Pharma & Biotech

The updated technical guideline expands regulatory expectations for manufacturing, impurity control, advanced analytics, stability studies, and biosimilar comparability.

China’s NMPA and six government agencies issued new measures that strengthen compliance requirements, anti-bribery controls, and oversight of pharmaceutical promotion activities.

The new framework introduces a distinct regulatory pathway for emerging therapies, with major implications for clinical development and market strategy.

China’s SAMR has released draft advertising review measures that would increase oversight of livestreaming and digital marketing while streamlining certain compliance requirements for regulated products.

New guidance highlights the need for earlier China development planning whenrelying on global trials, foreign clinical data, or multinational development strategies

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.