Center Introduction
What is Regulatory Science?
regulatory science for foods, drugs, etc.
The term ＂regulatory science for foods, drugs, etc.＂ means science related to technologies, standards, and approaches in all aspects of safety management, ranging from the evaluation in terms of safety, efficacy, quality, performance, etc. of foods, drugs, etc. to authorization, permission, and use;
(source: Act on Regulatory Science Innovation for Supporting Food and Drug Safety and Commercialization)
Regulatory Science Abroad
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Regulatory Science at the US FDA
- DefinitionScience for developing new tools, standards, and approaches to evaluate the safety, efficacy, quality, and performance of all FDA-regulated products.
- BackgroundIn 2006, a report from the Science and Technology Subcommittee of the FDA highlighted the need for regulatory science, pointing out the FDA’s incapability to conduct scientific regulation. In 2009, efforts began to establish a scientific foundation to support regulatory work and define the term “regulatory science,” and nurture regulatory science in response to rapid scientific and technological advances.
- ActivitiesIn 2010, the FDA established the Office of Regulatory Science and Innovation (ORSI) and has operated the Centers of Excellence in Regulatory Science and Innovation (CERSIs) to engage in innovative research, education, and scientific exchanges with academic institutions. Prestigious universities including the University of Maryland and Stanford University have been designated for this purpose. The FDA has identified key areas in regulatory science, including public health crisis response and the maximization of data utilization.
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Regulatory Science at the EMA in Europe
- DefinitionVarious scientific fields applied to the evaluation of the quality, safety, and efficacy of medicines, providing information for regulatory decision-making throughout the lifecycles of medicines.
- BackgroundIn 2010, the European Medicines Agency (EMA) introduced the term “regulatory science” for the first time in its Roadmap for 2015, and more recently announced the "Regulatory Science to 2025" strategy to develop regulatory science.
- ActivitiesThe UK established the Centre for Innovation in Regulatory Science (CIRS) to develop regulatory and reimbursement policies through regulatory science, and provides international forums for industry, regulators, and healthcare professionals.
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Regulatory Science at the PMDA in Japan
- Definition
- Science that provides appropriate prediction, evaluation, and judgment to integrate the results of technology in the most desirable form for people and society.
- It involves the fair and rapid prediction, evaluation, and determination of the quality, efficacy, and safety of pharmaceuticals, medical devices, and regenerative medical products based on scientific knowledge.
- BackgroundIn 2010, Japan's Council for Science and Technology Policy initiated discussions on the need for regulatory science, which led to the establishment of the Health and Medical Strategy Promotion Act in 2014 and the confirmation of the legal definition to promote the development of regulatory science
- ActivitiesThe Pharmaceuticals and Medical Devices Agency (PMDA) established the Center for Regulatory Science to ensure the fair and rapid prediction, evaluation, and determination of the quality, efficacy, and safety of pharmaceuticals, medical devices, and regenerative medical products based on scientific knowledge.
- Definition