Pharma & Biotech

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China's CDE releases draft guidance on selecting subjects for bioequivalence and pharmacokinetic studies of antitumor and biosimilar drugs.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

China’s 2024 Annual Report on Drug Adverse Reactions reveals a rise in serious cases, including those involving imported drugs.

China's Category C drug list, launching in September 2025, offers a new commercial insurance-based payment path for innovative drugs.

The Center for Drug Evaluation (CDE) in China accepted over 19,500 drug registration applications in 2024. Learn how evolving regulatory trends impact pharmaceutical market access for international companies.

Learn about the new standards of the Chinese Pharmacopoeia 2025 Edition, implemented Oct 1, 2025, as well as relevant compliance strategies.