Gatekeepers and enablers: how drug regulators respond to a challenging and changing environment by moving toward a proactive attitude

Clin Pharmacol Ther. 2013 May;93(5):425-32. doi: 10.1038/clpt.2013.14. Epub 2013 Jan 24.

Abstract

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.

MeSH terms

  • Drug Approval
  • Drug Design*
  • Drug Industry / legislation & jurisprudence*
  • Drug Industry / organization & administration
  • Drug and Narcotic Control / legislation & jurisprudence*
  • Drug-Related Side Effects and Adverse Reactions
  • Health Services Accessibility / legislation & jurisprudence
  • Humans
  • Organizational Innovation
  • Pharmaceutical Preparations / administration & dosage
  • Pharmaceutical Preparations / supply & distribution

Substances

  • Pharmaceutical Preparations