The Emergence of Regulatory Science in Pharmaceutical Medicine
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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.
KeywordsRegulatory Science Pharmaceutical Medicine H1N1 Vaccine Regulatory Principle Regulatory Affair
Neither Dr Callréus nor Dr Schneider has any relevant conflicts of interest. No sources of funding were used to prepare this article. The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties.
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