Search Results for

Filtering on: "geography europe"

Showing 1 – 25  of 754

European Commission: Cranberry Products Are Not Medical Devices By Zachary Brennan - Published 26 May 2017

The European Commission's regulatory committee on medical devices on 19 May voted in favor of the commission's decision that products "whose principal intended action, depending on proanthocyanidins (PAC) present in cranberry extract, is to prevent or treat cystitis," also known as bladder inflammation or infection, "are not medical devices within the meaning of Article 1 (2) (a) of the Medical Devices Directive."

Categories: News, Europe, EC, EMA, Medical Devices

Tags: cranberries, UTIs, bladder infections, medical devices and cranberries

FDA, EMA and PMDA Seek Antimicrobial Clinical Study Regulation Harmonization By Zachary Brennan - Published 26 May 2017

For the second time in seven months, the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) met in late April to discuss their approaches for evaluating antimicrobial agents, with the aim of identifying areas for convergence.

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

Tags: antimicrobial resistance, antibiotic resistance, new antibiotics

EMA Adds Five Therapies to PRIME Scheme, Bringing Total to 25 By Michael Mezher - Published 26 May 2017

The European Medicines Agency (EMA) on Wednesday announced that it has accepted five additional therapies to its PRIME (PRIority MEdicines) scheme, bringing the total number of products accepted to the program to 25.

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

Tags: PRIME, Priority Medicines

European Regulatory Roundup: Merck Accused of Blocking Remicade Biosimilars (25 May 2017) By Nick Paul Taylor - Published 25 May 2017

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

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

Tags: Remicade biosimilar, ENVI, whistleblowers

EMA Offers Draft Guideline on Serious Breaches of Clinical Trial Regulations By Zachary Brennan - Published 23 May 2017

The European Medicines Agency (EMA) on Tuesday opened for public consultation a new guideline on serious breaches of clinical trial regulations or clinical trial protocols.

Categories: News, Europe, EMA, Clinical, Compliance, Government affairs, Research and development

Tags: clinical trial regulations, EMA guideline

Regulatory Recon: FDA Approves New Rheumatoid Arthritis Treatment; Alexion C-Suite Overhaul (23 May 2017) By Zachary Brennan - Published 23 May 2017

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

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

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

Regulatory Recon: WHO Hosts 70th World Health Assembly; AstraZeneca Sells Rights to Heart Drug for $300M (22 May 2017) By Zachary Brennan - Published 22 May 2017

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

Categories: News, Asia, Canada, Europe, Latin America and Caribbean, US, FDA, MHLW, WHO, Biologics and biotechnology, Drugs, Medical Devices

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

EMA to Launch Revamped EudraVigilance System to Monitor Adverse Events By Zachary Brennan - Published 22 May 2017

The European Medicines Agency’s (EMA) management board on Monday endorsed the launch on 22 November 2017 of an improved system for collecting and monitoring suspected adverse events.

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

Tags: EudraVigilance, ICSR, adverse events, marketing authorisation holders

EMA’s CHMP Recommends Approval for Five New Medicines, Four New Biosimilars By Zachary Brennan - Published 19 May 2017

The European Medicines Agency (EMA) met earlier this week and signed off on five new medicines, including one new advanced therapy, as well as four biosimilars and one generic drug.

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

Tags: CHMP, Sanofi, Celltrion, XBiotech, Spherox

Regulatory Recon: FDA Expands Use of CF Drug; ASCO Abstracts Released (18 May 2017) By Zachary Brennan - Published 18 May 2017

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

Categories: Canada, Europe, US, FDA, Health Canada, Biologics and biotechnology, Drugs, Medical Devices

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

European Regulatory Roundup: Commission Begins Investigation Into Cancer Drug Prices (18 May 2017) By Nick Paul Taylor - Published 18 May 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: European Regulatory Roundup, EU roundup of pharma news, Aspen, personalized medicine, ANSM

RAPS and Industry Experts Join Forces for Dedicated MDR Workshop By RAPS Staff - Published 18 May 2017

RAPS is bringing together a panel of Europe’s top industry experts to deliver a dedicated workshop on the new EU regulations for medical devices and in vitro diagnostic devices.

Categories: HTML, Articles, Under RAPS, Europe, RAPS

Tags: EU, Medical Device Regulations, IVD Regulations

FDA Adds Boxed Warning to Janssen's Type 2 Diabetes Drug Label By Zachary Brennan - Published 16 May 2017

Based on new data from two large clinical trials, the US Food and Drug Administration (FDA) on Tuesday concluded that Janssen’s type 2 diabetes medicine canagliflozin (brand names include Invokana, Invokamet and Invokamet XR) causes an increased risk of leg and foot amputations.

Categories: News, Europe, US, EMA, FDA, MHRA, Clinical, Crisis management, Drugs, Postmarket surveillance

Tags: Janssen, SGLT2 inhibitors, FDA warning

ICH Q12 Post Approval Change Management Protocol: Advantages for Consumers, Regulators and Industry By Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Vijayalakshmi Iyer - Published 16 May 2017

This article discusses the latest draft of ICH Q12 and significance of harmonizing regulatory requirements across regional borders. It emphasizes how Post-Approval Change Management Protocol (PACMP) can be used as a tool to improve strategic change management and ensure supply chain reliability.

Categories: Features, Europe, US, FDA, ICH, Biologics and biotechnology, Drugs, Quality

Tags: ICH Q12, Post Approval Change Management Protocol, Quality by Design, QbD

EU Health Tech Assessments: Majority Favor Continuing Beyond 2020 By Zachary Brennan - Published 15 May 2017

A majority of respondents to a European Commission questionnaire says health technology assessment (HTA) cooperation at the EU level should continue beyond 2020.

Categories: News, Europe, EC, EMA, MHRA, NICE, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: HTA, health technology assessments, European Commission report

WHO Officials Offer Opposition to Value-Based Drug Pricing By Zachary Brennan - Published 12 May 2017

World Health Organization (WHO) officials told press in a briefing on Thursday that the agency has serious reservations with value-based pharmaceutical pricing systems.

Categories: News, Asia, Canada, Europe, US, NICE, WHO, Biologics and biotechnology, Drugs, Government affairs

Tags: WHO on drug pricing, fair pricing forum, pharmaceutical pricing

Regulatory Recon: French Regulators Halt ALS Trial; FDA Revisits Opioid Prescriber Training (12 May 2017) By Zachary Brennan - Published 12 May 2017

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

Categories: News, Canada, Europe, US, CFDA, EMA, FDA, MHRA, NICE, WHO, Biologics and biotechnology, Drugs, Medical Devices

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

European Regulatory Roundup: EMA Issues Increasing Number of GMP Non-Compliance Statements in India (11 May 2017) By Nick Paul Taylor - Published 11 May 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, Regulatory intelligence, Regulatory strategy

Tags: European regulatory roundup, PRAC, GMP inspections, flu vaccine guidance

10 Hot-Button Issues FDA’s New Commissioner Will Face By Zachary Brennan - Published 11 May 2017

Like his predecessors, Scott Gottlieb, the newly sworn-in commissioner of the US Food and Drug Administration (FDA), will have a full plate to tackle as he takes the reins of the short-staffed agency.

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

Tags: Scott Gottlieb, FDA commissioner, LDTs, Cures, opioids, off-label marketing, regulatory convergence

UK Patients to Get Early Access to AbbVie's HCV Combo By Michael Mezher - Published 10 May 2017

Patients in the UK will get early access to AbbVie's experimental pan-genotypic hepatitis C (HCV) drug combination, the Medicines and Healthcare products Regulatory Agency (MHRA) announced Wednesday.

Categories: News, Europe, MHRA, Drugs, Submission and registration

Tags: EAMS, Early Access to Medicines Scheme, Glecaprevir, Pibrentasvir, AbbVie

EMA Report on 2016: 27 New Drugs, New Priority Scheme, Trial Transparency By Zachary Brennan - Published 10 May 2017

With the European Medicines Agency’s (EMA) departure from London and loss of UK expertise (about 60 of the 897 EMA staffers are from the UK) looking more likely, the agency on Wednesday released a report outlining its successes from 2016, when 27 new medicines were authorized and several new programs took shape.

Categories: News, Europe, EC, EMA, Active pharmaceutical ingredients, Biologics and biotechnology, Clinical, Compliance, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: PRIME, Brexit, EMA in 2016

Biosimilars in the EU: New IMS Report Shows Savings Through Competition By Zachary Brennan - Published 09 May 2017

A new report released Tuesday, prepared by QuintilesIMS at the request of the European Commission, found EU countries are saving lots of money from biosimilars even if market share is low.

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

Tags: biosimilars, biologic competition, anti-TNF, HGH

Regulatory Harmonization Initiatives By Mukesh Kumar, RAC, Eliane Barras, MSc, Lewis Lau, RAC - Published 09 May 2017

This article provides an overview of global regulatory harmonization initiatives and addresses how various regulatory and other organizations are working toward improving access to medicinal products, such as pharmaceuticals and medical devices, and increasing quality through internationally harmonized inspection standards.

Categories: Features, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, Oceania, US, APEC, GHTF, ICH, IMDRF, ISO, OECD, WHO, Biologics and biotechnology, Compliance, Drugs, Medical Devices

Tags: Harmonization

EMA to Continue to Allow Patient Involvement in CHMP Meetings By Zachary Brennan - Published 08 May 2017

The European Medicines Agency (EMA) said Monday that it will continue to allow patients to offer viewpoints during the assessments of the benefits and risks of medicines before EMA’s Committee for Medicinal Products for Human Use (CHMP).

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

Tags: patient perspective, CHMP, benefits and risks of medicines

Final EU MDR, IVDR Texts Published, Countdown to Implementation Begins By Zachary Brennan - Published 05 May 2017

The final texts of the new European medical device and in vitro diagnostic (IVD) regulations were published on Friday in the Official Journal of the European Union, setting in motion the timeline for implementation of the new regulations, which is set to commence on 25 May.

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

Tags: EU MDR, IVDR, new medical device regulations, Europe regulations