The Establishment of a Regulatory Science Center to Strengthen the Health Products Research and Development Ecosystem
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Abstract
Background: Advancements in health technology such as biopharmaceuticals, Advanced Therapy Medicinal Products (ATMPs), AI-driven medical devices, and precision medicine, pose significant challenges to current regulatory frameworks. Existing standards may no longer suffice for evaluating the quality, safety, and efficacy of such innovations. Consequently, many countries have adopted Regulatory Science to bridge the gap between health product research and development and regulatory oversight.
Objectives: To study and comparatively analyze the organizational structures, mandates, and operational mechanisms of Regulatory Science Centers from reference regulatory authorities, to synthesize and develop policy recommendations for establishing a regulatory science center tailored to the Thailand’s context, and to propose strategic recommendations and operational steps for driving the establishment of the regulatory science center.
Methods: This study employs a descriptive qualitative research design utilizing document synthesis and comparative case studies. Data were gathered from policy documents, legislation, regulatory guidelines, annual reports, and academic literature from reference regulatory authorities and analyzed using content analysis, comparative analysis, and policy synthesis. The study was conducted during January B.E.2563 – 2567.
Results: The findings indicate that leading nations have integrated regulatory science to accommodate innovative health products, focusing on the development of new assessment tools and standards, scientific advice, workforce capacity building, and public health emergency preparedness. For Thailand, Regulatory Science Center should be established with the inclusion of these functional components: 1) development of knowledge bases and evaluation tools for emerging technologies, 2) support for research design and product development to ensure regulatory compliance, 3) capacity building for personnel within the health product research and development ecosystem, and 4) real world evidence and emergency preparedness.
Conclusions: From this study, the policy recommendations for establishing a Regulatory Science Center in Thailand will strengthen the national regulatory system, reduce regulatory uncertainty, foster health product research and development, and enhance readiness for future public health challenges.
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