Early access to medicines, adaptive licensing and a new 'breakthrough' designation - UK expert group wish list
This article was originally published in SRA
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 possible1,2. It also urges the European Medicines Agency to make progress on its delayed adaptive licensing project, and calls for a designation similar to the breakthrough therapy status that was recently introduced in the US.