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Gatekeepers and Enablers: How Drug Regulators Respond to a Challenging and Changing Environment by Moving Toward a Proactive Attitude
Author(s) -
Ehmann F,
Papaluca Amati M,
Salmonson T,
Posch M,
Vamvakas S,
Hemmings R,
Eichler H G,
Schneider C K
Publication year - 2013
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2013.14
Subject(s) - clinical pharmacology , regulatory science , drug development , business , engineering ethics , public relations , knowledge management , pharmacology , process management , drug , political science , medicine , engineering , computer science , pathology
This article analyzes the role of regulatory authorities in facilitating innovation in the pharmaceutical sector. We describe how regulators are expanding their role to be not only gatekeepers but also enablers of development. They have already responded to the challenging and changing environment by moving toward a proactive attitude beyond evaluation of products, thereby more actively contributing to their development. Regulators have to continuously evolve their knowledge and standards alongside evolution in science. Creation of supportive regulatory frameworks and multistakeholder interaction will help address unmet regulatory needs. Clinical Pharmacology & Therapeutics (2013); 93 5, 425–432. doi: 10.1038/clpt.2013.14