News

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.

China will enforce new safety standards for household electrical appliances starting August 1, 2026. Learn how GB/T 4706.1—2024 impacts manufacturers, importers, and compliance requirements.

Stay compliant with China’s latest regulations on pet disease antigen screening. Learn how MARA classifies veterinary diagnostic products and what it means for businesses.

China’s NMPA approved 13,133 medical device registrations in 2024, including innovative and priority-reviewed products. Learn about regulatory updates, compliance requirements, and market access opportunities for foreign manufacturers.

Learn about China's latest regulatory updates on nucleic acid testing reagents, market growth trends, and compliance requirements for manufacturers in 2025.