You Say Goodbye, I Say Hello – MHRA Moves In, EMA Moves Out
The UK Medicines and Healthcare products Regulatory Agency is relocating to the very area in east London the European Medicines Agency is being forced to abandon.
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EU Postpones Decision On EMA’s New Home To November
The decision on where the European Medicines Agency should be located after the UK leaves the EU has been postponed to November. The European Council has published details of the bidding process countries must follow if they want to host the EMA.
Danon Disease Gene Therapy & TGCT Treatment Win EMA PRIME Designations
Promising early clinical trial results from Rocket and Abbisko respectively helped the companies secure their places on the European Medicines Agency’s priority medicines scheme, which aims to help speed up the development and regulatory review of treatments for unmet medical needs.
Companies Weigh In On How To Tackle EU Regulatory & Reimbursement Barriers To Digital Therapeutics
When it comes to digital therapeutics in Europe, EFPIA says there is a lack of harmonization in the regulatory requirements, and only Belgium and Germany offer value assessment, reimbursement and funding pathways, with more intermittent offerings in countries like France and UK.