OBJECTIVES: Regulatory science (RS) grounds its value on enhancing regulatory capacity through developing and adopting scientific disciplines applicable to the evaluation of health-related products. While drug regulatory authorities (DRAs) are increasingly engaged with RS, their approaches have not been systemically examined. This research aimed to analyze the experiences of RS development based on a cross-country comparison guided by the logic modeling.

METHODS: DRAs in China (National Medical Products Administration, NMPA), the United States (Food and Drug Administration, FDA), the European Union (European Medicines Agency, EMA) and Japan (Pharmaceuticals and Medical Devices Agency, PMDA) were the study targets as they had officially launched RA initiatives. Documentary analysis of government documents and scoping literature review were conducted for data collection.

RESULTS: Despite a lack of universal definition across the DRAs, the visions for RS were set as the development of new tools, standards and guidelines for more thorough and timely assessment of risks and benefits of the regulated products throughout the product life-cycle. The priority areas set by the DRAs could be a mix of technology-based (e.g. Toxicology, FDA), process-based (partnership with healthcare systems, EMA or high quality review/consultation services, PMDA) or product-based (drug-device combination products, NMPA) goals. Collective actions were commonly taken to advance RS. Internally, resources were allocated for staff scientific training, information technology and laboratory infrastructure. Various collaborations were encouraged through public-private partnerships, direct funding mechanisms and innovation network. Among themselves, DRAs fostered collaboration in decision-making process, developed horizon scanning system, and communicated regularly through consortium. The output measured included scientific publications, conferences, funded projects, training programs, evaluation methods and regulatory guidelines. Outcomes demonstrated included enhanced staff capacity, increased regulatory efficiency and transparency, and improved cross-boundary communication.

CONCLUSIONS: Continuous support and regular review of RS development are important for DRAs to meet the scientific challenges in regulation more effectively.