EMA To Contact Sponsors Of Over 100 Drugs At Risk Of Shortage Post Brexit
The European Medicines Agency’s survey on industry’s preparedness for Brexit has raised serious concerns about the continued supply of 108 drugs that have manufacturing operations based solely in the UK.
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The European Medicines Agency plans to work directly with the marketing authorization holders of products that are still at risk of supply shortages to address the outstanding issues.
The BioIndustry Association is concerned about the lack of clarity on future UK-EU drug regulation after EU heads of state failed to make any tangible progress on Brexit at their much heralded end-of-June summit.
The European Medicines Agency has updated its guidance on Brexit to offer companies more advice on the regulatory changes they will need to make in areas like transfers of MAs, rapporteurships and orphan designations, multi-country packs, and Article 58 opinions.