Search Results for Brexit

Showing 1 – 25  of 27

UK on Brexit Implications: ‘Significant Benefits’ to Remain Part of EMA By Zachary Brennan - Published 14 March 2017

The UK government’s EU External Affairs Subcommittee on Tuesday published a report on the implications of Brexit on trade, noting that there may be “significant benefits” in continuing UK participation in the European Medicines Agency (EMA).

Categories: News, Europe, EC, EMA, MHRA, NICE, Biologics and biotechnology, Drugs

Tags: Brexit, UK in EMA, House of Lords

European Regulatory Roundup: House of Lords Backs Change to Drug Pricing Bill to Appease Pharma Industry (16 February 2017) By Nick Paul Taylor - Published 16 February 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Business and Leadership, Government affairs

Tags: European regulatory roundup, biosimilars, Brexit

European Regulatory Roundup: ENVI Calls to for EMA Budget Reserves in Case of Brexit Volatility (9 February 2017) By Nick Paul Taylor - Published 09 February 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Government affairs

Tags: European regulatory roundup, Brexit, ENVI, aripiprazole, Hospira

European Regulatory Roundup: Lead Brexiteer Muddies Waters on UK-EMA Relationship (2 February 2017) By Nick Paul Taylor - Published 02 February 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Brexit, Jeremy Hunt, David Davis, Guido Rasi

European Regulatory Roundup: UK to Seek ‘Closest Possible Regulatory Equivalence’ With EMA Post-Brexit (26 January 2017) By Nick Paul Taylor - Published 26 January 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, NICE, Biologics and biotechnology, Business and Leadership, Drugs, Government affairs, Medical Devices

Tags: European Regulatory Roundup, Brexit, Theresa May, NICE Chair

European Regulatory Roundup: The Netherlands Bids to Host EMA (20 January 2017) By Nick Paul Taylor - Published 20 January 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Medical Devices

Tags: European Regulatory Roundup, Brexit

NICE Halts Plans to Charge for Appraisals By Zachary Brennan - Published 16 January 2017

The UK’s National Institute of Health and Care Excellence (NICE) on Monday said its plans to charge companies for its appraisals of drugs, medical devices and diagnostics have been put on hold until the UK’s new government completes its life sciences strategy.

Categories: News, Europe, EMA, MHRA, NICE, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Reimbursement

Tags: Brexit, UK Life Sciences, ABPI, NICE

Top Ten Stories From 2016 by Traffic By Zachary Brennan - Published 23 December 2016

Thanks to our readers this year for continuing to tune in on a daily basis. Here’s a rundown of the top 10 stories from 2016, a smorgasbord of randomness based on traffic. Happy holidays and happy reading!

Categories: News, Europe, US, EC, EMA, FDA, Biologics and biotechnology, Drugs, Medical Devices

Tags: 2016 top 10 list, Brexit, Trump, FDA guidance

EMA Board Signs Off on 2017 Budget as Brexit Questions Linger By Zachary Brennan - Published 19 December 2016

The European Medicines Agency (EMA) on Monday announced that its management board signed off on a slightly increased 2017 budget as preparations for the UK’s departure from the EU continue.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: EMA and Brexit, EMA budget, EMA transparency

European Regulatory Roundup: Lead Brexiteer Dismisses Need for UK to Stay in EU Regulatory System (10 November 2016) By Nick Paul Taylor - Published 10 November 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Ethics, Government affairs, Medical Devices

Tags: Brexit, Big Data, regulatory science, social media, adverse event reporting

EMA's Rasi on Brexit: Climate of Uncertainty Straining Worker Motivation By Zachary Brennan - Published 08 November 2016

At a meeting of the European Parliament’s Committee on the Environment, Public Health and Food Safety on Tuesday, the European Medicines Agency’s Executive Director Guido Rasi said the agency needs additional measures to support its staff as the uncertainty over Brexit is taking its toll on staffers.

Categories: News, Europe, EC, EMA, Drugs, Government affairs, Quality, Regulatory intelligence, Regulatory strategy

Tags: European Parliament, Guido Rasi, Brexit

MHRA: UK an Active Member of EU Networks ‘Until we Left the EU’ By Zachary Brennan - Published 03 November 2016

In its annual accountability review, the UK’s Medicines & Healthcare products Regulatory Agency told the Parliamentary Under Secretary of State for Health that the UK “remained an active member of EU regulatory networks until we left the EU.”

Categories: News, Europe, MHRA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

Tags: MHRA, Brexit, EU regulatory networks

Ireland Looks to Host New EMA Headquarters Following Brexit By Zachary Brennan - Published 26 October 2016

Ireland’s Minister for Health Simon Harris has confirmed that Ireland will formally bid to host the European Medicines Agency (EMA) headquarters in the aftermath of Brexit.

Categories: News, Europe, EMA, Due Diligence, Regulatory intelligence, Regulatory strategy

Tags: EMA headquarters, Brexit

European Regulatory Roundup: EMA to Discuss Future of Adaptive Pathways Program (15 September 2016) By Nick Paul Taylor - Published 15 September 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Clinical, Drugs, Government affairs, Manufacturing

Tags: European Regulatory Roundup, Brexit, adaptive pathways, Emer Cooke

Japan’s Ministry of Foreign Affairs: Don’t Move EMA Headquarters From London By Zachary Brennan - Published 06 September 2016

If the European Medicines Agency (EMA) transfers its headquarters to another EU member state, which is all but certain following the Brexit vote, Japan’s Ministry of Foreign Affairs is warning that the “appeal of London as an environment for the development of pharmaceuticals would be lost.”

Categories: News, Japan, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Government affairs, Quality, Regulatory intelligence, Regulatory strategy, Research and development

Tags: EMA, Brexit, UK approval of drugs

European Regulatory Roundup: UK Lord Tries to Reassure Politicians on Brexit Life Science Strategy (11 August 2016) By Nick Paul Taylor - Published 11 August 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: European Regulatory Roundup, Brexit, immunotherapy, mAb

European Regulatory Roundup: EMA to Revise Trial Guidance on Hemophilia, Crohn’s, Ulcerative Colitis, Diabetes and Bipolar Disorder (4 August 2016) By Nick Paul Taylor - Published 04 August 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, NICE, Biologics and biotechnology, Drugs, Government affairs, Labeling, Quality

Tags: hemophilia, ulcerative coilitis, Crohn's disease, diabetes, bipolar disorder, Brexit

Brexit Rejig: UK Taps Three Leaders to Helm Office for Life Sciences By Zachary Brennan - Published 04 August 2016

The UK’s Office for Life Sciences, which will continue to be a joint unit across the Department of Health (DH) and the newly formed Department for Business, Energy, and Industrial Strategy (BEIS), on Thursday selected three new ministers to lead.

Categories: News, Europe, EMA, MHRA, NICE, Biologics and biotechnology, Drugs, Government affairs

Tags: Brexit, UK Office for Life Sciences, GlaxoSmithKline

EMA to Cut One Drug Division, Strengthen Collaborations With National Competent Authorities By Zachary Brennan - Published 29 July 2016

As the European Medicine Agency (EMA) prepares to relocate its headquarters from London, thanks to the Brexit vote, the agency is also restructuring as part of what it says will be a leaner, more streamlined architecture that builds on the overhaul from 2013 and 2014.

Categories: News, Europe, EMA, Drugs, Government affairs

Tags: EMA and Brexit, Brexit, EMA in London

Brexit Creating a Period of Uncertainty for EU, UK Drug and Device Regulators By Zachary Brennan - Published 28 June 2016

The fallout from the UK referendum is continuing to create strife among the ranks of the European Medicines Agency (EMA), though a top EMA official told the DIA annual conference on Tuesday in Philadelphia that business at the agency will carry on as usual as negotiations continue.

Categories: News, Europe, EMA, FDA, MHRA, Drugs, Government affairs, Medical Devices, Research and development

Tags: Brexit, UK drug legislation, UK drug regulations, DIA conference 2016

MHRA Mulling Brexit Implications as UK’s BSI Says it Will Remain an EU Notified Body By Zachary Brennan - Published 27 June 2016

The UK’s drug and medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), said Monday it is still working to understand the full ramifications of the country’s departure from the EU.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Brexit, BSI, Notified Body, EU Referendum

Regulatory Recon: Brexit Fallout: How Will MHRA and EMA Handle the Split? (24 June 2016) By Michael Mezher - Published 24 June 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News, EU Referendum, Brexit

Brexit Conundrum: How Does MHRA Work With EMA Moving Forward By Zachary Brennan - Published 24 June 2016

With the UK deciding by referendum to leave the EU, the vote will have major implications for the regulation of medicines and medical devices across the entire continent.

Categories: News, Europe, EC, EMA, MHRA, NICE, Drugs, Government affairs, Medical Devices, Postmarket surveillance

Tags: Brexit, UK regulation of medicines, regulation of drugs after Brexit

European Regulatory Roundup: MHRA Offers Draft Guidance on Device and Combo Products (16 June 2016) By Nick Paul Taylor - Published 16 June 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Quality, Regulatory strategy

Tags: Brexit, draft guidance, PSURs

European Regulatory Roundup: MHRA, UK Biopharma Industry Warn Against Brexit (12 May 2016) By Nick Paul Taylor - Published 12 May 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.  

Categories: News, Europe, EC, EMA, MHRA, Crisis management, Government affairs, Quality

Tags: European Regulatory Roundup, EMA, MHRA, Brexit, UK biopharmaceuticals