Pharma & Biotech

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.

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NMPA draft guidance on cell therapy change control, impacting international CGT market access in China.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

China enforces traceability code scanning for medical insurance from July 2025. Overseas drug makers must align systems to maintain market access.

China issues further proposals to improve review speed, submission standards, and ethics oversight for innovative drug clinical trials.

The CDE released a draft on ATMPs to refine the regulatory process. Review the guidelines and contact Cisema for assistance.

CDE issues PACMP guidance to streamline post-approval pharmaceutical changes in China. Public comments due by July 8, 2025.