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Regulatory Recon: Novo Diabetes Drug Succeeds in Key Trial; Generic Drugmakers Feel Pinch as Prices Crumble (17 August 2017) By Zachary Brennan - Published 17 August 2017

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

Categories: News, Asia, 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

New Research Compares Drug Regulators Around the Globe By Zachary Brennan - Published 11 August 2017

Pharmaceutical regulations vary widely in different countries, though new research published Friday in Nature Reviews Drug Discovery offers comparisons in terms of various regulators’ budgets, staff, new drug approvals and timelines for approvals.

Categories: News, Asia, Canada, Europe, US, Anvisa, CFDA, EMA, FDA, MHRA, PMDA, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: comparison of drug regulators, new drug approval times, drug regulator reviewers

FDA Commissioner Scott Gottlieb’s Keynote Among Highly Anticipated Sessions at RAPS Regulatory Convergence By Zachary Brousseau - Published 10 August 2017

RAPS will host its annual Regulatory Convergence conference at the Gaylord National Resort and Convention Center at National Harbor on the DC waterfront 9–12 September. This year’s event features more than 75 educational sessions and over 200 speakers, including an opening keynote from FDA Commissioner Scott Gottlieb.

Categories: HTML, Articles, Under RAPS, Anvisa, EMA, FDA, MHRA, PMDA, WHO, RAPS

European Regulatory Roundup: EMA Adopts Revised First-in-Human Trial Guidance; UK Appoints Industry Veteran Ahead of Negotiations with Pharma (27 July 2017) By Nick Paul Taylor - Published 27 July 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, Blood, Clinical, Drugs, Veterinary products

Tags: EU Regulatory Roundup, Regulatory Roundup

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: FDA Panel to Focus on Safety of CAR-T Therapy (10 July 2017) By Zachary Brennan - Published 10 July 2017

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

Categories: News, Europe, US, FDA, MHRA, NICE, WHO, Biologics and biotechnology, Drugs, 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

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

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

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

MHRA Updates Alert on Metal-on-Metal Hip Implants By Michael Mezher - Published 29 June 2017

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday issued an alert to healthcare professionals with updated recommendations for long-term follow-up for patients with metal-on-metal hip replacements.

Categories: News, Europe, MHRA, Medical Devices

Tags: Metal-on-Metal, Hip Replacement, Revision

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

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

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

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

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

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

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

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 to Pharma Companies: Prepare for UK to EU Shift By Zachary Brennan - Published 02 May 2017

Setting the stage for a likely exodus from the UK for pharmaceutical manufacturers and staff, the European Medicines Agency (EMA) on Tuesday notified marketing authorization holders (MAHs) that for centrally authorized products, EU law requires them to be established in the EU or European Economic Area, which includes Iceland, Liechtenstein and Norway.

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

Tags: Brexit, pharmaceutical companies in UK, MAHs in UK

UK Pharmacovigilance Post-Brexit: Lots of Questions, Few Answers By Zachary Brennan - Published 01 May 2017

No one knows what UK pharmacovigilance will look like after the UK leaves the EU, and that uncertainty puts the many Qualified Persons Responsible for Pharmacovigilance (QPPV) residing in the UK in a precarious position.

Categories: News, Europe, EC, EMA, MHRA, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: Brexit, pharmacovigilance, Ian Hudson

EMA Plots Workload Shift Ahead of UK Experts' Departures in 2019 By Zachary Brennan - Published 28 April 2017

With a meeting yesterday between the European Medicines Agency's (EMA) Management Board and heads of the National Competent Authorities (NCAs) of the EU/EEA member states, a discussion was initiated on how to share the work of evaluating and monitoring medicines without the UK's help.

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

Tags: Brexit, EMA headquarters, EMA move

MHRA Plans for the Future of Drug, Device Regulation Post-Brexit By Zachary Brennan - Published 21 April 2017

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday released a business plan for the upcoming year, noting its primary focus on developing a consensus around a proposed model for the future of the country’s regulation of medicines and medical devices following its departure from the EU.

Categories: News, Europe, EC, EMA, MHRA, NICE, Drugs, Government affairs, Medical Devices

Tags: UK MHRA business plan, UK medical devices, pharmaceutical regulations

European Regulatory Roundup: EMA and FDA Discuss Joint Accelerated Assessments (20 April 2017) By Nick Paul Taylor - Published 20 April 2017

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

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

Tags: European Regulatory Roundup, EMA and FDA, EudraVigilance, information security