---
title: "Regulatory science"
chunk: 2/2
source: "https://en.wikipedia.org/wiki/Regulatory_science"
category: "reference"
tags: "science, encyclopedia"
date_saved: "2026-05-05T03:55:38.508835+00:00"
instance: "kb-cron"
---

=== Regulatory pharmaceutical medicine ===
Consistent with its mission, the Food and Drug Administration (FDA) suggests, “Regulatory science is the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.”
Based on several decades of experience regulatory science is logically defined as a distinct scientific discipline constituting the scientific foundation of regulatory, legislative, and judicial decisions. Much like many scientific disciplines that have evolved within the last several decades, regulatory science is both interdisciplinary and multidisciplinary and relies upon a large number of basic and applied scientific disciplines.
Regulatory science is an emerging area of interest within pharmaceutical medicine as the shaping and implementation of legislation and guidelines. One definition of “regulatory science” is the science of developing new tools, standards and approaches to evaluate the efficacy, safety, quality and performance of medical products in order to assess benefit-risk and facilitate a sound and transparent regulatory decision-making. It has been recognized as having a significant impact on the industry’s ability to bring new medicines and medical devices to patients in need. Regulatory science challenges current concepts of benefit/risk assessment, submission and approval strategies, patient’s involvement and ethical aspects. It creates the platform for launching new ideas – not only by the pharmaceutical industry and regulatory authorities, but also by, for example, academia, who wants to contribute to better use of their research activities within medical aspects. Regulatory science  has the potential as an enabler for directing companies towards more efficient global development of medical products as well as more robust quality decision-making processes.

=== Human health ===
By far the predominant foci of regulatory science pertain to human health and well-being. This realm covers a broad range of scientific areas – including pollution and toxicology, work safety, food, drugs, and numerous others.

=== Ecology ===
Regulatory ecology covers the protection of various species, protection of wetlands, and numerous other regulated areas, including ecotoxicology.
For example, the US Clean Water Act is based upon an interest in protecting water quality for its own sake, in contrast with the Clean Air Act which is premised upon protecting air quality only for the sake of human health; however, these are ideological policy premises rather than scientific matters themselves.
The US Department of Agriculture regulates animal care, and the FDA regulates humaneness for animal studies.
The US Department of Interior, Fish and Wildlife Service (USFWS), and National Oceanographic and Atmospheric Administration, National Marine Fisheries Service, implement the development and enforcement of policies required by the Federal Endangered Species Act (FESA), Migratory Bird Treaty Act, and other biological resources laws. The FESA requires that the decisions to list a species as endangered or threatened are based on the best available scientific data. To that end, the USFWS and other government agencies fund research to determine the conservation status of proposed species. Regulatory scientists within the Services review, evaluate, and incorporate data from these studies of proposed species in their published regulations. Survey protocols for listed species are also developed from scientific studies of their target species. The purpose of the protocols is to reliably and accurately determine the residency of the target species in a given study area.

== Regulatory economics ==

There are numerous economic decisions in the regulatory process, including the economics part of cost-benefit analysis.

== Science in legislation and in courts ==
Although often less than fully recognized, the scientific foundation of legislative decisions is included in regulatory science and should be based on reliable science. Similarly, courts have recognized the need to rely upon information that meets scientific requirements.

== References ==

== Further reading ==
Honda, Hiroshi (2016). "Overview of Issues and Discussions in Regulatory Science and Engineering over the Past Four Years in Global Arena" (PDF). American Journal of Environmental Engineering and Science. 3 (1): 1–20. ISSN 2381-1153.