The emergence of regulatory science in pharmaceutical medicine

被引：1

作者：

Callréus T. ^{[1
]}

Schneider C.K. ^{[1
,2
,3
]}

机构：

[1] Danish Health and Medicines Authority, 2300 Copenhagen

[2] Twincore Centre for Experimental, Clinical Infection Research, Hannover

[3] Committee for Advanced Therapy Medicinal Products (CAT), European Medicines Agency (EMA), London

来源：

Pharmaceutical Medicine | 2013年 / 27卷 / 6期

关键词：

Regulatory Science; Pharmaceutical Medicine; H1N1 Vaccine; Regulatory Principle; Regulatory Affair;

D O I：

10.1007/s40290-013-0039-x

中图分类号：

学科分类号：

摘要：

Against a backdrop of increasing costs and poor productivity, the concept of 'regulatory science' has sometimes been invoked in recent years in discussions regarding regulation of pharmaceuticals. There is not one generally accepted definition of regulatory science; however, there are several proposed definitions centered on a common theme: the 'brand of science' (knowledge, tools, concepts, etc.) that underpins and evolves regulatory decision making. This article provides a short review of the origins and features of regulatory science in addition to an exploration of its current and potential future role in pharmaceutical medicine. Moreover, the article discusses how regulatory science differs from traditional academic science and how it is related to the concept of regulatory affairs. It is concluded that the emerging field of regulatory science is likely to influence the future shaping and implementation of laws and regulations. © 2013 Springer International Publishing Switzerland.

引用

页码：345 / 351

页数：6

共 46 条

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