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.
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