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EU National Agencies Prepare For ‘Rebalancing’ Of Network Post Brexit

Executive Summary

The UK has formally notified the EU of its plans to leave the trading bloc and formal Brexit talks will begin soon. In the meantime, pharmaceutical regulators in the remaining 27 EU member states are having to plan for a future without the UK regulatory agency, the MHRA. In the UK, “Day 1” of Brexit is focusing minds.

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Despite Brexit, UK Regulator Remains Pharma Favorite – For Now

The European medicines regulatory network is planning for a worst-case scenario and is advising drug companies to do the same to ensure there are no last-minute disruptions when the UK leaves the EU at the end of March 2019. It appears this advice has yet to have an effect on the industry’s preference for the UK to lead the evaluation of human medicines under the decentralized procedure. The Pink Sheet‘s Vibha Sharma spoke to two senior national regulators to find out how the network is coping with the situation.

Brexit: Scenario Planning Well Under Way At EMA

The EMA has outlined some of the planning that has been going on in preparation for its relocation from the UK to another EU member state as a result of Brexit, including ongoing relations with the UK regulator, the MHRA.

Politics Could Get In Way Of Quick Decision On New EMA Home

An early decision on the new home for the European Medicines Agency would help to minimize the level of disruption that will be involved in moving the agency from London to somewhere else in Europe when the UK leaves the EU. The EMA and the European Parliament have both called for quick resolution on this, but what you want is not always what you get.

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