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Filtering on: "geography europe"

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Regulatory Recon: J&J Halts Two Drugs in Development; Novartis to Close Colorado Manufacturing Site (17 October 2017) By Zachary Brennan - Published 17 October 2017

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

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

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

ICH Transparency: New Info on Funding, Expert Working Groups By Zachary Brennan - Published 17 October 2017

The International Council for Harmonisation (ICH) on Monday began a push toward more transparency, with the release of which members make up its expert working groups and new data on how ICH is funded.

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

Tags: ICH funding, E9, E11, S5

EMA Plots Out Priorities to Deal With Brexit Uncertainties By Zachary Brennan - Published 16 October 2017

The European Medicines Agency (EMA) on Monday released its Brexit Preparedness Business Continuity Plan, saying it will prioritize its core scientific activities, including urgent and significant public health threats relating to the safety and quality of medicinal products for human and veterinary use in the EU.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Crisis management, Drugs, Postmarket surveillance

Tags: Brexit, EMA business continuity

EMA Responds to BMJ Article Questioning Benefits of Recent Cancer Drug Approvals By Zachary Brennan - Published 13 October 2017

As more cancer drugs are approved and prices continue to rise, questions have circulated on whether these drugs are extending patient survival or improving quality of life (QoL).

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: cancer drug approvals, QoL, survival benefit

European Regulatory Roundup: Brexit Sparks Hiring Drive at Danish Medicines Agency (12 October 2017) By Nick Paul Taylor - Published 12 October 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, Medical Devices

Tags: European Regulatory Roundup, Brexit

FDA Warns Swedish IVD Manufacturer By Zachary Brennan - Published 10 October 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 20 September to Malmo, Sweden-based Euro Diagnostica AB, which manufactures multiple class II in vitro diagnostic (IVD) devices.

Categories: News, Europe, US, CDRH, Compliance, Due Diligence, In vitro diagnostics, Medical Devices, Quality

Tags: FDA warning letters, IVD manufacturer warning letter, Euro Diagnostica

European Commission Adopts Two Acts on GMPs for Medicines By Zachary Brennan - Published 10 October 2017

Last month, the European Commission adopted two legal acts seeking to improve patient safety through good manufacturing practices (GMP) that ensure the highest quality of medicines for investigational and human use.

Categories: News, Europe, EC, Biologics and biotechnology, Drugs, Manufacturing

Tags: good manufacturing practices, implementing directive, delegated regulation, GMPs for investigational medicines

EMA Preps for Staff Shortages, Possible 'Major' Budget Deficit By Zachary Brennan - Published 06 October 2017

Although the new European Medicines Agency's (EMA) location will not be known until November, EMA on Friday said again that it's anticipating heavy staff losses which will not only challenge its operability but "could also result in a major deficit in its budget," according to highlights published Friday from a management board meeting this month.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Crisis management, Drugs, Due Diligence, Government affairs

Tags: Brexit, EMA staff shortages, EMA headquarters

European Regulatory Roundup: Swissmedic Pilots Changes to Accelerate Drug Authorizations (5 October 2017) By Nick Paul Taylor - Published 05 October 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

Tags: accelerated approval, Swissmedic, CQC, Guido Rasi

Global Reimbursement Strategy, Advertising, Labeling and Marketing, and a Preview of Health Related Foods By Gloria Hall - Published 04 October 2017

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in October.

Categories: Features, Canada, Europe, US, FDA, Health Canada, MHRA, NICE, Advertising and Promotion, Labeling, Nutritional and dietary supplements, Reimbursement

Tags: Regulatory Focus, Feature Articles, Editorial

FDA Offers New ICH Guidance on Organizing a CTD By Zachary Brennan - Published 04 October 2017

The US Food and Drug Administration (FDA) this week released a guidance that is part of a series from the International Council of Harmonisation (ICH) on the format for preparing the Common Technical Document (CTD) for applications submitted to FDA.

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

Tags: eCTD, common technical document, ICH guidance

EMA Makes Final Preparations Ahead of New EudraVigilance Launch By Michael Mezher - Published 04 October 2017

With the 22 November launch date for its revamped EudraVigilance system rapidly approaching, the European Medicines Agency (EMA) on Wednesday provided some last minute updates on what to expect during the transition to the new system.

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

Tags: EudraVigilance, Pharmacovigilance, ICSRs, SUSARs, Adverse Event Reporting

Germany Reimbursement Profile By Elvira Müller, PhD, MPH - Published 03 October 2017

This profile summarizes the reimbursement process in Germany, presents responsibilities for key stakeholders and highlights issues for consideration early in the development process.

Categories: Features, Europe, Drugs, Medical Devices, Reimbursement, Submission and registration

Tags: G-BA, IQWiG, GKV-SV, InEK

IMDRF Consults on Use of Registries to Support Device Approval Decisions By Zachary Brennan - Published 02 October 2017

The International Medical Device Regulators Forum (IMDRF) has opened for consultation until 1 December a third document on examining the use of registries to support medical device regulatory decision making.

Categories: News, Asia, Canada, Europe, US, IMDRF, In vitro diagnostics, Medical Devices, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: registry data and medical devices, medical device data, approval decisions and registries

Abbvie, Amgen Deal on Humira Biosimilars Likely to Cost CMS More Than $1B By Zachary Brennan - Published 02 October 2017

Late last week, Amgen and AbbVie settled litigation over when competition for the world’s best-selling biologic Humira (adalimumab) will hit the market, and for the US, the settlement decided on 31 January 2023, while the EU will see competition 16 October 2018.

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

Tags: AbbVie, Amgen, Humira, biosimilar, CMS

European Regulatory Roundup: EMA Overrode Pharma Concerns in Adopting First-in-Human Guideline (28 September 2017) By Nick Paul Taylor - Published 28 September 2017

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

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

Tags: European Regulatory Roundup, EU Regulatory Roundup, Regulatory Roundup

Spain Reimbursement Profile By Jesús Cuervo, PhD, Carlos Crespo, MBA, MHE, PhD, Jenifer Ehreth, MHA, PhD - Published 27 September 2017

This profile summarizes the reimbursement process in Spain, presents key stakeholders and highlights what should be considered early in the development process.

Categories: Features, Europe, Biologics and biotechnology, Drugs, Medical Devices, Reimbursement

Tags: Spain, AEMPS, Agencia Española de Medicamentos y Productos Sanitarios

EMA Warns of Major Staff Losses in HQ Relocation By Michael Mezher - Published 26 September 2017

The European Medicines Agency (EMA) on Tuesday warned that it could lose a majority of its staff based on which of the 19 cities vying to host the medicines regulator is selected by the European Council in November.

Categories: News, Europe, EC, EMA

Tags: Brexit, EMA Headquarters, Relocation

New E&Y MedTech Report Highlights Growth, Regulatory Questions By Zachary Brennan - Published 25 September 2017

Ernst & Young on Monday released a new report on how the global medical technology (medtech) industry grew by 5% in 2016, with US and EU medtech companies seeing net income increase 17%, though several regulatory question marks are on the horizon.

Categories: News, Asia, Europe, US, In vitro diagnostics, Medical Devices

Tags: medtech report, medtech income, medtech regulations

European Regulatory Roundup: Medtech Industry Pressures Brexit Negotiators to Maintain UK-EU Relationship (21 September 2017) By Nick Paul Taylor - Published 21 September 2017

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

Categories: News, Europe, EMA, MHRA, Biologics and biotechnology, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: European Regulatory Roundup, Brexit, biosimilar switching, vaccines

EMA Explains Early Industry Engagements Following EU Ombudsman's Questions on Bias By Zachary Brennan - Published 21 September 2017

Following an inquiry into the perception of bias in early interactions between the biopharma industry and the European Medicines Agency (EMA), EMA executive director Guido Rasi tried to assure the EU ombudsman that the risk of bias is manageable.

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

Tags: EU ombudsman, early regulator engagement, pre-submission meetings

France Reimbursement Profile By Jenifer Ehreth, MHA, PhD - Published 20 September 2017

This profile summarizes the reimbursement process, presents key stakeholders in France and highlights complexities to be considered early in the development process.

Categories: Features, Europe, Biologics and biotechnology, Drugs, Medical Devices, Reimbursement

Tags: ANSM, ACAM, CEESP, CEPS, Reimbursement, France

UK’s MHRA Unveils Human Factors Guidance for Medical Devices By Zachary Brennan - Published 19 September 2017

As part of its work to minimize the risks from use error and promote safe practices, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released new guidance on human factors and usability engineering for medical device manufacturers.

Categories: News, Europe, EC, MHRA, Combination products, Government affairs, In vitro diagnostics, Medical Devices

Tags: human factors guidance for medical devices, MHRA guidance, MDR

England Reimbursement Profile By Vishal Patel - Published 18 September 2017

This profile summarizes the reimbursement process in England, presents key stakeholders and highlights what should be considered early in the development process.

Categories: Features, Europe, MHRA, NICE, Biologics and biotechnology, Drugs, Reimbursement

Tags: NICE, NHS, Reimbursement

EMA Finds No Difference in Inhibitor Risk Between Factor VIII Classes By Michael Mezher - Published 18 September 2017

The European Medicines Agency (EMA) on Friday said it could find "no clear and consistent" evidence of a difference in the risk of inhibitor development between recombinant and plasma-derived factor VIII medicines.

Categories: News, Europe, EMA, Biologics and biotechnology, Blood

Tags: Factor VIII, Inhibitor, Hemophilia A