Category Archives: Europe

Market Access in Ukraine

by Lana Sinichkina  and Leonid Cherniavskyi. On September 16, 2014, the Ukrainian and European parliaments ratified the EU–Ukraine Association Agreement (AA), providing for harmonization of many spheres of Ukrainian legislation with EU policy. In line with the signed AA, the government has adopted a detailed implementation plan, which endorses for preparation and approval by the […]
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US Company Awarded UK's First "Promising Innovative Medicine" Designation

By Leela Barham. The UK’s Medicines and Healthcare Regulatory Authority (MHRA) has awarded Northwest Biotherapeutics, Inc. (Bethesda, MD) the very first “Promising Innovative Medicine”, or PIM designation, for the company’s DCVax-L product.
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Europe and Canada Welcome Trade Agreement Text

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and Canada’s Research-Based Pharmaceutical Companies (Rx&D) have welcome finalization of the text for the Comprehensive Economic and Trade Agreement (CETA). CETA represents the first free trade agreement between any G8 country. EFPIA and Rx&D believe it will, once in place, be beneficial to patients on both […]
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UK Postpones Decision on Value-Based Assessment — Again

By Leela Barham. Value-based Pricing (VBP) was first discussed as far back as 2007 by the UK’s consumer authority, the now defunct Office of Fair Trading (OFT).  The general concept of VBP was to set almost provisional prices based on the expected value of new medicines using immature data, with provisions to ‘correct’ the price […]
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EMA Calls Out to Companies Developing Ebola Treatments

The European Medicines Agency (EMA) is reviewing available information on Ebola treatments currently under development to “facilitate evidence-based decision-making” by health authorities. At the moment there are no approved medicines to protect from or treat Ebola. Some experimental treatments have reportedly shown encouraging results in the laboratory or in animals, but they have not yet […]
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