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Brexit

Set Alert for Brexit

UK To Seek Only Limited Regulatory Alignment With EU

Despite the life sciences industry’s call for continued alignment of medicines regulation with the EU from next year and for some sort of co-operation with the European Medicines Agency, it seems the UK government is prepared to make only small concessions.

United Kingdom Brexit Regulation

‘No Unified Patent Court For Us’, Says UK Government

The UK’s decision to pull out of Europe’s Unified Patent Court system throws the future of the whole project into doubt.

Europe United Kingdom Intellectual Property

Latest From Brexit

EU Regulatory Round-Up: RWE Platform Proposed, Brexit Transition Update, EPI Principles Published

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.  

Health OTC Drugs

UK’s Brexit Talks Another Victim Of Coronavirus – FTA Plans With EU Could Be In Jeopardy

The second round of the UK’s talks on exiting the EU by the end of the year have been called off over COVID-19, but whether this is a temporary derailment or a more structural issue for the UK’s planned EU separation is the question emerging.

Brexit United Kingdom

'Get Your Skates On', UK Firms Planning M&A Warned

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.

Companies Regulation

A Global Approach To Medtech Regulation: The Post-EU Way Ahead For UK Industry?

As the UK looks to its future healthtech regulatory model after Brexit, the ABHI’s regulatory director Phil Brown suggests a system whereby the same product data can be used as the basis for entry not only to the EU, but also to global markets.

United Kingdom Medical Device

UK Devices Bill Offers Medtech An EU MDR Alternative – Or Better?

With the obvious distractions of coronavirus, the UK Medicines and Medical Devices bill has entered its second reading in parliament, accompanied by a drive for it to succeed from the government and opposition parties.

United Kingdom Regulation

Back With A Bang: ‘Brexit Bill’ For UK’s Medical Devices Due For 2nd Reading On 2 March

Parliamentary debate next week on the post-Brexit regulatory adjustments ahead for the UK medical devices industry will coincide with the opening of post-Brexit EU trade talks by the UK government. After a period of nervous calm, Brexit will be back with a bang.

United Kingdom EU

Hunt On For New Chair Of UK Regulator

Whoever takes over as chair of the Medicines and Healthcare products Regulatory Agency will play a key role in its plans to deliver a program of “ambitious business change.”

United Kingdom Brexit

Hunt On For New Chair Of UK Regulator

Whoever takes over as chair of the Medicines and Healthcare products Regulatory Agency will play a key role in its plans to deliver a program of “ambitious business change.”

United Kingdom Brexit

Podcast: Living In China's Coronavirus Lockdown; Novartis and England's 'Public Health' Alliance; Biogen's Moment of Truth Approaches

Scrip's Brian Yang describes what life is like in China as the authorities battle to contain the coronavirus, and drug developers race to find vaccine and anti-virals against the new threat. Plus news on Novartis' bold initiative with England on inclisiran, and what lies ahead for Biogen and Alzheimer's treatment in 2020.

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