IMR Press / FBE / Volume 5 / Issue 2 / DOI: 10.2741/E627

Frontiers in Bioscience-Elite (FBE) is published by IMR Press from Volume 13 Issue 2 (2021). Previous articles were published by another publisher on a subscription basis, and they are hosted by IMR Press on imrpress.com as a courtesy and upon agreement with Frontiers in Bioscience.

Open Access Review

Regulatory affairs issues and legal ontologies in drug development

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1 Computer Science Faculty, University of A Coruna, Campus de Elvina s/n, 15071 A Coruna, Spain
2 Romanian Academy, C. I. Parhon, National Institute of Endocrinology, 011863 Bucharest, Romania
3 Grunenthal Pharma GmbH, Zieglerstrasse 6, 52078 Aachen, Germany

*Author to whom correspondence should be addressed.

Academic Editor: Aliuska Duardo-Sanchez

Front. Biosci. (Elite Ed) 2013, 5(2), 446–460; https://doi.org/10.2741/E627
Published: 1 January 2013
(This article belongs to the Special Issue Legal issues for chem-bioinformatics models)
Abstract

It usually can take more than ten years from the time a new drug is discovered, until can be launched on the market. Regulatory requirements are part of the process of drug discovery and drug development. It acts at every developmental stage. Regulatory affairs works to establish an effective and uniform balance between voluntary and regulatory compliance and agency responsiveness to consumer needs. It evaluates and coordinates all proposed legal actions to ascertain compliance with regulatory policy. The ontology presented for regulatory affairs and drug research and development gives us the possibility to correlate information from different levels and to discover new relationships between the legal aspects. In addition, the transparency of the information is affected by the inability of existing integration strategies to organize and apply the available knowledge to the range of real scientific and business issue in critical safety and regulatory applications. Therefore, the semantic technologies based on ontologies make the knowledge reusable by several applications across business, from discovery to corporate affairs.

Keywords
Regulatory affairs
Drug development
Ontology
Legal aspects
Review
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