Extended Impact Assessment of a Draft EC Regulation on Medicinal Products for Paediatric Use

Wija J. Oortwijn, Edwin Horlings, Silvia Anton, Mirjam van het Loo, James P. Kahan

ResearchPublished Dec 8, 2004

There is a serious lack of testing of medicinal products in the paediatric population. The European Commission has attempted to provide a structural solution by drafting a regulation. This report describes the economic, social, sustainable, and environmental impacts of the regulation. The assessment indicates that the proposed regulation will achieve its objectives, although the effects will vary.

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Oortwijn, Wija J., Edwin Horlings, Silvia Anton, Mirjam van het Loo, and James P. Kahan, Extended Impact Assessment of a Draft EC Regulation on Medicinal Products for Paediatric Use. Santa Monica, CA: RAND Corporation, 2004. https://www.rand.org/pubs/monographs/MG308.html.
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