EU Regulators Urge Pharma To Share Their Brexit Plans
Sponsors of medicines evaluated through the EU's decentralized procedure are being urged to share their plans regarding Brexit with national agencies as soon as possible to help with planning. The head of the Dutch Medicines Agency thinks that the human medicines sector can learn from the progress being made in the veterinary space on this front.
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The EU has updated its no-deal Brexit advice for drugs being evaluated through the mutual recognition and decentralized procedures. The advice explains the last-minute changes that companies can make in relation to ongoing or pending applications.
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.
Europe’s medicines agency heads say they are pressing on as planned with the priorities and activities in the joint “strategy to 2020” they have with the European Medicines Agency. But this could change and, in any case, more resources are needed and agencies need to engage more to support delivery of their plan.