News

New customs measures taking effect in December 2026 will reshape how cosmetics are inspected, cleared, labeled, and electronically verified in China.

7 product categories will be subject to revised energy efficiency labeling requirements under a phased rollout beginning in June 2026.

The updated GN-00 guidance reduces classification uncertainty and creates clearer MDACS pathways for injectable dermal fillers in Hong Kong.

Malaysia’s MDA has issued major updates affecting medical device classification, special access exemptions, and management of obsolete and discontinued devices under the Medical Device Act 2012

New measures define vigilance management, inspections, PSURs, trend reporting, and reporting requirements in 17 pilot regions

China’s NMPA released a AI roadmap for smarter supervision across drugs, medical devices, and cosmetics regulation, covering AI-supported review, inspections, traceability, risk monitoring, and digital governance through 2035.

TFDA adopted ICH E9(R1) guidance on estimands, intercurrent events, missing data, and sensitivity analysis for drug clinical trial management.

China’s NIFDC releases 6 new technical guidelines for high-risk cosmetics, impacting hair dye, perming, and sunscreen product compliance.

Hong Kong introduces Primary Evaluation Phase 1 for NDAs, requiring pathway selection across 3 routes and reshaping drug registration strategy.

Hong Kong classifies classifcation of injectable products, impacting medical aesthetics and borderline products.

The reforms introduce new drug pricing rules, clarified conditional approval procedures, and tiered care measures.

TFDA eliminates legacy cosmetics review fees, reducing compliance costs for foreign companies.

CMDE maps 275 guideline updates, tightening requirements and giving manufacturers early visibility for planning and compliance.

CNCA issued 11 trial CCC certification implementation rules for fuses, electric tools, welding machines, automotive components, and safety glass.

China’s MIIT and nine ministries introduce a new AI ethics review and services framework establishing tiered oversight, compliance obligations, and governance pathways for AI activities in China.

China issues new guidelines on medical device adverse event risk evaluation and periodic report review, tightening post-market surveillance requirements

China’s CMDE releases a new IVUS registration review guideline, defining technical, clinical, and testing requirements for NMPA medical device registration

Malaysia’s MDA publishes the 7th edition of guidance on medical device labelling, with new e-labelling, e-IFU, and accessibility requirements

Vietnam’s Drug Administration (DAV) is stepping up cosmetic product recalls as post-market surveillance tightens.

BPOM confirms pharmaceutical authorization, GMP oversight, and regulatory authority remain unchanged under the Indonesia–US trade agreement.