How Do Drug Regulatory Bodies Deal With Potential Innovative Therapies?

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ID: 90897
2020
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Abstract
Given the extensive development of new molecules over the last 10 years, regulatory authorities (RAs) have been intensively working on evaluating how to identify and manage "innovative" drugs. The purpose of this article is to analyze whether RAs have procedures capable of ensuring access to innovative drug therapies and to understand what criteria RAs around the world (Europe, USA, Canada, Australia, and Japan) use to identify innovative drugs, comparing the different strategies and tools used to prioritize the assessment of the most promising drugs. All the RAs under review consistently use two elements to speed up drug access: (1) the handling (shortening) of approval times and the (2) management of the (limited) evidence available. No international RA utilizes any state-of-the-art method to evaluate the innovativeness of medicinal products. Harmonizing a definition and the criteria used to define pharmaceutical innovation would allow faster access to patients.
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tutone2020howtherapeutic Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors Tutone, Michaela;Villa, Federico;Addis, Antonio;Trotta, Francesco;Tafuri, Giovanni;
Journal therapeutic innovation & regulatory science
Year 2020
DOI
10.1007/s43441-019-00045-x
URL
Keywords
fda tga ema hc drug innovation regulatory approval

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