Pharma & Biotech

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.

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.

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.

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.

The China CDE has released new guidelines on biosimilars, Mediterranean anemia gene therapies, and patient-reported outcomes in rheumatolo...

...risks associated with segmented production and provide technical requirements for products such as Antibody-Drug Conjugates (ADCs).|...risks associated with segmented production and provide technical requirements for products such as Antibody-Drug Conjugates (ADCs).

China rare disease drugs clinical pharmacology research technical guidelines have been drafted for comments by the CDE on October 12, 2024.