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Filtering on: "organizations agencies/organizations ec"

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Regulatory Recon: Government Shutdown Looms; First PARP Inhibitor Approved in Japan (19 January 2018) By Zachary Brennan - Published 19 January 2018

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

Categories: News, 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: MHRA Rolls Out Online Portal to Streamline Medical Device Regulatory Services (18 January 2018) By Nick Paul Taylor - Published 18 January 2018

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

Tags: kidney, MHRA portal

EMA Begins Publishing Reports on Whether Approved Medicines Still Qualify as Orphans By Michael Mezher - Published 17 January 2018

The European Medicines Agency (EMA) on Wednesday announced it has begun publishing reports detailing its decision-making on whether newly approved drugs to treat rare diseases still qualify for orphan designation when they receive marketing authorization.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Orphan products, Submission and registration

Tags: Orphan Medicine Assessment

European Regulatory Roundup: Swissmedic Updates Biosimilar Guidance (11 January 2018) By Nick Paul Taylor - Published 11 January 2018

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, Swissmedic, biosimilars, multi-dose containers

European Commission Updates Borderline Device Classification Manual By Michael Mezher - Published 08 January 2018

The European Commission (EC) last week released an update to its manual on classifying "borderline" medical devices featuring clarifications as to the medical device status and classification of on twelve additional types of products.

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

Tags: Borderline Products, MDR, IVDR

European Regulatory Roundup: France Targets 80% Biosimilar Penetration by 2022 (4 January 2018) By Nick Paul Taylor - Published 04 January 2018

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

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

Tags: biosimilars, HPRA, Brexit, orphan drugs

Regulatory Challenges for Direct-to-Patient Clinical Trials By Andrea Zobel - Published 22 December 2017

On-site clinical trials may present a number of participation obstacles for individuals living at distances from clinical trial sites or for patients with mobility problems. Direct-to-patient clinical trials can be an alternative. This article reviews applicable regulations and analyzes current strategies for conducting direct-to-patient clinical trials using technologies, such as mobile 'apps' and wearables to report data, as well as the potential for sending trial drugs directly to participants. The author recommends ways to improve the regulatory landscape for direct-to-patient clinical trial participation and provides examples of best practices for working with regulatory agencies to ensure the efficacy and success of such trials.

Categories: Features, Europe, US, EC, EMA, FDA, ICH, Clinical, Drugs

Tags: Clinical Trials, Good Clinical Practice, Data Privacy, Direct-to-Patient Trials

European Regulatory Roundup: Roche Escapes Penalty for Breaching EU Pharmacovigilance Rules (21 December 2018) By Nick Paul Taylor - Published 21 December 2017

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

Categories: News, Canada, EC, EMA, MHRA, WHO, Biologics and biotechnology, Drugs, Postmarket surveillance, Veterinary products

Tags: EU Regulatory Roundup, Roche, Gates Foundation

EMA: Pharmacovigilance Fees to Rise in 2018 By Michael Mezher - Published 20 December 2017

The European Medicines Agency (EMA) on Wednesday said it expects fees paid by drugmakers for pharmacovigilance applications to rise by 1.4% in mid-January 2018.

Categories: News, Europe, EC, EMA, Drugs, Postmarket surveillance

Tags: Pharmacovigilance, Fees

European Commission Consults on Revised GMPs for Sterile Drugs By Michael Mezher - Published 20 December 2017

The European Commission on Wednesday launched a three-month public consultation ahead of its planned revision to good manufacturing practice (GMP) rules for sterile medicinal products contained in Annex 1 of Eudralex Volume 4.

Categories: News, Europe, EC, Drugs, Manufacturing

Tags: Eudralex Volume 4, Annex 1, Sterile Drugs, Good Manufacturing Practice, GMP

Best of 2017: What Readers Clicked on This Year By Zachary Brennan - Published 20 December 2017

From Trump to biosimilars to a new digital health pilot run by the US Food and Drug Administration (FDA), here are the top 10 most-read articles of 2017, with some updates on what has occurred since the stories were published.

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

Tags: Trump, biosimilars, Micro Therapeutic Research Labs, Truvada

European Regulatory Roundup: Critical Moment for EMA (15 December 2017) By Nick Paul Taylor - Published 15 December 2017

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

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

Tags: European Regulatory Roundup, Brexit, pediatric rare disease

Overview of Annex I, In Vitro Diagnostic Directive and the new In Vitro Diagnostic Regulation By Yvonne Middlefell, FRAPS, RAC - Published 12 December 2017

This article provides an overview of Annex I, Essential Requirements 98/79/EC and helps clarify understanding of the new content of Annex I, General Safety and Performance Requirements. It is aimed at regulatory professionals who will benefit from having knowledge of In Vitro Diagnostic Medical Devices General Requirements and Essential Requirements (ERs) as well as requirements for risk management, software, labeling, self-testing devices and instructions for use.

Categories: Features, Europe, EC, In vitro diagnostics, Labeling, Medical Devices, Submission and registration

Tags: IVDR, Annex 1, Risk Management

European Regulatory Roundup: EU Stands Firm on Demand for UK to Pay for EMA’s Exit (7 December 2017) By Nick Paul Taylor - Published 07 December 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: Brexit, PRAC, orphan drugs

Implementing the New EU Medical Devices Regulations By Randolph Fillmore - Published 01 December 2017

This article discusses the steps toward implementing the new EU regulations on medical devices with a focus on better pre-market control, establishing oversight and data systems. It is based on a presentation given by Salvatore Scalzo at the RAPS EU Regulatory Essentials Workshop held in Brussels, Belgium in July 2017.

Categories: Features, Europe, EC, In vitro diagnostics, Medical Devices

Tags: MDR, IVDR

CE Marking of In Vitro Diagnostic Medical Devices Under the New EU Regulation By Jonathan Bray, PhD, Michelle O'Connor, PhD, Robert D. Cumming - Published 01 December 2017

This article explains the revised classification rules, conformity assessment procedures and new requirements for clinical evidence to support the safety and performance of an In Vitro Diagnostic (IVD) medical device. Of significance, the In Vitro Diagnostic Device Regulations (EU 2017/746) transition from the prior two class system under the IVD Directive (98/19/EC) to a four-class, risk-based classification system.1 The regulations, intended to affect greater IVD safety and reliability, expand the definition of an IVD to include software used as any part of an IVD, as well as an IVD used for providing information concerning the predisposition to a medical condition or disease. An IVD also may be a device used to predict a treatment response or reaction to a treatment. Moving forward, all Class B through Class D IVDs will require some level of conformity assessment by an independent Notified Body.

Categories: Features, Europe, EC, Clinical, In vitro diagnostics, Medical Devices, Submission and registration

Tags: MDR, IVDR, CE Marking

March 2019: EMA Updates Guidance on Brexit By Zachary Brennan - Published 01 December 2017

The European Medicines Agency (EMA) and the European Commission on Friday updated guidance for pharmaceutical companies on the UK’s departure from the EU, much of which hinges on March 2019 deadlines.

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

Tags: Brexit

European Regulatory Roundup: EMA’s Rent Bill at €448M (30 November 2017) By Nick Paul Taylor - Published 30 November 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, Amsterdam EMA, Brexit

EMA Offers Guidance on Post-Brexit Changes as Industry Groups Call for Transition Period By Zachary Brennan - Published 28 November 2017

The European Medicines Agency (EMA) on Tuesday outlined the requirements that companies should follow when they apply for changes to their marketing authorization to allow for the continued marketing of their medicine in the European Economic Area (EEA) after the UK withdraws from the EU.

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

Tags: Brexit, EFPIA

EMA Headquarters to Move to Amsterdam By Zachary Brennan - Published 20 November 2017

The European Council on Monday voted to move the European Medicines Agency’s (EMA) headquarters and nearly 900 staffers from London to Amsterdam – a move that’s expected to begin tomorrow and finish 30 March 2019.

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

Tags: EMA relocation, EMA move, EMA headquarters, Milan EMA

European Regulatory Roundup: EFPIA Warns of Insufficient Time to Move Marketing Authorizations Before Brexit (17 November 2017) By Nick Paul Taylor - Published 17 November 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, EU Regulatory Roundup

The Medical Device Coordination Group: a new Authority Under EU Device Regulations By Robert D. Cumming, Nancy W. Mathewson, Esq. - Published 14 November 2017

This article discusses the organization and functions of the Medical Device Coordination Group (MDCG) established under the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). The article explains how both groups will be important players in the conformity assessment body 'notification' process and in determining how notified bodies assess and certify devices and in serving as a reviewing body for making regulatory and jurisdictional decisions for the European Commission.

Categories: Features, Europe, EC, In vitro diagnostics, Medical Devices

Tags: MDR, IVDR, Medical Device Coordination Group, MDCG

MDR, IVDR: Competent Authorities Lay Out Road Map By Zachary Brennan - Published 13 November 2017

The Competent Authorities for Medical Devices (CAMD) Executive Group’s EU medical device regulation and in vitro diagnostic regulation (MDR/IVDR) implementation task force has released a road map outlining key challenges and steps for various technical work streams.

Categories: News, Europe, EC, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: MDR, IVDR, CAMD

Eight Key Steps Toward EU-MDR Implementation By Gert Bos - Published 13 November 2017

This article offers eight steps toward ensuring compliance with the new European Union Medical Device Regulations. It is based on the author's presentation given in July 2017 on "EU Regulatory Essentials, Medical Device, and In Vitro Diagnostics: Transitioning From Current Directives to new Regulations" at the RAPS Brussels Conference.1, 2

Categories: Features, Europe, EC, In vitro diagnostics, Medical Devices, Submission and registration

European Regulatory Roundup: ex-GSK CEO to Chair UK Accelerated Access Collaborative (9 November 2017) By Nick Paul Taylor - Published 09 November 2017

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

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

Tags: GSK, accelerated access, DKMA, Celgene