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Set Alert for Brexit

AZ And Ipsen Outline Brexit Contingency Plans

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.

United Kingdom Brexit Distribution

Pharma Industry Holds Tight As Disorderly Brexit Approaches

A worst-case Brexit scenario – a disorderly one – has become more likely, making an already white-knuckled life sciences industry step up its preparations.

Brexit Trade Business Strategies

Latest From Brexit

How Are Low-Risk Devices And IVDs Impacted By A No-Deal Brexit – In The UK And EU27?

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?

Medical Device Europe

UK Industry Skeptical Of Govt’s No-Deal Brexit Filing Expectations

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.

United Kingdom Brexit

BIA ‘Reassured’ On Post-Brexit SPC Regime But Data Exclusivity Concerns Remain

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.

Brexit Intellectual Property

UK's NICE Rejects US Industry Attack On Its HTA Methods

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.”

Pricing Debate Reimbursement

Surprise As UK Notified Bodies Lose Major Part Of Their UK Role In Devices From March 29

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the services of EU27 notified bodies  with UK notified bodies set to have their conformity assessment roles temporarily withdrawn if the UK leaves on March 29 without a deal.

Medical Device Europe

To What Extent Are UK Medtech’s Ties With Rest Of World In Jeopardy Beginning March 29?

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?

Medical Device Europe

Europe’s Medicines Verification System Prepares To Go Live

Europe’s ambitious new system for verifying the authenticity of prescription medicines circulating on the market is about to come into operation.

Safety Regulation

UK Plan To Replace EFSA Post-Brexit Leaves Industry With Unanswered Questions

With the deadline looming for the UK to strike a Brexit agreement, industry groups Food Supplements Europe and CRN UK give their reactions to government plans to create a new Nutrition and Health Claims Committee to take on the role of EFSA in the event of a no deal.
Europe United Kingdom

PhRMA Wants US-UK Trade Deal To Cover Regulatory Alignment

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. 

Brexit Trade
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