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With the UK no nearer to deciding how hard or soft its exit from the EU will be on March 29, AstraZeneca and Ipsen have given updates on their efforts to cope with the chaos that could ensue on the medicines supply front.
A worst-case Brexit scenario – a disorderly one – has become more likely, making an already white-knuckled life sciences industry step up its preparations.
Latest From Brexit
Most low-risk medical devices and IVDs do not need notified body involvement in the EU. This means that, in the event of a no-deal Brexit, they are not impacted by UK government rules that focus on notified bodies. But what will change for low-risk devices and IVDs in the UK post-March 29, the UK's scheduled EU exit day?
The BioIndustry Association’s latest Brexit webinar looked at issues such as companies’ drug filing strategies in a no-deal scenario as well as the costs that industry is likely to incur as a result of changes to regulatory processes.
The government has said it is prepared to discuss the terms of supplementary protection certificates under a UK-only regime if there is a no-deal Brexit, but concerns also linger over the start dates for regulatory data protection.
The National Institute for Health and Care Excellence does not agree with assertions by the US pharmaceutical industry that its HTA process are “rigid” and “fail to recognize the full value of innovative medicines.”
There is now even more urgency for medtech companies, including small firms, to employ the services of EU27 notified bodies – with UK notified bodies set to have their conformity assessment roles temporarily withdrawn if the UK leaves on March 29 without a deal.
It is not only the UK trading relationship with the EU that could be interrupted after post-Brexit; relationships with countries with whom it enjoys mutual recognition agreements currently via the EU are also in jeopardy. How much progress has been made? And what happens next?
Europe’s ambitious new system for verifying the authenticity of prescription medicines circulating on the market is about to come into operation.
PhRMA says a UK-US post-Brexit trade agreement should cover good practices in the areas of manufacturing and clinical trials, and wants aligned regulatory approaches to drug development.
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