Innovation in Regulatory Science: Evolution of a New Scientific Discipline

Abstract

Regulatory science is increasingly recognized as an evolving science serving regulatory and other policy decisions. This article reviews the evolution of regulatory science and how various authors and organizations have defined it. The article identifies various tools, including Metrics for Evaluation of Regulatory Science information, peer review, risk assessment, scientific assessment, and economics. Subsequently, the article describes three phases of regulatory science consisting of the initial phase when decisions were made using inadequate scientific information, the exploratory phase when various tools were developed, and the standard operating phase when tools are used to reevaluate decisions made during the initial phase. The article concludes by indicating the need for transparency in regulatory science by identifying assumptions, judgments, and related processes during the regulatory science process.

The Japanese Postmarketing Adverse Event Relief System: A Confluence of Regulatory Science, the Legal System, and Clinical Pharmacology

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Advanced Therapy Medicinal Products' Translation in Europe: A Developers' Perspective

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Regulating Ionizing Radiation Based on Metrics for Evaluation of Regulatory Science Claims

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