Search Results for European Regulatory Roundup

Showing 1 – 25  of 100

European Regulatory Roundup: EMA’s Rent Bill at €448M (30 November 2017) By Nick Paul Taylor - Published 30 November 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, Amsterdam EMA, Brexit

European Regulatory Roundup: EFPIA Warns of Insufficient Time to Move Marketing Authorizations Before Brexit (17 November 2017) By Nick Paul Taylor - Published 17 November 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, EU Regulatory Roundup

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

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

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

European Regulatory Roundup: EU Committee Slams Plan to Cut EMA Staffing Ahead of Brexit (7 September 2017) By Nick Paul Taylor - Published 07 September 2017

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

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

Tags: European Regulatory Roundup, Brexit, EMA staff cuts

European Regulatory Roundup: UK Calls for Brexit to Have Little Impact on Regulation (24 August 2017) By Nick Paul Taylor - Published 24 August 2017

The United Kingdom government has released a paper setting out its position on issues that will affect the availability of goods after Brexit. UK politicians want many regulatory factors relevant to drugmakers to remain the same immediately after Brexit, but to achieve this goal they will need persuade European negotiators to revise their position.

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

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

European Regulatory Roundup: Ireland Starts Consultation on Biosimilar Policy (17 August 2017) By Nick Paul Taylor - Published 17 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, Drugs

Tags: European regulatory roundup, Ireland biosimilars, CROs

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

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

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

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

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 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

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

European Regulatory Roundup: Dutch MEB Raises Concerns About use of ADHD Drug Ritalin in Adults (27 April 2017) By Nick Paul Taylor - Published 27 April 2017

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

Categories: News, Europe, EMA, Drugs, Veterinary products

Tags: European Regulatory Roundup, CVMP, MEB

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

European Regulatory Roundup: EMA Reports Year-Long Shortage of BMS Kidney Transplant Drug; UK Rejects Indication-Specific Drug Pricing (23 March 2017) By Nick Paul Taylor - Published 23 March 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, Reimbursement, Veterinary products

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

European Regulatory Roundup: EMA Recommends Approval of First Monoclonal Antibody Veterinary Medicine (23 February 2017) By Nick Paul Taylor - Published 23 February 2017

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

Categories: News, EMA, MHRA, Advertising and Promotion, Biologics and biotechnology, Drugs, Veterinary products

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

European Regulatory Roundup: House of Lords Backs Change to Drug Pricing Bill to Appease Pharma Industry (16 February 2017) By Nick Paul Taylor - Published 16 February 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, Business and Leadership, Government affairs

Tags: European regulatory roundup, biosimilars, Brexit

European Regulatory Roundup: ENVI Calls to for EMA Budget Reserves in Case of Brexit Volatility (9 February 2017) By Nick Paul Taylor - Published 09 February 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, Brexit, ENVI, aripiprazole, Hospira

European Regulatory Roundup: UK to Seek ‘Closest Possible Regulatory Equivalence’ With EMA Post-Brexit (26 January 2017) By Nick Paul Taylor - Published 26 January 2017

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, Business and Leadership, Drugs, Government affairs, Medical Devices

Tags: European Regulatory Roundup, Brexit, Theresa May, NICE Chair

European Regulatory Roundup: The Netherlands Bids to Host EMA (20 January 2017) By Nick Paul Taylor - Published 20 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: European Regulatory Roundup, Brexit

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