Search Results for Brexit

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European Regulatory Roundup: Rise of Cell Therapies Prompts EC to Float Orphan Drug Changes (2 November 2017) By Nick Paul Taylor - Published 02 November 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, Regulatory intelligence, Regulatory strategy

Tags: cell therapies, Brexit, antimicrobial resistance

European Regulatory Roundup: UK Prime Minister Hints at Desire to Remain Part of EMA During Brexit Transition (26 October 2017) By Nick Paul Taylor - Published 26 October 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, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Theresa May, Brexit, antibiotics

European Regulatory Roundup: MHRA Chief Floats Faster Reviews, Closer Ties to NICE (19 October 2017) By Nick Paul Taylor - Published 19 October 2017

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

Categories: News, Europe, EMA, MHRA, Drugs, Regulatory intelligence, Regulatory strategy

Tags: Brexit, HPV vaccine, CHMP

EMA Plots Out Priorities to Deal With Brexit Uncertainties By Zachary Brennan - Published 16 October 2017

The European Medicines Agency (EMA) on Monday released its Brexit Preparedness Business Continuity Plan, saying it will prioritize its core scientific activities, including urgent and significant public health threats relating to the safety and quality of medicinal products for human and veterinary use in the EU.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Crisis management, Drugs, Postmarket surveillance

Tags: Brexit, EMA business continuity

European Regulatory Roundup: Brexit Sparks Hiring Drive at Danish Medicines Agency (12 October 2017) By Nick Paul Taylor - Published 12 October 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

Tags: European Regulatory Roundup, Brexit

EMA Preps for Staff Shortages, Possible 'Major' Budget Deficit By Zachary Brennan - Published 06 October 2017

Although the new European Medicines Agency's (EMA) location will not be known until November, EMA on Friday said again that it's anticipating heavy staff losses which will not only challenge its operability but "could also result in a major deficit in its budget," according to highlights published Friday from a management board meeting this month.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Crisis management, Drugs, Due Diligence, Government affairs

Tags: Brexit, EMA staff shortages, EMA headquarters

EMA Warns of Major Staff Losses in HQ Relocation By Michael Mezher - Published 26 September 2017

The European Medicines Agency (EMA) on Tuesday warned that it could lose a majority of its staff based on which of the 19 cities vying to host the medicines regulator is selected by the European Council in November.

Categories: News, Europe, EC, EMA

Tags: Brexit, EMA Headquarters, Relocation

European Regulatory Roundup: Medtech Industry Pressures Brexit Negotiators to Maintain UK-EU Relationship (21 September 2017) By Nick Paul Taylor - Published 21 September 2017

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

Categories: News, Europe, EMA, MHRA, Biologics and biotechnology, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: European Regulatory Roundup, Brexit, biosimilar switching, vaccines

European Regulatory Roundup: EU Committee Slams Plan to Cut EMA Staffing Ahead of Brexit (7 September 2017) By Nick Paul Taylor - Published 07 September 2017

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

Categories: News, Europe, EC, EMA, Drugs, Medical Devices

Tags: European Regulatory Roundup, Brexit, EMA staff cuts

European Regulatory Roundup: Industry Seeks Post-Brexit System Prioritizing Ties to EMA (31 August 2017) By Nick Paul Taylor - Published 31 August 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, Medical Devices

Tags: Brexit, medical device directives, PSUR

European Regulatory Roundup: New Pressure to Reverse Brexit Regulatory Split (13 July 2017) By Nick Paul Taylor - Published 13 July 2017

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

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

Tags: European Regulatory Roundup, Brexit, reimbursement

British Ministers Call for Post-Brexit Cooperation With EMA By Zachary Brennan - Published 03 July 2017

UK health minister Jeremy Hunt and business minister Greg Clark on Monday wrote a letter to the Financial Times calling for the UK to continue working with the European Medicines Agency after Brexit.

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

Tags: Brexit, Jeremy Hunt, EMA post-Brexit

Decision on EMA Relocation Set for November, Council Agrees on Bidding Procedure By Michael Mezher - Published 23 June 2017

At the EU Summit in Brussels on Thursday, the European Council backed a procedure to determine where the European Medicines Agency (EMA) will be relocated to following the UK's withdrawal from the EU.

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

Tags: Brexit, EMA Relocation

European Regulatory Roundup: EU Device Regulations Come Into Force; Swissmedic Clarifies Pharmacovigilance Process (1 June 2017) By Nick Paul Taylor - Published 01 June 2017

The European Union medical device and in-vitro diagnostic (IVD) regulations have come into force. The passing of the date marks the start of the phased, multi-year introductions of requirements set out in the two documents.

Categories: Europe, EC, EMA, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, Postmarket surveillance, Submission and registration

Tags: European Regulatory Roundup, Regulatory Roundup, EU Regulatory Roundup, Brexit, MDR, IVDR, Swissmedic, Pharmacovigilance,

European Commission and EMA Offer Guidance on Brexit for Pharma Companies By Zachary Brennan - Published 31 May 2017

As marketing authorisation holders (MAHs) based in the UK begin to form plans to transfer their marketing authorizations (MAs) to holders established in EU member states, Norway, Iceland and Liechtenstein, the European Medicines Agency (EMA) and European Commission on Wednesday released guidance to prepare industry for the UK’s withdrawal from the EU.

Categories: News, Europe, EC, EMA, Crisis management, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Brexit, QPPV, PSMF, batch release, orphan products, MAHs and Brexit

EMA Report on 2016: 27 New Drugs, New Priority Scheme, Trial Transparency By Zachary Brennan - Published 10 May 2017

With the European Medicines Agency’s (EMA) departure from London and loss of UK expertise (about 60 of the 897 EMA staffers are from the UK) looking more likely, the agency on Wednesday released a report outlining its successes from 2016, when 27 new medicines were authorized and several new programs took shape.

Categories: News, Europe, EC, EMA, Active pharmaceutical ingredients, Biologics and biotechnology, Clinical, Compliance, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: PRIME, Brexit, EMA in 2016

EMA to Pharma Companies: Prepare for UK to EU Shift By Zachary Brennan - Published 02 May 2017

Setting the stage for a likely exodus from the UK for pharmaceutical manufacturers and staff, the European Medicines Agency (EMA) on Tuesday notified marketing authorization holders (MAHs) that for centrally authorized products, EU law requires them to be established in the EU or European Economic Area, which includes Iceland, Liechtenstein and Norway.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Compliance, Drugs, Regulatory intelligence, Regulatory strategy

Tags: Brexit, pharmaceutical companies in UK, MAHs in UK

UK Pharmacovigilance Post-Brexit: Lots of Questions, Few Answers By Zachary Brennan - Published 01 May 2017

No one knows what UK pharmacovigilance will look like after the UK leaves the EU, and that uncertainty puts the many Qualified Persons Responsible for Pharmacovigilance (QPPV) residing in the UK in a precarious position.

Categories: News, Europe, EC, EMA, MHRA, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: Brexit, pharmacovigilance, Ian Hudson

EMA Plots Workload Shift Ahead of UK Experts' Departures in 2019 By Zachary Brennan - Published 28 April 2017

With a meeting yesterday between the European Medicines Agency's (EMA) Management Board and heads of the National Competent Authorities (NCAs) of the EU/EEA member states, a discussion was initiated on how to share the work of evaluating and monitoring medicines without the UK's help.

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

Tags: Brexit, EMA headquarters, EMA move

Pharma Execs Seek Smooth and Quick Transition of EMA Headquarters Out of London By Zachary Brennan - Published 24 April 2017

With an eye to avoiding public health issues during a transition period, executives from Novartis, Pfizer, Eli Lilly, Amgen and other companies are calling on the European Council to decide on the new headquarters location of the European Medicines Agency (EMA) “as early on as possibly, preferably at its meeting in June.”

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

Tags: Brexit, EMA headquarters

European Parliament Calls for Rapid Relocation of EMA Headquarters By Zachary Brennan - Published 06 April 2017

The European Parliament on Wednesday called for an agreement to be reached “as quickly as possible” to relocate the headquarters of the European Medicines Agency (EMA) following the UK’s decision to exit the EU.

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

Tags: Brexit, EMA, European Parliament, Kent Woods

UK Triggers Brexit: What’s Next for the UK, MHRA and EMA? By Zachary Brennan - Published 29 March 2017

UK Prime Minister Teresa May on Wednesday set in motion the UK’s departure from the EU over the next two years, guaranteeing the European Medicines Agency (EMA) will see some significant changes over the next few years.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Brexit, EMA, MHRA, new EMA headquarters

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