Pharma & Biotech

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.

On March 10, 2025, the NMPA implemented new guidelines for chemical drug registration in China. Learn about stricter electronic submissions, compliance requirements, and their impact on international pharmaceutical companies.

Document No. 53, outlining comprehensive reforms aimed at strengthening the regulation of pharmaceuticals and medical devices. These reforms..

The NMPA issued a draft policy aimed at simplifying the registration and approval process for traditional oral Chinese patent medicines...|The NMPA issued a draft policy aimed at simplifying the registration and approval process for traditional oral Chinese patent medicines...