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Filtering on: "geography europe"

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EMA Reveals List of Eligible Industry Stakeholder Organizations By Zachary Brennan - Published 16 January 2017

The European Medicines Agency (EMA) on Monday disclosed a new list of eligible industry stakeholder organizations that can consult and cooperate with the agency in specific areas.

Categories: News, Europe, EC, EMA, Business and Leadership, Government affairs

Tags: drug industry stakeholders

NICE Halts Plans to Charge for Appraisals By Zachary Brennan - Published 16 January 2017

The UK’s National Institute of Health and Care Excellence (NICE) on Monday said its plans to charge companies for its appraisals of drugs, medical devices and diagnostics have been put on hold until the UK’s new government completes its life sciences strategy.

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

Tags: Brexit, UK Life Sciences, ABPI, NICE

Analysis: Longer Review Times Associated With Fewer Adverse Events for High-Risk Heart Devices By Michael Mezher - Published 13 January 2017

A new analysis finds longer regulatory review times for high-risk cardiovascular medical devices to be associated with fewer adverse event reports, and a lower likelihood of such reports citing serious injury or death.

Categories: News, Europe, US, EC, FDA, Medical Devices, Postmarket surveillance, Submission and registration

Tags: Adverse Event Reports, AER, Safety

European Regulatory Roundup: EMA Maps International Regulatory Coordination (12 January 2017) By Nick Paul Taylor - Published 12 January 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: regulatory harmonization, ICMRA, Bayer, biologic quality standards

FDA and MHRA Break Down Foreign Inspection Data By Zachary Brennan - Published 11 January 2017

Both the US Food and Drug Administration (FDA) and the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) are slowly ramping up their inspections of foreign manufacturers, according to the latest statistics.

Categories: News, Europe, US, FDA, MHRA, Biologics and biotechnology, Drugs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: foreign drug inspections, foreign device inspections

EMA Releases Q&A on Exposure Limits and Hazardous Compounds By Zachary Brennan - Published 09 January 2017

The European Medicines Agency (EMA) on Monday released for public consultation a new question and answer document focused on the risk-based prevention of cross contamination in pharmaceutical manufacturing and setting health-based exposure limits for risk identification.

Categories: News, Europe, EMA, Drugs, Preclinical

Tags: hazardous drug compounds, EMA guidance, HBELs

International Generic Drug Regulators Outline Plans for Collaboration Through 2020 By Zachary Brennan - Published 09 January 2017

As further cross-border harmonization among pharmaceutical regulators takes shape, the International Generic Drug Regulators Programme (IGDRP) has laid out its priorities that will take the group through the next four years.

Categories: News, Africa, Asia, Canada, Europe, US, Anvisa, CFDA, EC, EMA, FDA, Health Canada, ICH, Medsafe, MHLW, PMDA, TGA, WHO, Generic drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: generic drug regulation, COFEPRIS, DMFs, ASMFs

Regulatory Recon: Big Ruling Against Sanofi and Regeneron; Obama on Repealing Obamacare (6 January 2017) By Zachary Brennan - Published 06 January 2017

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

Categories: News, Canada, Europe, US, EC, EMA, FDA, Health Canada, NICE, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

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

Danish Regulator Suspends Parallel Importer's GMP Certificate By Michael Mezher - Published 06 January 2017

The Danish Medicines Agency has suspended Danish parallel importer Europharma DK's manufacturing authorisation and good manufacturing practice (GMP) certificate over "serious breaches of compliance" uncovered during an inspection of the company's Esbjerg, Denmark site last month.

Categories: News, Europe, Compliance, Distribution, Drugs, Packaging

Tags: Danish Medicines Agency, Europharma DK

European Commission Clears up Questions on Orphan Drug Regulation By Michael Mezher - Published 05 January 2017

Following a public consultation in November 2015, the European Commission (EC) has released a new communication intended to clarify some lingering questions about the EU's Orphan Regulation.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Orphan products

Tags: Orphan Regulation, Orphan Drugs, Orphan Designation

European Regulatory Roundup: Swissmedic Clarifies Stance on EC Certificates for Devices (5 January 2016) By Nick Paul Taylor - Published 05 January 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, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Swissmedic, European Regulatory Roundup, notified bodies, Braille

European Regulatory Roundup: EMA Reviews Drugs Tested at Two Indian Sites (23 December 2016) By Nick Paul Taylor - Published 23 December 2016

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

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

Tags: European Regulatory Roundup, CHMP, GCP

Top Ten Stories From 2016 by Traffic By Zachary Brennan - Published 23 December 2016

Thanks to our readers this year for continuing to tune in on a daily basis. Here’s a rundown of the top 10 stories from 2016, a smorgasbord of randomness based on traffic. Happy holidays and happy reading!

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

Tags: 2016 top 10 list, Brexit, Trump, FDA guidance

Regulatory Recon: Teva Settles Foreign Bribery Charges for $519M; Former HHS Officials on Trump’s Pick for HHS (22 December 2016) By Zachary Brennan - Published 22 December 2016

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

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

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

Identification of Medicinal Products (IDMP) Standards Part 1: Impact on the Regulatory World By Dieter Schlaps - Published 21 December 2016

This is part one of a four-part series on the Identification of Medicinal Products (IDMP) standards and their respective implementation guidelines. This segment reviews the steps needed to prepare for their global implementation and offers technical solution options for the industry.

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

Tags: ISO IDMP, IDMP, Identification of Medicinal Products

2016 in Review for Drug and Device Regulations: An 11th Hour Reckoning By Zachary Brennan - Published 20 December 2016

Turn back the clock to late October and those first 10 months of 2016 look like a relatively commonplace year for the pharma and medical device industries and their US regulatory counterpart, the US Food and Drug Administration (FDA) (on the EU side, Brexit was already causing headaches for the European Medicines Agency (EMA) as early as June).

Categories: News, Europe, US, EC, EMA, FDA, MHRA, Biologics and biotechnology, Compliance, Drugs, Government affairs, Labeling, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: pharmaceutical regulations, year in review, Cures, Trump

Spanish Regulator Cites Madrid Drugmaker for Manufacturing Violations By Michael Mezher - Published 20 December 2016

The Spanish Agency of Medicines and Medical Devices (AEMPS) has issued a statement of non-compliance to Madrid, Spain-based drugmaker Angulema, S.L., and ordered the recall of more than 400 lots of the company's vaccines.

Categories: News, Europe, Biologics and biotechnology, Manufacturing, Quality

Tags: AEMPS, Angulema

EMA Board Signs Off on 2017 Budget as Brexit Questions Linger By Zachary Brennan - Published 19 December 2016

The European Medicines Agency (EMA) on Monday announced that its management board signed off on a slightly increased 2017 budget as preparations for the UK’s departure from the EU continue.

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

Tags: EMA and Brexit, EMA budget, EMA transparency

Lessons Learned from Biosimilar Drug Development By Raymond A. Huml, MS, DVM, RAC, Nigel Rulewski, MD - Published 19 December 2016

This article discusses the emerging US biosimilars market, including critical success factors, safety issues, extrapolation, choice of reference product, partnerships and alliance management, clinical trial recruitment and regulatory and commercial factors. It also describes an accelerated approach to biosimilar clinical development.

Categories: Features, Europe, US, EMA, FDA, Biologics and biotechnology, Clinical, Preclinical, Regulatory strategy

Tags: Biosimilars

EMA to Launch Tailored Biosimilar Scientific Advice Pilot By Zachary Brennan - Published 16 December 2016

The European Medicines Agency (EMA) on Friday announced that it will launch a tailored scientific advice pilot project in February 2017 to support the development of new biosimilars.

Categories: News, Europe, EMA, Biologics and biotechnology, Due Diligence, Regulatory intelligence, Regulatory strategy

Tags: biosimilars, biosimilar scientific advice, biosimilar data

Bridging the Gap: Satisfying Payers in an Era of Expedited Regulatory Pathways  By Richard Macaulay, PhD - Published 16 December 2016

This article discusses the divergent evidentiary requirements of payers and regulators and the strategies companies can employ to help bridge this gap to ensure expedited regulatory approval effectively translates into reimbursement and patient access.

Categories: Features, Asia, Europe, US, EMA, FDA, NICE, Biologics and biotechnology, Drugs, Reimbursement

Japan Joins International API Manufacturing Inspection Program By Zachary Brennan - Published 15 December 2016

Japan’s Pharmaceutical and Medical Devices Agency (PMDA) announced Thursday that it will join with the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulators to improve the efficiency and effectiveness of good manufacturing practice (GMP) inspections for sites producing active pharmaceutical ingredients (APIs).

Categories: News, Asia, Europe, US, EMA, FDA, PMDA, Active pharmaceutical ingredients, Manufacturing

Tags: ICH Q7, API manufacturing inspections

Regulatory Recon: Two Former Pharma Execs Charged With Price Fixing; FDA Extends Comment Period for Off-Label Promo Comments (15 December 2016) By Zachary Brennan - Published 15 December 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

Categories: News, Asia, Canada, Europe, US, EMA, FDA, Health Canada, MHLW, WHO, Biologics and biotechnology, Drugs, Medical Devices

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

NICE Joins FDA Program to Shorten Time Between Device Approval and Insurer Coverage By Zachary Brennan - Published 15 December 2016

The UK’s National Institute for Health and Care Excellence (NICE) on Wednesday announced that it would participate in the US Food and Drug Administration’s (FDA) Payer Communication Task Force (PCTF) to help speed patients’ access to new medical devices, diagnostics and other health-related technologies.

Categories: News, Europe, US, CDRH, NICE, Due Diligence, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: NICE, medical device insurer coverage, medical devices and approval

Global Developments of Biosimilars By Randolph Fillmore - Published 15 December 2016

This article was developed from presentations at the 2016 RAPS Regulatory Convergence meeting held in San Jose. The session titled "Biosimilars," was led by Arpita Shah, PharmD, senior manager, regulatory intelligence and policy, Celgene Corporation. Speakers included  Leah Christl, associate director, therapeutic biologics, FDA, CDER, Sabine Haubenreisser, MSc, PhD, EMA liaison official at the FDA and Tara Sanderson, associate director, project manager, CMC regulatory affairs, ERA Consulting.

Categories: Features, Asia, Canada, Europe, US, EMA, FDA, Health Canada, PMDA, Biologics and biotechnology

Tags: Biosimilars