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Filtering on: "geography europe"

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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

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

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

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

WHO to Craft Essential Diagnostics List By Zachary Brennan - Published 16 June 2017

The World Health Organization (WHO) has received a recommendation from an expert committee to develop an Essential Diagnostics List (EDL).

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, Oceania, WHO, Due Diligence, Government affairs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: WHO essential diagnostics, EDL, Essential medicines list

6 Things You Need to Do to Prepare for the New EU Medical Devices Regulation By Paul Brooks - Published 15 June 2017

When the EU’s new Medical Devices Regulation (MDR) entered into force last month, it set in motion a three-year countdown to the new rules’ full application in 2020. For companies marketing devices in the EU that wish to continue to do so, there is a lot to do in that relatively short time, so it is critical to begin as soon as possible. Early preparation is key. Following are six things you should be doing to get ready.

Categories: Europe, EC, Medical Devices

Tags: Europe MDR, medical device regulation, new device regulations in Europe

NICE, Roche Reach Deal on Breast Cancer Drug By Michael Mezher - Published 15 June 2017

Patients in the UK could soon get access to Roche's targeted breast cancer drug Kadcyla (trastuzumab emtansine) through the National Health Service (NHS) as early as next month, the National Institute for Health and Care Excellence (NICE) said on Thursday.

Categories: News, Europe, NICE, Biologics and biotechnology, Reimbursement

Tags: NICE, Roche, Kadcyla, Herceptin, Trastuzumab

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

Regulatory Recon: Valeant to Sell Pharma Unit for $930M; South Korea to Fine Novartis Over Drug Promos (8 June 2017) By Zachary Brennan - Published 08 June 2017

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

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

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

UK Patients to get Early Access to Dompé's Oxervate By Michael Mezher - Published 07 June 2017

Patients in the UK will get early access to Dompé farmaceutici's neurotrophic keratitis drug Oxervate (cenegermin), the Medicines and Healthcare products Regulatory Agency (MHRA) announced Wednesday.

Categories: News, Europe, MHRA, Biologics and biotechnology

Regulating Pediatric Studies: An EU and US Perspective By Jennifer Sanguedolce, Narissa Mulchan - Published 05 June 2017

This article presents pediatric regulatory activities conducted by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) and highlights global harmonization efforts, collaborative discussions and regulations for pediatric clinical trials.

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

Quality Certificates for Small Molecule Drug Product Applications for International Regulatory Submissions By Monika Jain, PhD - Published 02 June 2017

This article provides a global overview of the general requirements and issues regulatory professionals may encounter while arranging for a variety of certificates for applications for small molecule drug products to be marketed internationally in the EU, US, Canada, Australia and Japan.

Categories: Features, Japan, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, PMDA, TGA, Drugs, Submission and registration

Tags: Quality Certificates, eCTD, GMP

EMA Consults on Regulatory Requirements for Chronic Liver Disease Drugs By Michael Mezher - Published 01 June 2017

The European Medicines Agency (EMA) on Thursday launched a public consultation to gather input on a future reflection paper discussing the regulatory requirements for developing drugs to treat chronic non-infectious liver diseases.

Categories: News, Europe, EMA, Clinical, Drugs, Research and development, Submission and registration

Tags: NASH, PCS, PBC, Liver Disease, Drug Development

European Regulatory Roundup: EU Device Regulations Come Into Force; Swissmedic Clarifies Pharmacovigilance Process (1 June 2017) By Nick Paul Taylor - Published 01 June 2017

The European Union medical device and in-vitro diagnostic (IVD) regulations have come into force. The passing of the date marks the start of the phased, multi-year introductions of requirements set out in the two documents.

Categories: Europe, EC, EMA, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, Postmarket surveillance, Submission and registration

Tags: European Regulatory Roundup, Regulatory Roundup, EU Regulatory Roundup, Brexit, MDR, IVDR, Swissmedic, Pharmacovigilance,

EMA Plots New Ways to Help Small and Medium-Sized Pharma Firms By Zachary Brennan - Published 31 May 2017

The European Medicines Agency (EMA) on Wednesday published an action plan for the next three years to help small and medium-sized pharmaceutical companies.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Due Diligence, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: small- and medium-sized pharmaceutical companies, EMA on SMEs

Regulatory Recon: FDA Approves First Strattera Generics; UK’s NICE Backs Keytruda (31 May 2017) By Zachary Brennan - Published 31 May 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Asia, Europe, US, EMA, FDA, Health Canada, NICE, TGA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

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

UK's NICE to Launch New Online Tool for Med Tech Developers Published 31 May 2017

The UK's National Institute for Health and Care Excellence (NICE), which often determines if the UK can afford to pay for certain treatments, will launch a new online tool in July to help developers of medical devices and diagnostics understand how to generate the evidence necessary to show their products are clinically and cost effective.

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

Tags: NICE, medical technologies, medical devices, cost effectiveness of medical tech

Conditional Approvals for Early Access to New Medications By Sharry Arora - Published 31 May 2017

This article provides insight into Conditional Approvals (CAs) and Conditional Marketing Approvals (CMAs) as developed across several jurisdictions to potentially provide earlier access to new medicines. The author explains the specifics regarding regulatory requirements for obtaining CAs in the European Union (EU), Japan and the US.

Categories: Features, Japan, Europe, US, EMA, FDA, ICH, PMDA, Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration

Tags: Conditional approval, Regenerative medicine

European Commission and EMA Offer Guidance on Brexit for Pharma Companies By Zachary Brennan - Published 31 May 2017

As marketing authorisation holders (MAHs) based in the UK begin to form plans to transfer their marketing authorizations (MAs) to holders established in EU member states, Norway, Iceland and Liechtenstein, the European Medicines Agency (EMA) and European Commission on Wednesday released guidance to prepare industry for the UK’s withdrawal from the EU.

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

Tags: Brexit, QPPV, PSMF, batch release, orphan products, MAHs and Brexit