covering 115 Hong Kong–Macao drugs and devices.

China’s NMPA will apply ICH M14 to non-interventional real-world evidence safety studies initiated on or after its January 2026 announcement.

The NMPA has introduced faster review decisions, coordinated inspections, and improved temporary import pathways for urgently needed overseas-marketed drugs.

China has issued the Fourth Batch of its Encouraged Generic Drugs Catalogue, opening new market opportunities for pharmaceutical companies.

Guangdong MPA expands GBA Connect Scheme to 71 hospitals, speeding urgent clinical access for Hong Kong and Macau-approved medical products.

Cisema has the capability to help you comply with Hong Kong MDACS requirements and expand your businesses in the Greater Bay Area

The State Administration for Market Regulation addressed the innovative development plan actions for drugs and medical devices in the Greater Bay Area.

Importing drugs and medical devices from Hong Kong have been approved and amounted up to 15 products into the GBA as of March 2022.

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