Pharma & Biotech

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...

The NHSA has released the 2024 National Medical Insurance Drug List (NEDL) and launched updates regarding this year’s drug price....

The Center for Drug Evaluation (CDE) issued Traditional Chinese Medicine clinical development guidelines on November 19, 2024....

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

The CDE has released three key guidelines, between September and November 2024, aimed at providing technical direction…|The CDE has released three key guidelines, between September and November 2024, aimed at providing technical direction…