Pharma & Biotech

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.

The NMPA’s 2024 national drug sampling covered 136 varieties and 20,604 batches, achieving a 99.4% compliance rate.

On March 17, 2025, the NMPA published a draft revision of the GMP Annex for Sterile Pharmaceuticals. Overseas manufacturers must align with the new requirements to ensure compliance and continued market access in China.

Effective July 1, 2025, China’s NMPA will implement new GMP annexes for pharmaceutical excipients and packaging materials. Learn about compliance requirements and key timelines for international manufacturers.

The NMPA's new biological product registration guidelines take effect on March 10, 2025. Learn about updated submission requirements, compliance rules, and approval pathways for international manufacturers.

China's NMPA introduced new statistical guidelines for vaccine clinical trials in December 2024. Learn how these changes impact trial design, data analysis, and regulatory compliance.