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Set Alert for Brexit

Parliament Tells PM To Take 'All Necessary Steps' To Keep UK In EMA After Brexit

Members of parliament in the UK want the government to take "all necessary steps" to keep the country in the EU medicines regulatory network after Brexit. It's not that easy, though.

Europe Brexit Regulation

Long-Awaited Brexit White Paper Lays Out UK’s Plans For Medicines Regulation

The UK government has finally published its white paper on the UK’s future relationship with the EU following Brexit, to the relief of the pharmaceutical industry.
Brexit Regulation Europe

Latest From Brexit

UK Medtechs' Brexit Readiness Moves Up A Notch In Absence Of EU Deal Framework

The UK is unmistakeably in the period of the calm before the storm, and an enforced Brexit lull is in place. But the thoughts of UK and EU decision-makers – and UK medtech companies – are not straying too far from the upcoming trade deal negotiations and the business of making the best of Brexit, however and whenever it manifests itself.

EU United Kingdom

UK Promises ‘Competitive’ Clinical Trial Process Whatever The Brexit Outcome

The UK pharmaceutical industry has welcomed government guidance on the clinical trial regulatory landscape after Brexit, as well as a report from Cancer Research UK on the need to preserve alignment with the EU’s Clinical Trial Regulation.
Clinical Trials Brexit

Industry Told How To Categorize And Group Brexit-Related Manufacturing Changes

The EU group for coordinating drug approvals through the mutual recognition and decentralized procedures has developed a non-exhaustive list of scenarios that companies with manufacturing processes in the UK may face following Brexit, and explains how to address these through appropriate variation applications. 
Europe Brexit

UK MHRA Makes Statements On Brexit Implementation Period – But On Shaky Ground?

The UK and EU27 medtech industries are desperate for information about what to do to prepare for Brexit. The UK medtech regulator has issued documents that might give insight, but there are still no certainties on the horizon.

Europe United Kingdom

UK Regulatory Changes During A Brexit Transition Period – The Government Explains All

Guidance documents on the regulation of medicines in the UK during a Brexit transition period have been published by the government, covering areas like batch release, drug approvals, and the role of the UK MHRA in the EU regulatory system.

Brexit United Kingdom

Pharma Firms Need To Pressure Politicians On Brexit Priorities

Pharmaceutical companies need to get their message over to MPs and MEPs about the risks of Brexit to medicines supply chains, and would do well to work more closely with patient groups to highlight the possible health risks of reduced access to medicines.

Brexit United Kingdom

EU Regulatory Reads, July 2018: Doubts Grow About Implementing New Regs In Time

Stakeholders are focusing on timing as implementation deadlines for the EU's new medtech regulations look increasingly unmanageable. Brexit is yet another complication that continued to catch Medtech Insight readers' attention in July, based on a look at the top 10 EU regulatory stories from last month.

Medical Device Europe

BSI Gives Clients Until March 31 To Submit For Recertification Under EU Directives

In an urgent notice to clients, notified body BSI warns that time is running out to recertify against the current EU directives, as pressures mount for all notified bodies.

Medical Device Europe

Brexit Bites EMA: Huge Staff Losses Freeze Many Projects

The EMA is halting its cherished transparency initiative on study data as it reckons with the fact that many of its employees will not be relocating to its new headquarters in Amsterdam. International collaboration, guidelines development and revision, and the agency's involvement in stakeholder meetings will all be cut back.

Europe Brexit
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