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

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.

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.

Hong Kong’s Department of Health introduces Pre-NDA meetings to streamline new drug registrations under the “1+” mechanism.

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

China's GCP for Drugs (2025) Draft Revision proposes major updates on data governance, sponsor accountability, ethics, and technology use.

China’s CDE has launched consultations on six key updates to drug R&D communication in the 2025 draft measures.

Explore China’s latest CDE draft guidelines on oligonucleotide drugs, advanced therapies, & biologics — key insights for regulatory planning.