Pharma & Biotech

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.

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

Learn the registration requirements, scope, and compliance steps as Hong Kong regulates medical gases as pharmaceutical products.

China’s CDE released three 2026 trial guidelines on Phase III design for chronic insomnia, neuropathic pain, and depressive disorders.

NMPA CDE clarifies CMC expectations for preventive mRNA vaccines, focusing on LNP control, impurity management, and lifecycle comparability.

China’s CDE issued trial guidance on CMC lifecycle changes for cell therapies, emphasizing comparability and risk-based quality assessment.

China’s NMPA will apply ICH M14 to non-interventional real-world evidence safety studies initiated on or after its January 2026 announcement.

China’s State Council has revised the Drug Administration Law implementation regulations under Decree No.828, introducing innovation incentives, expanded data protection, and stricter MAH obligations effective May 15, 2026.