Search Results for

Filtering on: "organizations agencies/organizations ema"

Showing 1 – 25  of 948

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 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

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

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

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

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

More Efficient Rare Pediatric Drug Development: FDA Drafts Guidance By Zachary Brennan - Published 06 December 2017

The US Food and Drug Administration (FDA) on Wednesday released draft guidance that could speed the development of treatments for rare pediatric disease drugs.

Categories: News, US, EMA, FDA, Clinical, Drugs

Tags: rare pediatric disease, Gaucher, FDA draft guidance

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

FDA, EMA and PMDA Plot Harmonized Path for Antibiotics By Michael Mezher - Published 17 November 2017

Regulators from the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), met in Tokyo last month to plot out an approach that would allow drugmakers to conduct a single development plan for new antibiotics.

Categories: News, EMA, FDA, PMDA, Clinical, Drugs, Preclinical

Tags: Antimicrobial Resistance, AMR, Antibiotics, Harmonization

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

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

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