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Set Alert for Brexit

UK Agency Boss Hudson Leaves Brexit Challenge To Successor

A new leader is needed for MHRA as UK agency CEO Ian Hudson announces he'll leave next September. Someone else will have to reshape and guide the agency after Brexit.
Europe Brexit Regulation

Health Must Be At Center Of Post-Brexit Relationship, Say Industry & NHS Bodies

UK industry and National Health Service bodies say that the “political declaration” on the future UK-EU relationship fails to address key public health issues such as regulatory cooperation, collaboration in science and innovation, and tackling counterfeit medicines.
Brexit Regulation Europe

Latest From 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

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services of EU27 notified bodies  with UK notified bodies set to have their conformity assessment roles temporarily withdrawn if the UK leaves on March 29 without a deal.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

BSI Touts 'Very Short' Waiting Times For Migrating Certificates From UK To Netherlands

With a growing urgency for medtech manufacturers to take decisive action so their products are not banned from the market under an increasingly likely no-deal Brexit, clients of BSI will be relieved to hear their notified body believes time is on their side.

Medical Device Europe
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