Search Results for European Regulatory Roundup

Showing 1 – 25  of 93

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

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

European Regulatory Roundup: UK Fines Pfizer for 2,600% Price Hike (8 December 2016) By Nick Paul Taylor - Published 08 December 2016

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, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: European Regulatory Roundup, Pfizer, ATMP, GMP manufacturing, antimicrobial resistance

European Regulatory Roundup: EMA Releases Draft Guidance on Using Pictograms on Packaging (1 December 2016) By Nick Paul Taylor - Published 01 December 2016

The European Medicines Agency (EMA) has posted draft guidance on the use of approved pictograms on veterinary medicinal product packaging. EMA has drafted the document to create a harmonized set of pictograms marketing authorization holders (MAHs) can use to communicate effectively in the limited space available on product packaging.

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

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

European Regulatory Roundup: Sweden Lays Groundwork for Adoption of Adaptive Approval Pathway (3 November 2016) By Nick Paul Taylor - Published 03 November 2016

The Medical Products Agency (MPA) of Sweden has published a report ahead of an anticipated uptick in the use of the adaptive approval pathway in Alzheimer's disease and other indications. MPA wants to set up working groups to solve issues it identified with the application of the model to Alzheimer's, while also taking steps to involve patients more in the process.

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

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

European Regulatory Roundup: Brexit Czar Plans 'Standardized' Approval Processes After Leaving EU (13 October 2016) By Nick Paul Taylor - Published 13 October 2016

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

Categories: News, Europe, EMA, MHRA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Medical Devices, Submission and registration

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

European Regulatory Roundup: EMA to Discuss Future of Adaptive Pathways Program (15 September 2016) By Nick Paul Taylor - Published 15 September 2016

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

Categories: News, Europe, EC, EMA, MHRA, Clinical, Drugs, Government affairs, Manufacturing

Tags: European Regulatory Roundup, Brexit, adaptive pathways, Emer Cooke

European Regulatory Roundup: EU Council Presidency to Prioritize Drug Availability; Eisai, IQWiG Clash Over Halaven (8 September 2016) By Nick Paul Taylor - Published 08 September 2016

The Slovak presidency of the EU Council of Ministers has identified improvements to the availability of drugs as a top priority for its time at the head of the organization. Slovakia is setting the agenda at the Council until the end of the year, giving it several months in which to advance its ambitions.

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

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