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EMA survey identifies gaps in pharma industry's preparedness for Brexit

An EMA survey has identified gaps in the pharmaceutical industry’s preparedness for Brexit, finding that only 58% of market authorisation holders are on track with their regulatory planning in preparation for the UK’s exit from the European Union in March 2019.  

The survey, aimed at identifying centrally authorised products (CAPs) that are at risk of shortages following Brexit, identified that for 16% of the medicines surveyed, there are serious concerns the necessary procedures will not be carried out in time.

Brexit negotiations: Is the public’s health a priority?

Published on 12/06/18 at 11:22am

The Brexit decision has created a huge amount of question marks for many industries and each is vying with each other for the ear of the UK Government. Ben Hargreaves states the case that, for the public’s health, the healthcare and life science industries should be at the front of the queue.

The June 2018 issue of Pharmafocus is now live!

The new June edition of Pharmafocus is now available to read online.

Top Ten most popular articles on Pharmafile.com this week

It's a special Firday here in Europe, as today marks the advent of the General Data Protection Regulation (GDPR), an important step in recognising the rights of citizens to their own data. It also marks the print date of our upcoming June issue, whcih will include a special feature on the topic of the moment: data management.

Clinical trials, Brexit and the question of ‘full alignment’

Published on 21/05/18 at 11:13am

Gene Matthews, Partner at Leigh Day, reviews the tough decisions the UK has to make regarding its position in the EU regulatory framework post-Brexit.

There is a real and significant risk that the UK is in danger of being out of step with the EU post-Brexit. The term ‘third country’ is used in the EU Treaties to describe a country that is not a member of the EU. In practical terms, this will mean that the UK will not be party to EU legislation. The UK will become a third country on 29 March 2019.

Top Ten most popular articles on Pharmafile.com this week

The year is flying by - it's another Friday, and that means another Top Ten run-down.

Perhaps the biggest story this week was that Novartis found itself at the centre of controversy again, as it emerged that the company had paid a massive $1.2 million to Donald Trump's lawyer Michael Cohen in the hopes of meeting the President to gain some insight into the direction his administration would be likely to move in. But things didn't go to plan.

EMA initiates divorce process from the UK’s MHRA

The first stage of separation for the EMA from the UK came with the decision to relocate its headquarters to Amsterdam, and now the second stage has taken place whereby the EMA has reassigned the MHRA’s role vetting medicines to other countries.

All of this has been brought about by Brexit; the surprise decision to go ahead with uncoupling the EMA’s medicine verification process from the MHRA immediately after the deadline for Brexit will have brought even more uncertainty for UK industry.

Top Ten most popular articles on Pharmafile.com this week

As we approach the Easter weekend, we at Pharmafocus hope all of our readers have a great long weekend, if you're lucky enough to benefit from one. That also means that this week's Top Ten comes a little earlier than usual.

Brexit Health Alliance: Brexit and the impact on patient access to medicines

Published on 28/03/18 at 09:01am

On behalf of the Brexit Health Alliance, Sarah Collen, Senior Policy Manager at NHS Confederation, details the potential negative fallout from the UK’s decision to leave the EU.

The Brexit Health Alliance believes the UK’s plans to leave the EU and the EU’s single market could have serious implications for patients’ access to medicines. This article will explore how UK and EU citizens could be affected by the disruption in trade that could result from the UK’s exit from the EU.

Six reasons why UK pharma has more to gain, than fear, from Brexit

Published on 26/03/18 at 11:02am

There are good reasons to think exiting the EU represents a major opportunity for this dynamic and world-leading industry, argues Tom Cowap of Catalyst Corporate Finance.

Those who fear Brexit spells disaster for the UK’s pharmaceuticals sector can rest easy. Not only is there every reason to be confident in the sector’s ability to flourish after the UK has left the EU, but Brexit will deliver a positive boost.

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