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Drug approval in Europe

Abstract

The EMEA gets good grades, but has room for improvement.

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Figure 1: The EMEA's centralized procedure for approval of medicinal products within the EU.

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  1. Office for Official Publications of the European Communities, 2 Rue de Mercier, L-2985, Luxembourg.

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Acknowledgements

The author wishes to acknowledge the EMEA home page and annual reports as the source of much of the data provided. The assistance of various EMEA staff is also acknowledged, as is that of the regulatory affairs personnel of various companies who responded to an informal survey carried out in preparation for this article.

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Walsh, G. Drug approval in Europe. Nat Biotechnol 17, 237–240 (1999). https://doi.org/10.1038/6977

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