Early access to medicines, adaptive licensing and a new 'breakthrough' designation - UK expert group wish list
This article was originally published in SRA
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.
You may also be interested in...
As the final scheduled round of post-Brexit trade talks begins amid growing concern over the prospect of a deal and the pervasive threat of COVID-19, the pharmaceutical industry in the UK and the EU have issued an urgent call for an MRA on medicines GMP. They also want to see a one-year phase-in of medicines-related aspects of the Northern Ireland Protocol.
With coronavirus cases again on the rise in many European countries, members of two EU parliamentary committees asked industry representatives to explain why details of COVID-19 vaccine supply agreements are being kept under wraps.
The UK regulator wants to be a “catalyst for change” in reducing regulatory burdens, saying that better regulation based on science is in everyone’s interest.