Search Results for

Filtering on: "geography europe"

Showing 1 – 25  of 900

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

French Regulators Set Up Dedicated Unit for Overseeing Early Stage Clinical Trials By Michael Mezher - Published 11 December 2017

France's Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) last week announced that it is setting up a new unit dedicated to overseeing first-in-human and other early stage clinical trials.

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

Tags: First-in-Human, Clinical Trials, ANSM, Bial

IPRF and IGRP Merge to Become the International Pharmaceutical Regulators Programme  By Zachary Brennan - Published 08 December 2017

With an aim toward better exchanging information and avoiding duplication, the International Pharmaceutical Regulators Forum (IPRF) and International Generic Drug Regulators Programme (IGDRP) initiatives will merge as of the first of next year and be known as the International Pharmaceutical Regulators Programme (IPRP), according to notes from the IPRF's management committee meeting in Geneva on 12-13 November.

Categories: News, Asia, Canada, Europe, US, ICH, Biologics and biotechnology, Drugs

Tags: IGDRP, IPRF,

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

As EU Regulations Undergo Major Changes, RAPS Publishes Updated Essential Regulatory Affairs Reference By Zachary Brousseau - Published 06 December 2017

RAPS has published the updated, eighth edition of Fundamentals of EU Regulatory Affairs, the most extensive reference available on regulatory affairs for pharmaceuticals, medical devices, biologics and other healthcare products intended for the European market.

Categories: HTML, Articles, Under RAPS, Europe

Tags: Fundamentals of Regulatory Affairs, Europe

Merck and PhRMA to FDA: Wait for ICH Before Finalizing Guidance on Toxicity Testing for Cancer Drugs By Zachary Brennan - Published 04 December 2017

Drugmakers and industry groups are calling on the US Food and Drug Administration (FDA) to hold off on finalizing a draft guidance until the International Council on Harmonisation (ICH) finalizes its own guidance on the topic of reproductive toxicity testing for oncology drugs.

Categories: News, Europe, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: cancer drugs, toxicity

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

FDA Approves Eighth Biosimilar, First for Cancer Drug Herceptin By Zachary Brennan - Published 01 December 2017

The US Food and Drug Administration (FDA) on Friday approved the first biosimilar to Roche’s breast and stomach cancer drug Herceptin (trastuzumab). Mylan and Biocon’s biosimilar is called Ogivri (trastuzumab-dkst) and follows a back and forth of delays with regulators over manufacturing issues at a plant in India.

Categories: News, Canada, Europe, US, FDA, Biologics and biotechnology

Tags: Herceptin, biosimilar, FDA approval

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

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

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

IGDRP Offers Guidance for Quality Assessors on Drug Substances By Zachary Brennan - Published 28 November 2017

The International Generic Drug Regulators Programme (IGDRP) on Tuesday released guidance finalized in June to help regulatory agencies’ quality assessors review technical information on active substances.

Categories: News, Canada, Europe, ICH, Drugs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: IGDRP, international regulation, drug substance

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

Why Don't EMA and FDA Speak With the Same Voice on Flu Treatments? Researchers Investigate By Zachary Brennan - Published 13 November 2017

New research published last week digs into cross-national regulatory divergences, with a focus on why some US labels for certain flu treatments say the medicines have not been proven to reduce complications while EU labels claim the opposite.

Categories: News, Europe, US, EMA, FDA, Clinical, Drugs, Government affairs

Tags: Relenza, Tamiflu, regulatory divergence

EMA, EUnetHTA Sign Off on Three-Year Work Plan By Michael Mezher - Published 13 November 2017

The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) on Monday detailed their priorities for the next three years in a joint work plan.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Reimbursement, Submission and registration

Tags: EUnetHTA, HTA, Health Technology Assessment, Parallel Advice

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

Nearly Half of Recent EU Approvals Based on a Single Pivotal Study By Michael Mezher - Published 10 November 2017

A recent study found that 45% of marketing authorizations granted in the EU from 2012 to 2016 were based on evidence from a single pivotal trial.

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Clinical, Drugs, Regulatory strategy

Tags: Pivotal Trials, Single Pivotal Study

EMA Backs Six Drugs, One Biosimilar for EU Approval By Michael Mezher - Published 10 November 2017

The European Medicines Agency (EMA) on Friday said that its Committee for Medicinal Products for Human Use (CHMP) is recommending six new drugs, a biosimilar and three generic medicines for EU approval.

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

Tags: Marketing Authorization Applications, CHMP, Accelerated Assessment, Orphan Designation, Biosimilar, Jorveza, Prevymis, Ocrevus, Adynovi, Fasenra, Intrarosa, Mvasi

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

EMA Offers Support for More Research on DIVI Biomarkers By Zachary Brennan - Published 09 November 2017

European Medicines Agency (EMA) Executive Director Guido Rasi this week sent a letter of support to the Safer and Faster Evidence-Based Translation (SAFE-T) Consortium and the Predictive Safety Testing Consortium (PSTC) to encourage further study of ways to monitor for drug-induced vascular injury (DIVI) in early clinical drug development.

Categories: News, Europe, US, EMA, FDA, Clinical, Government affairs, Research and development

Tags: Guido Rasi, DIVI biomarkers

Notified Bodies Disclose Re-Designation Intentions Ahead of EU MDR, IVDR Deadline By Zachary Brennan - Published 08 November 2017

European notified bodies are prepping for a 26 November deadline and announcing their intentions to apply for designation as implementation of the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) continues.

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

Tags: notified bodies, Team-NB, MDR, IVDR