Regulatory News from Across Asia-Pacific

China's bisacodyl food regulation 2025 under Notice No 12 bans its use in food International manufacturers must act to ensure compliance.

China’s new food additive plan tightens rules on import, production, and sales, with major compliance impacts for global manufacturers.

China revises toy and smoke detector standards GB 19865-2024 and GB 4715-2024. Key changes affect CCC certification and compliance timelines.

NMPA issues Medical Device Clinical Evaluation Exemption 2025 impacting international medical device registration strategies

CMDE issues rules for faster medical device reviews, supporting innovation and speeding up market access in China.

NMPA Q&A clarifies medical device site inspection compliance, guiding overseas manufacturers on release, quality, and system standards.

Taiwan spray cosmetics labeling requirements have been newly clarified with the release of a safety guideline on June 23, 2025, by the TFDA.

Malaysia and China launch a regulatory reliance pilot to streamline IVD medical device registration and accelerate cross-border market access.

Learn how China's GB 7718-2025 food labeling standard and new digital label rules affect imported foods before the March 2027 compliance deadline.

China issues further proposals to improve review speed, submission standards, and ethics oversight for innovative drug clinical trials.

The CDE released a draft on ATMPs to refine the regulatory process. Review the guidelines and contact Cisema for assistance.

CDE issues PACMP guidance to streamline post-approval pharmaceutical changes in China. Public comments due by July 8, 2025.

CDE issues geriatric drug development guidelines. Public comments due June 18, 2025. Key impact for international pharma companies.

China's CDE releases draft guidance on selecting subjects for bioequivalence and pharmacokinetic studies of antitumor and biosimilar drugs.

China releases draft guideline on risk management plans for innovative drugs, aligning with global standards. Review impact and prepare compliance steps.

New NMPA methods, including hard particle testing in toothpaste, will be added to China’s cosmetic safety standards effective March 2026.

China’s 2025 IVD clinical trial exemption catalogue expands to 445 products, affecting clinical evidence requirements and IVD registration in China.

China’s 2025 enforcement cases spotlight compliance risks in medical device online sales and what global sellers must do to stay aligned.

New CDE policies reshape pediatric drug trials in China, focusing on safety and innovation for international pharma compliance.

Learn about CMDE’s new guidelines on titanium implant device registration in China and how they impact international manufacturers.