Pharma & Biotech

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.

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.

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.

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

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.

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

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.