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EMA’s CHMP Adopts Updated Guideline on Manufacture of Finished Dosage Form By Zachary Brennan - Published 14 August 2017

The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) on Monday adopted an updated guideline on what manufacturing process information should be included in the marketing authorization application (MAA).

Categories: News, Europe, EC, EMA, Drugs, Manufacturing, Regulatory intelligence

Tags: CHMP, finished dosage form, pharmaceutical manufacturing

German Regulators Slam Dr. Reddy's Plant for Critical, Major Deficiencies By Zachary Brennan - Published 10 August 2017

Regulators working for the Central Authority for Supervision of Medicinal Products in Bavaria have published a statement of non-compliance with good manufacturing practices (GMP) following an August inspection of a Hyderabad, India-based manufacturing site run by Dr. Reddy's Laboratories.

Categories: News, Asia, Europe, EC, FDA, Drugs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: Dr. Reddy's, competent authorities, EudraGMDP

European Regulatory Roundup: EMA Revises Pharmacovigilance Guideline After Danish Agency Spots 'Big Problem' (10 August 2017) By Nick Paul Taylor - Published 10 August 2017

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

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

Tags: pharmacovigilance, DKMA, Swissmedic

European Regulatory Roundup: EMA Starts Consultation on Developing Drugs to Meet Needs of Older People (3 August 2017) By Nick Paul Taylor - Published 03 August 2017

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

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

Tags: European regulatory roundup, drugs for older people, radiopharmaceuticals

19 European Cities Vie to Host EMA Headquarters By Zachary Brennan - Published 01 August 2017

The European Commission on Tuesday said it will assess the 19 offers from EU cities to host the European Medicines Agency's (EMA) headquarters as it moves from London's Canary Wharf following Britain's decision to leave the EU.

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

Tags: EMA relocation, EMA headquarters, applications for new EMA headquarters

European Regulatory Roundup: New Pressure to Reverse Brexit Regulatory Split (13 July 2017) By Nick Paul Taylor - Published 13 July 2017

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

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

Tags: European Regulatory Roundup, Brexit, reimbursement

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

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

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

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

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

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,

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

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

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

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

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

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

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

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