News

From Sept 2025, Malaysia and Singapore launch a 6-month pilot to fast track medical device registration across ASEAN. Contact Cisema today.

Meta Description Learn how the NIFDC 2025 drug registration testing revision impacts timelines, sample rules, and pre-testing in China’s pharmaceutical market.

China GBA reimbursement frameworks have advanced to support the GBA Connect Scheme, with six cities having individually adapted policies.

NMPA draft guidance on cell therapy change control, impacting international CGT market access in China.

China Releases Revised Draft Procedures for Conditional Drug Approvals: Key Updates and Regulatory Implications

China enforces traceability code scanning for medical insurance from July 2025. Overseas drug makers must align systems to maintain market access.

NMPA’s draft guide defines medical device registration self-testing and self-checking for Class II and III devices under China’s QMS rules.

China's 2024 national cosmetics inspection annual report highlights key compliance issues. International manufacturers should review regulatory risks and adapt accordingly.

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.