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A farewell to NEES

This article was originally published in SRA

Executive Summary

“Where there is discord, let me bring harmony.” On the face of it, this would appear to be an adaptation of the prayer of St Francis of Assisi or, to the British public of 1979, an extract from the post-election speech of former Prime Minister Margaret Thatcher. Personally, I prefer to view it as a mantra for the EU, a phrase that emboldens the vision of the single market and affects most areas of policy-making and regulation. In this sense, it also applies to electronic submissions for drug marketing authorisations and accompanying applications. But harmonisation is at present a distant dream in this area, with two main submission standards clouding the picture.

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