Pharma & Biotech

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.

CDE issues geriatric drug development guidelines. Public comments due June 18, 2025. Key impact for international pharma companies.

China's CDE releases draft guidance on selecting subjects for bioequivalence and pharmacokinetic studies of antitumor and biosimilar drugs.

China releases draft guideline on risk management plans for innovative drugs, aligning with global standards. Review impact and prepare compliance steps.

New CDE policies reshape pediatric drug trials in China, focusing on safety and innovation for international pharma compliance.

Hong Kong 1+ pathway allows submissions based on one CPP along with additional clinical data applicable to the Hong Kong population.

Hong Kong CMPR will be established by 2026, with a phased primary evaluation system for new drug registration implemented through 2030.

New CDE policy simplifies TCM registration from HK and Macao into mainland China under NMPA Announcement No. 7 of 2025.

Beijing and Shenzhen implement new policies to fast-track access for innovative drugs and devices in China.