Pharma & Biotech

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.

CDE’s 2024 Annual Report reviews 4,900 clinical trials in China. Contact Cisema for drug registration timelines and regulatory compliance.

Join Cisema and HKSTP for a webinar on Hong Kong’s regulatory pathways and GBA market access for life and health tech ventures.

China introduces a dual drug catalog system in 2025, creating new access routes for innovative drugs through commercial insurance.

China’s NMPA revises 2025 regulations for narcotic and psychotropic drug research. Overseas manufacturers must meet strict compliance.

Meta Description Learn how the NIFDC 2025 drug registration testing revision impacts timelines, sample rules, and pre-testing in China’s pharmaceutical market.