Search Results for ENVI

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European Regulatory Roundup: EMA Explains its Regulatory System (14 September 2017) By Nick Paul Taylor - Published 14 September 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: HPRA, ENVI, CVMP, DKMA

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: 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

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

EU Parliament Committee Backs Report to Increase Access to Medicines By Zachary Brennan - Published 01 February 2017

The European Parliament’s Environment, Public Health and Food Safety (ENVI) committee on Tuesday backed a draft report calling on the commission to analyze the impact of intellectual property on pharmaceutical access, as well as review the regulatory framework for orphan medicines, among other provisions.

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

Tags: ENVI committee, EFPIA, HTA, medicines access

European Regulatory Roundup: Report Calls to Minimize Amount of Data Generated by Sponsors (28 November 2016) By Nick Paul Taylor - Published 28 November 2016

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

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

Tags: EU Regulatory Roundup, ENVI, CHMP, MDD

European Regulatory Roundup: Brexit Could Lead to New Regulatory Burdens (25 February 2016) By Nick Paul Taylor - Published 25 February 2016

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

Categories: News, Europe, EC, EMA, MHRA, NICE, Crisis management, Drugs, Government affairs, Preclinical, Veterinary products

Tags: EMA, Brexit, antibiotic use, ENVI, CVMP

European Regulatory Roundup: UK’s NICE Takes Sides in PCSK9 Market (11 February 2016) By Nick Paul Taylor - Published 11 February 2016

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

Categories: News, Europe, EMA, MHRA, NICE, Biologics and biotechnology, Drugs, Ethics, Government affairs, Regulatory intelligence, Regulatory strategy, Reimbursement, Veterinary products

Tags: NICE, Xarelto, Paluent, Sanofi, Amgen, ENVI

EU Considers Major Revisions to Veterinary Medicines Regulations By Michael Mezher - Published 13 March 2015

The European Parliament is considering major changes to how veterinary medical products are regulated in the EU.

Categories: Distribution, Postmarket surveillance, Submission and registration, Veterinary products

Tags: Veterinary Medicines, Environment Public health and Food Safety (ENVI), Antimicrobial Resistance

European Parliament Proposes Changes to Pharmacovigilance User Fee Collection System By Alexander Gaffney, RF News Editor - Published 23 October 2013

Tags: Draft Report, ENVI, User Fees, Latest News, EU, pharmacovigilance

Industry Group: EU Device Regulatory Proposals Would Cost 'Outrageous' €25 Billion By Alexander Gaffney, RF News Editor - Published 12 September 2013

Tags: ENVI, Eucomed, Latest News, EU, medical device

August Break Over, ENVI Returns to Consider Overhaul of EU Device, IVD Regulatory Frameworks By Alexander Gaffney, RF News Editor - Published 10 September 2013

Tags: ENVI, European Parliament, Latest News, IVD, regulation, EU, medical device

EU Parliament Prepares to Discuss Reauthorization of Two Regulatory-Focused Programs By Alexander Gaffney, RF News Editor - Published 29 August 2013

Categories: Europe

Tags: ENVI, EU

European Parliament Committee Says Changes to Proposed Device Legislation Needed By Alexander Gaffney, RF News Editor - Published 31 July 2013

Tags: ENVI, European Parliament, Report, EU, medical device

Draft IVD Proposal Would Strengthen Clinical Testing Requirements By Alexander Gaffney, RF News Editor - Published 17 April 2013

Categories: EC

Tags: IVDs, Proposal, ENVI, Legislation, Latest News, EU, medical device

In Unprecedented Shift, EU Parliament Proposes Premarket Authorization for Medical Devices By Alexander Gaffney, RF News Editor - Published 15 April 2013

Tags: ENVI, EU, medical device

Amended EU Clinical Trials Proposal Calls for Full Publication of Clinical Trials Data By Alexander Gaffney, RF News Editor - Published 05 February 2013

Categories: EC

Tags: Data Reporting, CRS, ENVI, EP, Transparency, Latest News, clinical trials, EU

Committee Calls for Improved Pharmacovigilance, New Labeling Requirements in Europe By Alexander Gaffney - Published 17 May 2012

Categories: Labeling

Tags: ENVI, European Parliament, Legislation, Latest News, marketing, committee, pharmacovigilance