Regulatory News from Across Asia-Pacific

China’s CMDE issued Notice No. 3 (2025) to fast-track innovative medical devices and raise standards for non-innovative products.

Learn how China’s medical device master file system supports confidential documentation, protects IP, and streamlines regulatory reviews for international manufacturers.

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.

Key outcomes from China’s 2025 Two Sessions highlight regulatory updates, innovation policies, and new market opportunities for international medical device manufacturers.

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

The NMPA has released the 2025 National Medical Device Sampling Inspection Plan. Learn about new inspection processes, reinspection rights, and compliance strategies for entering the Chinese market.

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.

The NMPA's updated Guidelines for On-site Inspection of Medical Device Distribution took effect on July 1, 2024, replacing the 2015 version. Learn how these changes affect overseas manufacturers entering the Chinese market.

Effective March 19, 2025, China has implemented new classification requirements for protein-based veterinary medicines. Learn how this impacts international manufacturers and what steps to take for compliance.

China’s SAMR mandates CCC certification for electric vehicle power supply equipment starting March 2025. Learn about key regulations, timelines, and how international manufacturers can comply.

The NMPA's 2024 report introduces over 2,000 medical device standards, impacting registration and compliance for international manufacturers in China.

From July 1, 2025, international cosmetic manufacturers must comply with five new testing methods in China under updated NMPA regulations.

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.

Stay ahead of China’s 2025 automotive certification updates. Learn about CCC compliance, GB standards changes, and CCAP regulations affecting car parts.

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 oral healthcare market is expanding at a 12% annual rate, with dental anesthesia devices exceeding 1.8 billion yuan. Learn about clinical trends, regulatory requirements, and opportunities 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.

Starting March 1, 2025, EV power supply equipment in China must comply with the CCC certification. Businesses must meet safety standards before the August 1, 2026 deadline.

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.