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Master Thesis

Aspects réglementaires des médicaments orphelins destinés à la population pédiatrique : contraintes et opportunités pour l'industrie pharmaceutique

Abstract : In Europe, over 75% of the designated orphan products are potentially aimed at children. Over the past decade, two major regulations have been adopted in the field of medicinal products: regulation (EC) n°141/2000 on orphan drugs and the new paediatric regulation (EC) n° 1901/2006. This report aims at providing an overview of both of these regulations which have been established to tackle the challenges linked to drug development in these special populations. Their benefits and limits will be pointed out and a parallel with the US provisions will be drawn. In the frame of orphan drugs, major benefits have been introduced by the Paediatric Regulation (extension of market exclusivity from 10 to 12 years, creation of an European Paediatric Network). Contrary to the EU legislation, the FDA does not require paediatric studies for orphan drugs. Even if the new European Paediatric Regulation is challenging for the pharmaceutical industry, it contributes to promote clinical research in children suffering from rare diseases.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-00593263
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Submitted on : Friday, May 13, 2011 - 5:16:35 PM
Last modification on : Tuesday, May 11, 2021 - 11:36:17 AM

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  • HAL Id : dumas-00593263, version 1

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Aurélie Tireford. Aspects réglementaires des médicaments orphelins destinés à la population pédiatrique : contraintes et opportunités pour l'industrie pharmaceutique. Sciences pharmaceutiques. 2010. ⟨dumas-00593263⟩

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