Pharma & Biotech

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.

Get a summary of three new CDE draft regulatory guidelines that cover mRNA vaccine research, DSUR reporting, and CAR-T product instructions.

CDE releases draft guideline introducing flexible regulatory pathways for rare disease drugs to reduce costs and accelerate time-to-market.

China’s CDE issues draft guidelines on pharmaceutical packaging, impacting GMP compliance and product registration.

China’s new CDE guidelines on Model-Informed Drug Development and rare disease pharmacology: key impacts on regulatory strategy and access.