Globally harmonized specifications: Implementing a patient-centric, enhanced control strategy - a meeting report

On June 23-25, 2025, the International Alliance for Biological Standardization (IABS) hosted the fourth Global Harmonization of Specifications Workshop in Tokyo, Japan, in collaboration with the National Institute of Health Sciences. This first Asian edition convened regulators, industry experts, and stakeholders to advance patient-centric, science- and risk-based approaches for setting specifications in biologics, including vaccines, biotherapeutics, and cell and gene therapies (CGT). The workshop featured a keynote on retinal cell therapy strategies, updates on International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use Q6 (R1) revisions, case studies demonstrating enhanced versus traditional specification setting, and discussions on pharmacopoeia harmonization and lifecycle management. Breakout sessions highlighted modality-specific challenges: CGT emphasized patient variability and flexible lot release; vaccines focused on potency and legacy assay transitions; biotherapeutics highlighted challenges with the unnecessary specification of non-critical quality attributes. Key themes included distinguishing specifications from process monitoring, leveraging prior knowledge and statistical modeling for clinically relevant ranges, and fostering global reliance to achieve "one product-one specification." Participants called for case studies, regulatory education, and collaborative platforms to overcome regional divergences, ensuring innovation, supply stability, and patient access worldwide.