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UK pharma groups planning M&A deals ‘must get their skates on’ and begin filing now if they want to benefit from the EU’s review process before the Brexit transition period ends on 31 December.
A free trade deal needs to be negotiated in record time and UK life sciences must face up to diverging from the EU.
Latest From Brexit
UK proposals for limited cooperation with the EU in medicines regulation, including the recognition of certificates and inspections, are one glimmer of light in an otherwise uncertain post-Brexit regulatory scenario for the UK. But time pressures and political spats over the future relationship could throw the whole enterprise into doubt.
Post-Brexit planning is now fully back on the agenda in the UK, and work to shape its post-EU medtech regulatory future is also restarting.
The UK’s ventilator and personal protective equipment shortage has been well-documented, and questions over its failure to be part of an EU procurement scheme refuse to go away.
The latest EU regulatory developments - EMA and HMA are looking to build an EU-wide real-world data platform; EU OTC firms can operate as normal in the UK until the end of the year; EMA, HMA and the EC have published key principles on how to develop and use electronic product information for medicines marketed within the EU.
The second round of the UK’s talks on exiting the EU by the end of the year have been called off over COVID-19, but whether this is a temporary derailment or a more structural issue for the UK’s planned EU separation is the question emerging.
As the UK looks to its future healthtech regulatory model after Brexit, the ABHI’s regulatory director Phil Brown suggests a system whereby the same product data can be used as the basis for entry not only to the EU, but also to global markets.
With the obvious distractions of coronavirus, the UK Medicines and Medical Devices bill has entered its second reading in parliament, accompanied by a drive for it to succeed from the government and opposition parties.
Despite the life sciences industry’s call for continued alignment of medicines regulation with the EU from next year and for some sort of co-operation with the European Medicines Agency, it seems the UK government is prepared to make only small concessions.
The UK’s decision to pull out of Europe’s Unified Patent Court system throws the future of the whole project into doubt.
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