Search Results for

Filtering on: "organizations agencies/organizations ema"

Showing 1 – 25  of 869

EMA Backs Eight New Medicines, Turns Down Drugs From Nektar & Vanda By Michael Mezher - Published 21 July 2017

The European Medicines Agency (EMA) on Friday recommended the approval of eight new medicines after its Committee for Medicinal Products for Human Use (CHMP) met to discuss the drugs earlier this week.

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

Tags: CHMP

EMA Recommends Suspending Certain Gadolinium Contrast Agents By Michael Mezher - Published 21 July 2017

The European Medicines Agency (EMA) on Friday said it plans to suspend the marketing authorization for three gadolinium contrast agents and restrict the use of others after a review by the agency's Pharmacovigilance Risk Assessment Committee (PRAC) confirmed evidence of gadolinium accumulation in patients' brains months after being injected.

Categories: News, Europe, EMA, Drugs

Tags: Gadolinium

European Regulatory Roundup: EU Watchdog Probes Whether Pre-Submission Meetings Enable Industry to Influence EMA (20 July 2017) By Nick Paul Taylor - Published 20 July 2017

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

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

Tags: EU Regulatory Roundup

EMA Updates Guidance on Three Post-Authorisation Activities By Michael Mezher - Published 14 July 2017

The European Medicines Agency (EMA) announced Friday it has updated three post-authorisation activity guidance documents, including type II variations, post-authorisation safety studies and quality variations.

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

Tags: Post-authorisation, Post-authorisation safety studies, Quality, Type II Variation

European Regulatory Roundup: New Pressure to Reverse Brexit Regulatory Split (13 July 2017) By Nick Paul Taylor - Published 13 July 2017

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

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

Tags: European Regulatory Roundup, Brexit, reimbursement

Regulatory Recon: FDA Reverses on Amicus’ Fabry Disease Treatment; Sanofi Acquires Protein Sciences (11 July 2017) By Zachary Brennan - Published 11 July 2017

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

Categories: News, Asia, Europe, US, EMA, FDA, MHRA, NICE, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

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

Regulatory Recon: UK Supreme Court Rules in Favor of Lilly Patents; HHS OIG Probes Alexion (7 July 2017) By Zachary Brennan - Published 07 July 2017

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

Categories: News, Asia, Canada, Europe, US, EC, EMA, FDA, MHRA, Biologics and biotechnology, Drugs, Medical Devices

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

EMA Restricts Use of Biogen MS Drug By Zachary Brennan - Published 07 July 2017

The European Medicines Agency (EMA) on Friday announced it is provisionally restricting the use of Biogen Idec’s multiple sclerosis (MS) medicine Zinbryta (daclizumab) to patients "with highly active relapsing disease that has failed to respond to certain other treatment, and to patients with rapidly evolving relapsing disease who cannot be treated with other medicines."

Categories: News, Europe, EMA, FDA, Drugs, Labeling, Postmarket surveillance

Tags: Biogen, MS, EMA PRAC

European Regulatory Roundup: New Gateway for Parallel Consultations on Marketing Authorizations, HTAs (6 July 2017) By Nick Paul Taylor - Published 06 July 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, Due Diligence, Regulatory intelligence, Regulatory strategy

Tags: EUnetHTA, type II variations, ATMPs

10 Years in, EU Pediatric-Use Marketing Authorization Called a 'Disappointment' By Zachary Brennan - Published 06 July 2017

Biopharmaceutical companies and regulators across Europe have said that in the 10 years since the Pediatric Regulation took effect, some pediatric therapeutic areas have seen progress, though the pediatric-use marketing authorization (PUMA) has not lived up to expectations.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Orphan products, Regulatory intelligence, Regulatory strategy

Tags: pediatric-use marketing authorisation, EMA and PUMA, pediatric drugs

Pediatric Legislation, Quality Certificates, Global Regulatory Oversight, Biosimilars and a Preview of July By Gloria Hall - Published 05 July 2017

Feature articles over the past several weeks have highlighted global pediatric activities, certificates for small molecule drug products, the New Drug Application (NDA) process in Egypt and the global debate over naming biological products and biosimilars.

Categories: Features, Africa, Asia, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, MHLW, TGA, WHO, Biologics and biotechnology, Clinical, Drugs, Medical Devices, Regulatory intelligence, Submission and registration

Tags: Regulatory Focus, Feature Articles

British Ministers Call for Post-Brexit Cooperation With EMA By Zachary Brennan - Published 03 July 2017

UK health minister Jeremy Hunt and business minister Greg Clark on Monday wrote a letter to the Financial Times calling for the UK to continue working with the European Medicines Agency after Brexit.

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

Tags: Brexit, Jeremy Hunt, EMA post-Brexit

EMA and FDA Look to Facilitate Development of Gaucher Disease Treatments By Zachary Brennan - Published 03 July 2017

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on Monday released a new strategy document to aid in the development of new treatments for Gaucher disease, a rare lysosomal storage disorder.

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

Tags: EMA and FDA, Gaucher disease, rare pediatric disease

European Regulatory Roundup: Swissmedic Proposes Overhaul of Drug Ordinances (29 June 2017) By Nick Paul Taylor - Published 29 June 2017

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

Categories: EC, EMA, MHRA, Drugs, Government affairs

Tags: Swiss drug ordinances, ICH E2E, CVMP

Biological Products and Biosimilars: Global Naming Debate By Pallavi Trivedi - Published 27 June 2017

This article presents the contrasting views and continuing debate among health authorities in Australia, Canada, Europe, Japan and the US as well as industry experts regarding conventions for naming biological products and biosimilars. It discusses the World Health Organization's (WHO's) proposal for naming and the importance of a clear distinction between the drugs to avoid confusion and ensure patient safety.

Categories: News, Asia, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, PMDA, TGA, WHO, Biologics and biotechnology, Submission and registration

Tags: Biosimilars, Biosimilar Naming, Biological Qualifier, INN

EMA Offers New EudraVigilance Checklist for Sponsors, MAHs By Zachary Brennan - Published 26 June 2017

The European Medicines Agency (EMA) on Monday published a checklist to help marketing authorization holders (MAHs) and sponsors prepare for the technical changes ahead of the launch of the new EudraVigilance adverse event system on 22 November 2017.

Categories: News, Europe, EMA, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: EudraVigilance, marketing authorisation holders, individual case safety reports

EMA Recommends New HCV, Cancer and MS Drugs for Approval By Michael Mezher - Published 23 June 2017

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday recommended eight new medicines for approval, including two pan-genotypic hepatitis C (HCV) drugs and a third biosimilar for AbbVie's Humira (adalimumab).

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

Tags: CHMP, Maviret, Vosevi, Imraldi

Decision on EMA Relocation Set for November, Council Agrees on Bidding Procedure By Michael Mezher - Published 23 June 2017

At the EU Summit in Brussels on Thursday, the European Council backed a procedure to determine where the European Medicines Agency (EMA) will be relocated to following the UK's withdrawal from the EU.

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

Tags: Brexit, EMA Relocation

European Regulatory Roundup: EMA Tasks Working Groups With Redistributing Workloads in Run Up to Brexit (22 June 2017) By Nick Paul Taylor - Published 22 June 2017

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

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

Tags: European Regulatory Roundup, Regulatory Roundup

Regulating CRISPR: FDA and Industry Offer Perspective By Zachary Brennan - Published 21 June 2017

Although the US market is likely more than a year or two away from seeing any commercialized medical products that rely on CRISPR-Cas9 technology, the rapidly developing field has already grabbed the attention of the US Food and Drug Administration (FDA) and other drug regulators.

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

Tags: CRISPR-Cas9, CRISPR regulation, FDA and CRISPR, Editas, Intellia, CRISPR Therapeutics

Application of EU Clinical Trial Regulation Delayed to 2019 By Zachary Brennan - Published 16 June 2017

The European Medicines Agency’s management board said that due to technical difficulties with the development of IT systems, the application of the clinical trial regulation has to be postponed.

Categories: News, Europe, EC, EMA, Clinical, Compliance, Government affairs

Tags: EMA clinical trial regulation, clinical trial regs, EMA portal

European Regulatory Roundup: ENVI Urges EC to Exclude Healthcare From Regulation of Professions (15 June 2017) By Nick Paul Taylor - Published 15 June 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, ENVI, antibiotics, PRAC

Identification of Medicinal Products (IDMP) Standards Part 4: Technical Approaches to IDMP By Dieter Schlaps - Published 12 June 2017

This article discusses IT approaches to support a gap analysis and implementation of the upcoming Identification of Medicinal Products (IDMP) standards with regard to generating, collecting and mapping accurate and correct data prior to submission in an effort to prevent delays in a product reaching the market.

Categories: Features, Europe, US, EMA, FDA, ISO, Biologics and biotechnology, Drugs

Tags: Identification of Medicinal Products, IDMP

EMA’s PRAC to Hold First Public Hearing on Use of Valproate Medicines By Zachary Brennan - Published 09 June 2017

The European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) will hold its first public hearing on 26 September 2017 to discuss the safety of using valproate-containing medicines in the treatment of various conditions for women and girls who are pregnant or of childbearing age. 

Categories: News, Europe, EMA, Drugs

Tags: valproate, pregnant women, PRAC

European Regulatory Roundup: EMA to Discuss Improving Treatment of Kids With Lymphoma, Leukemia (8 June 2017) By Nick Paul Taylor - Published 08 June 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, Medical Devices

Tags: European Regulatory Roundup, BASG, BfArM