Regulatory News from Across Asia-Pacific

China’s NMPA updates cosmetics testing methods, adding CBD detection and tighter impurity controls impacting global compliance.

China releases guiding principles for benefit-risk assessment using multi-regional clinical trial data to support global drug development.

China releases new subject selection guidance for anti-tumor drug bioequivalence and pharmacokinetic studies.

China’s CCC mark pilot reform requires traceability QR codes for power banks, electric bicycles, and gas appliances.

SAMR introduce stricter recall and compliance requirements for enterprises involved in cross-border e-commerce retail imported food.

China NMPA’s 2025 report highlights growth in medical device approvals, including advanced imported devices.

China’s NMPA releases 2025 annual report on medical device standardization, highlighting growth, innovation, and international alignment.

Malaysia’s NPRA introduces reliance and priority review pathways for additional indications of registered innovator drugs.

The draft 2026 catalogue defines which Class III medical devices would require clinical trial approval before trial initiation.

Malaysia’s MDA withdraws personal use medical device importation Guidance Document, directing stakeholders to updated exemption requirements.

Indonesia’s BPOM has strengthened clinical trial approval procedures and introduced detailed requirements for cosmetic clinical trials.

Malaysia’s NPRA mandates DEG and EG testing for high-risk oral liquid products, with mandatory compliance starting April 1, 2027.

Vietnam’s MoH recently published Circular drops several healthcare advertising regulations and streamlines requirements for many categories.

Malaysia’s NPRA issues Directive No. 7 of 2026 mandating the Malaysian Guideline for GCP 5th Edition for clinical trials.

Malaysia’s MDA and Thailand’s FDA launch a medical device reliance pilot to accelerate market access for Class B–D devices.

Vietnam’s draft cosmetic management decree would replace existing rules and strengthen post-market controls for cosmetic companies.

Malaysia clarifies that medical device tenders count as market placement, triggering licensing and compliance requirements.

Malaysia’s MDA will regulate aesthetic and cosmetic medical devices under the Medical Device (Designated Medical Devices) Order 2026.

NPRA Circular No. 1/2026 updates Malaysia’s cosmetic ingredient annexes to align with the ASEAN Cosmetic Directive

Circular No. 1/2026 clarifies regulatory requirements for medical device procurement tenders, such as licensing and GDPMD compliance.