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Early access, adaptive licensing & ''breakthrough'' designation – UK expert group's wish list

This article was originally published in Scrip

Executive Summary

A group of experts has called on the UK regulator, the MHRA, to sort out funding issues regarding its proposed early access to medicines scheme and to get the project up and running "as soon as possible". It also urges the European Medicines Agency to speed up its delayed adaptive licensing project, and calls for a designation similar to the "breakthrough therapy" status that was recently introduced in the US.

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