Pharma & Biotech

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.

China’s CDE 2025 clinical trial report covers 4,900 studies registered in 2024, highlighting key trends in drug development, therapeutic areas, and trial timelines.

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.

China GBA reimbursement frameworks have advanced to support the GBA Connect Scheme, with six cities having individually adapted policies.

NMPA draft guidance on cell therapy change control, impacting international CGT market access in China.

China Releases Revised Draft Procedures for Conditional Drug Approvals: Key Updates and Regulatory Implications