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Filtering on: "geography europe"

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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

Brexit: MHRA Promises 'No Sudden Changes' to UK Regulations By Michael Mezher - Published 16 January 2018

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday reassured drugmakers that there will be no sudden changes to the country's regulatory framework when it leaves the EU in March 2019.

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

Tags: Brexit

ICMRA Looks to Make Track-and-Trace Systems Globally Interoperable By Zachary Brennan - Published 11 January 2018

The International Coalition of Medicines Regulatory Authorities (ICMRA) is focusing on aligning existing and planned track and trace systems worldwide, with an eye toward interoperability as many of the existing and planned systems were designed with a national or regional focus.

Categories: News, Asia, Europe, US, EMA, FDA, MHRA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Quality, Regulatory intelligence

Tags: ICMRA, track and trace, interoperability

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

EMA Adopts Guideline on Clinical Trials for Rheumatoid Arthritis Treatments By Zachary Brennan - Published 10 January 2018

The European Medicines Agency (EMA) on Wednesday announced the adoption of a guideline, first drafted in 2011, on the clinical evaluation of medicinal products in the treatment of the autoimmune disease rheumatoid arthritis (RA).

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

Tags: rheumatoid arthritis, EMA guideline

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 Recon: Biopharma and Legislative Questions for 2018 (2 January 2018) By Zachary Brennan - Published 02 January 2018

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

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

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

Regulatory Strategies for OTC Switch Programs, Implementing EU MDR & IVDR and a Preview of January By Gloria Hall - Published 22 December 2017

Feature articles over the past several weeks provided background, approaches, regulatory considerations, and strategies for implementing prescription to Over-the-Counter (Rx-to-OTC) switch programs; CE marking requirements of IVD medical devices under the new EU regulation; explanation of Annex I general requirements and essential requirements; implementation strategies for the new EU medical devices regulations; and medical device classification rules, manufacturer registration procedures, dossier filing procedures, and pre-clinical and marketing application approval processes in India.

Categories: Features, India, Europe, US, Clinical, Over the counter drugs, Prescription drugs, In vitro diagnostics, Medical Devices

Tags: Feature Editorial

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

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

UK's MHRA: Apotex Site Does Not Comply With GMP Requirements By Zachary Brennan - Published 18 December 2017

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) found Apotex Research Private Limited's Bangalore, India-based manufacturing site to be noncompliant.

Categories: News, Asia, Europe, MHRA, Compliance, Crisis management, Due Diligence, Manufacturing

Tags: GMP requirements, Apotex, statement of noncompliance

EMA: Amsterdam HQ Won't Be Ready in Time for Move By Michael Mezher - Published 15 December 2017

The European Medicines Agency (EMA) on Friday said that its new headquarters in Amsterdam will not be complete until November 2019, eight months after the agency must move from its current offices in London.

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

Tags: Relocation, Brexit, Amsterdam, EMA HQ

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

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

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