National Center for Toxicological Research, US Food and Drug Administration, Jefferson, Arkansas 72079, USA.
Toxicol Sci. 2013 Jan;131(1):9-12. doi: 10.1093/toxsci/kfs254. Epub 2012 Aug 24.
Regulatory science encompasses the tools, models, techniques, and studies needed to assess and evaluate product safety, efficacy, quality, and performance. Several recent publications have emphasized the role of regulatory science in improving global health, supporting economic development and fostering innovation. As for other scientific disciplines, research in regulatory science is the critical element underpinning the development and advancement of regulatory science as a modern scientific discipline. As a regulatory agency in the 21st century, the Food and Drug Administration (FDA) has an international component that underpins its domestic mission; foods, drugs, and devices are developed and imported to the United States from across the world. The Global Summit on Regulatory Science, an international conference for discussing innovative technologies, approaches, and partnerships that enhance the translation of basic science into regulatory applications, is providing leadership for the advancement of regulatory sciences within the global context. Held annually, this international conference provides a platform where regulators, policy makers, and bench scientists from various countries can exchange views on how to develop, apply, and implement innovative methodologies into regulatory assessments in their respective countries, as well as developing a harmonized strategy to improve global public health through global collaboration.
监管科学涵盖了评估和评估产品安全性、有效性、质量和性能所需的工具、模型、技术和研究。最近的一些出版物强调了监管科学在改善全球健康、支持经济发展和促进创新方面的作用。与其他科学学科一样，监管科学研究是支撑监管科学作为现代科学学科发展和进步的关键要素。作为 21 世纪的监管机构，美国食品和药物管理局 (FDA) 拥有一个支撑其国内使命的国际组成部分；食品、药品和医疗器械都是从世界各地开发和进口到美国的。全球监管科学峰会是一个讨论创新技术、方法和伙伴关系的国际会议，这些技术、方法和伙伴关系可以促进将基础科学转化为监管应用，为在全球范围内推进监管科学提供了领导。该国际会议每年举办一次，为来自不同国家的监管机构、政策制定者和基础科学家提供了一个交流平台，讨论如何在各自国家的监管评估中开发、应用和实施创新方法，以及制定一项通过全球合作改善全球公共卫生的协调战略。
