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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
The UK’s post-EU standalone legislation for medical devices has continued its parliamentary journey, reaching the upper house this week. Debate on a clinical registries policy paper has begun.
Buoyed by belief in its strengths, the UK biotech sector has defied the pandemic over the last three months – but smaller firms are still strapped for cash.
A letter addressed to EU leaders has urged them to prioritize the preservation of supply chains and access to medicines for patients in both the UK and the EU as worries grow over the sluggish pace of talks on a trade deal.
Special approval procedures for new drugs and biosimilars, more use of real-world data, a streamlined drug safety monitoring system, and a ‘patient-first culture.’ The MHRA has plenty of ideas in store for its post-Brexit life as a fully independent regulator from January next year.
A month after the UK and the US began talks on a future free trade agreement, a new House of Lords committee says that an FTA involves risks as well as benefits, and has stakeholders to give their views on the likely impact of a deal in areas like drug pricing and the NHS.
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.
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