Search Results for EU

Showing 1 – 25  of 296

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 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

RAPS and Industry Experts Join Forces for Dedicated MDR Workshop By RAPS Staff - Published 18 May 2017

RAPS is bringing together a panel of Europe’s top industry experts to deliver a dedicated workshop on the new EU regulations for medical devices and in vitro diagnostic devices.

Categories: HTML, Articles, Under RAPS, Europe, RAPS

Tags: EU, Medical Device Regulations, IVD Regulations

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

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

European Regulatory Roundup: EMA Drafts Guidelines on Controlling False Positives in Clinical Trials (6 April 2017) By Nick Paul Taylor - Published 06 April 2017

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, Government affairs

Tags: EU clinical trials, trial endpoints, EMA guideline

UPDATE: RAPS Seeks Authors for EU Fundamentals Book; Deadline Extended By RAPS Staff - Published 30 March 2017

RAPS currently is seeking chapter authors for the upcoming eighth edition of Fundamentals of EU Regulatory Affairs.

Categories: HTML, Articles, Under RAPS, RAPS

Tags: EU regulatory affairs, EU, European Union, Europe

European Regulatory Roundup: EMA Reports Year-Long Shortage of BMS Kidney Transplant Drug; UK Rejects Indication-Specific Drug Pricing (23 March 2017) By Nick Paul Taylor - Published 23 March 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, Reimbursement, Veterinary products

Tags: EU Regulatory Roundup, European Regulatory Roundup, Regulatory Roundup

EU Council Unanimously Adopts MDR, IVDR: Next Stop EU Parliament By Michael Mezher - Published 07 March 2017

The EU's new rules governing medical device and in vitro diagnostics (IVDs) are one step away from being fully adopted.

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

Tags: Medical Device Regulations, MDR, In Vitro Diagnostics Regulations, IVDR, EU Council

New Report Investigates Drivers of Off-Label Prescribing in the EU By Zachary Brennan - Published 03 March 2017

A lack of incentives to go through the marketing authorization process to extend certain drug labels, as well as pricing and reimbursement issues, were cited as some of the varied drivers of off-label prescription drug use in the EU, according to a new report from the European Commission.

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

Tags: EU, off-label drugs, off-label prescribing

European Regulatory Roundup: EMA Recommends Approval of First Monoclonal Antibody Veterinary Medicine (23 February 2017) By Nick Paul Taylor - Published 23 February 2017

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

Categories: News, EMA, MHRA, Advertising and Promotion, Biologics and biotechnology, Drugs, Veterinary products

Tags: EU Regulatory Roundup, Regulatory Roundup, European Regulatory Roundup

EMA Touts Growth of Post-Authorisation Study Database By Michael Mezher - Published 13 February 2017

The European Medicines Agency (EMA) on Friday announced it has published more than 1,000 post-authorization studies in a public online database.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs, Postmarket surveillance

Tags: Post-Authorisation Studies, PAS, EU PAS Register

European Regulatory Roundup: EMA Releases Draft Guidance on Using Pictograms on Packaging (1 December 2016) By Nick Paul Taylor - Published 01 December 2016

The European Medicines Agency (EMA) has posted draft guidance on the use of approved pictograms on veterinary medicinal product packaging. EMA has drafted the document to create a harmonized set of pictograms marketing authorization holders (MAHs) can use to communicate effectively in the limited space available on product packaging.

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

Tags: EU Regulatory Roundup, Regulatory Roundup, European Regulatory Roundup

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

EMA Revises Guideline on First-in-Human Trials By Zachary Brennan - Published 15 November 2016

The European Medicines Agency (EMA), in cooperation with the European Commission and the EU member states, on Tuesday proposed revisions to its 2007 guideline on first-in-human clinical trials as part of an effort to further improve the safety of participants as trial protocols become increasingly complex.

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

Tags: first in human trials, clinical trial guidance, EU clinical trials, Bial, clinical trial guideline

EMA Recommends Nine Drugs for Approval By Zachary Brennan - Published 11 November 2016

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced it recommended nine medicines for approval at its meeting earlier this week, including four new treatments, three biosimilars and two generics.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Due Diligence, Quality, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: EMA CHMP, marketing authorisation in EU, Gilead, Sanofi, Novo Nordisk

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

European Regulatory Roundup: Sweden Lays Groundwork for Adoption of Adaptive Approval Pathway (3 November 2016) By Nick Paul Taylor - Published 03 November 2016

The Medical Products Agency (MPA) of Sweden has published a report ahead of an anticipated uptick in the use of the adaptive approval pathway in Alzheimer's disease and other indications. MPA wants to set up working groups to solve issues it identified with the application of the model to Alzheimer's, while also taking steps to involve patients more in the process.

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

Tags: European Regulatory Roundup, EU Regulatory Roundup, Regulatory Roundup

European Regulatory Roundup: Brexit Czar Plans 'Standardized' Approval Processes After Leaving EU (13 October 2016) By Nick Paul Taylor - Published 13 October 2016

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

Categories: News, Europe, EMA, MHRA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Medical Devices, Submission and registration

Tags: EU Regulatory Roundup, Regulatory Roundup, European Regulatory Roundup

EMA Board Signs Off on New Medicines Web Portal By Zachary Brennan - Published 10 October 2016

The European Medicines Agency’s (EMA) management board on Monday announced that it’s given the go-ahead for a new European medicines web portal, which will look to provide wider access to free, reliable and unbiased information on all medicines authorized in the EU.

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

Tags: EMA web portal, web portal on medicines, EU website on authorised medicines

European Regulatory Roundup: Proposal for a European Drug Pricing Initiative (6 October 2016) By Nick Paul Taylor - Published 06 October 2016

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

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

Tags: EU Regulatory Roundup, drug pricing, cancer drugs fund

EC Report Calls for New Network of Reference Labs for Human Pathogens By Zachary Brennan - Published 03 October 2016

The European Commission is calling for a formally defined EU-wide system for reference laboratory networks for human pathogens as the benefits are likely to outweigh the costs, according to an analysis of such a system released on Friday.

Categories: News, Europe, EC, Crisis management, Government affairs, In vitro diagnostics

Tags: reference laboratories, human pathogens, EU network of reference labs

EMA Contests Two Judicial Decisions Over Clinical Trial Transparency Efforts By Zachary Brennan - Published 29 September 2016

The European Medicines Agency (EMA) on Thursday announced it has appealed two interim orders by the President of the General Court of the EU, which suspended the release of clinical study documents requested by third parties under a new transparency regulation.

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

Tags: DMD drugs, PTC Therapeutics, clinical trial transparency, President of the General Court of the EU

European Regulatory Roundup: UK to Increase Regulatory Oversight of Antibiotics (22 September 2016) By Nick Paul Taylor - Published 22 September 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

Tags: EU, antibiotics, HTA, marketing authorisation

European Regulatory Roundup: EU Council Presidency to Prioritize Drug Availability; Eisai, IQWiG Clash Over Halaven (8 September 2016) By Nick Paul Taylor - Published 08 September 2016

The Slovak presidency of the EU Council of Ministers has identified improvements to the availability of drugs as a top priority for its time at the head of the organization. Slovakia is setting the agenda at the Council until the end of the year, giving it several months in which to advance its ambitions.

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

Tags: European Regulatory Roundup, EU Regulatory Roundup, Regulatory Roundup