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Application of EU Clinical Trial Regulation Delayed to 2019 By Zachary Brennan - Published 16 June 2017

The European Medicines Agency’s management board said that due to technical difficulties with the development of IT systems, the application of the clinical trial regulation has to be postponed.

Categories: News, Europe, EC, EMA, Clinical, Compliance, Government affairs

Tags: EMA clinical trial regulation, clinical trial regs, EMA portal

6 Things You Need to Do to Prepare for the New EU Medical Devices Regulation By Paul Brooks - Published 15 June 2017

When the EU’s new Medical Devices Regulation (MDR) entered into force last month, it set in motion a three-year countdown to the new rules’ full application in 2020. For companies marketing devices in the EU that wish to continue to do so, there is a lot to do in that relatively short time, so it is critical to begin as soon as possible. Early preparation is key. Following are six things you should be doing to get ready.

Categories: Europe, EC, Medical Devices

Tags: Europe MDR, medical device regulation, new device regulations in Europe

European Regulatory Roundup: ENVI Urges EC to Exclude Healthcare From Regulation of Professions (15 June 2017) By Nick Paul Taylor - Published 15 June 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, ENVI, antibiotics, PRAC

European Regulatory Roundup: EMA to Discuss Improving Treatment of Kids With Lymphoma, Leukemia (8 June 2017) By Nick Paul Taylor - Published 08 June 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: European Regulatory Roundup, BASG, BfArM

Regulatory Recon: Valeant to Sell Pharma Unit for $930M; South Korea to Fine Novartis Over Drug Promos (8 June 2017) By Zachary Brennan - Published 08 June 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

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

European Commission: Cranberry Products Are Not Medical Devices By Zachary Brennan - Published 26 May 2017

The European Commission's regulatory committee on medical devices on 19 May voted in favor of the commission's decision that products "whose principal intended action, depending on proanthocyanidins (PAC) present in cranberry extract, is to prevent or treat cystitis," also known as bladder inflammation or infection, "are not medical devices within the meaning of Article 1 (2) (a) of the Medical Devices Directive."

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

Tags: cranberries, UTIs, bladder infections, medical devices and cranberries

European Regulatory Roundup: Merck Accused of Blocking Remicade Biosimilars (25 May 2017) By Nick Paul Taylor - Published 25 May 2017

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

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

Tags: Remicade biosimilar, ENVI, whistleblowers

Regulatory Recon: FDA Approves New Rheumatoid Arthritis Treatment; Alexion C-Suite Overhaul (23 May 2017) By Zachary Brennan - Published 23 May 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Asia, Europe, US, EC, EMA, FDA, Health Canada, TGA, WHO, Biologics and biotechnology, Drugs, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

EMA to Launch Revamped EudraVigilance System to Monitor Adverse Events By Zachary Brennan - Published 22 May 2017

The European Medicines Agency’s (EMA) management board on Monday endorsed the launch on 22 November 2017 of an improved system for collecting and monitoring suspected adverse events.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: EudraVigilance, ICSR, adverse events, marketing authorisation holders

European Regulatory Roundup: Commission Begins Investigation Into Cancer Drug Prices (18 May 2017) By Nick Paul Taylor - Published 18 May 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, EU roundup of pharma news, Aspen, personalized medicine, ANSM

EU Health Tech Assessments: Majority Favor Continuing Beyond 2020 By Zachary Brennan - Published 15 May 2017

A majority of respondents to a European Commission questionnaire says health technology assessment (HTA) cooperation at the EU level should continue beyond 2020.

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

Tags: HTA, health technology assessments, European Commission report

European Regulatory Roundup: EMA Issues Increasing Number of GMP Non-Compliance Statements in India (11 May 2017) By Nick Paul Taylor - Published 11 May 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, Regulatory intelligence, Regulatory strategy

Tags: European regulatory roundup, PRAC, GMP inspections, flu vaccine guidance

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

Biosimilars in the EU: New IMS Report Shows Savings Through Competition By Zachary Brennan - Published 09 May 2017

A new report released Tuesday, prepared by QuintilesIMS at the request of the European Commission, found EU countries are saving lots of money from biosimilars even if market share is low.

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

Tags: biosimilars, biologic competition, anti-TNF, HGH

Final EU MDR, IVDR Texts Published, Countdown to Implementation Begins By Zachary Brennan - Published 05 May 2017

The final texts of the new European medical device and in vitro diagnostic (IVD) regulations were published on Friday in the Official Journal of the European Union, setting in motion the timeline for implementation of the new regulations, which is set to commence on 25 May.

Categories: News, Europe, US, EC, In vitro diagnostics, Medical Devices

Tags: EU MDR, IVDR, new medical device regulations, Europe regulations

European Regulatory Roundup: UK Hurries Drug Pricing Bill Ahead of Election (4 May 2017) By Nick Paul Taylor - Published 04 May 2017

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

Categories: News, Europe, EC, EMA, Drugs

Tags: drug pricing, ANSM, UK election

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

Impact of the Revised EU Clinical Trial Regulation By Siegfried Schmitt, Federico Bonacci, MD, Daniela Lisini, PhD, Dr. Viviana Mascilongo - Published 24 April 2017

Clinical Trial Regulation EU No 536/2014 will come into effect in 2018. This article reports on aspects of the revised regulation and evaluates its potential impact on clinical trials conducted to assess medicinal products for human use. It discusses changes impacting the critical role of the Ethics Committees in the approval process for clinical trials as well as the planned, centralized data reporting channel, referred to as "the portal." While revisions to the regulation are still underway, readers will benefit from the assessment of its current status and anticipated developments.

Categories: Features, Europe, EC, EMA, Biologics and biotechnology, Clinical, Drugs

Tags: Clinical Trial Regulation, EU No 536/2014

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

Regulatory Recon: Biotech M&A Falls Off; E&C Presses HHS on Pandemic Flu Plan (21 April 2017) By Zachary Brennan - Published 21 April 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Asia, Europe, US, EC, EMA, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

MHRA Plans for the Future of Drug, Device Regulation Post-Brexit By Zachary Brennan - Published 21 April 2017

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday released a business plan for the upcoming year, noting its primary focus on developing a consensus around a proposed model for the future of the country’s regulation of medicines and medical devices following its departure from the EU.

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

Tags: UK MHRA business plan, UK medical devices, pharmaceutical regulations