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Pharmaceutical regulation in the single European market
1ESRC Centre for the Study of Globalisation and Regionalisation, University of Warwick.
Medicine and Law
|January 29, 1999
Abstract:
This paper assesses the impact of new EU-wide drug authorisation procedures. The paper examines various attempts to introduce harmonised market authorisation routes for pharmaceuticals including the establishment of the multi-state, concentration, decentralised and centralised procedures. The paper considers the current role of the European Medicines Evaluation Agency and the likelihood that its powers will be increased in the future. Finally, the paper assesses whether EU regulation has created beneficial market conditions for pharmaceutical companies operating in the single European market.