EU Regulators Urge Pharma To Share Their Brexit Plans
Executive Summary
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.
You may also be interested in...
EU Updates Brexit Advice On Changing UK Applicant For Ongoing Procedures
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.
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.
Brexit Won’t Alter EU Agency Heads’ Ambitious Work Plan – For Now
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.