Tag Archives: European Medicines Agency

The European Regulatory Outlook for 2014

Pharm Exec’s EU correspondent, Reflector, looks at some of the European regulatory developments earmarked for 2014 and anticipates their effect on the industry. Personnel Some of the big influences on the pharma industry in Europe next year — and for several years to come — will be the big changes upcoming in key personnel in […]
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EMA Sets Budget and Priorities for 2014, Promotes Transparency

In a bid to improve transparency in 2014, the European Medical Agency’s December Management Board Meeting cleared the way for the publication of the agendas and minutes of the Agency’s Committee for Medicinal Products for Human Use (CHMP), Committee for Medicinal Products for Veterinary Use (CVMP) and Committee for Advanced Therapies (CAT). This week the EMA […]
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Unlikely European Allies Target Superbugs

The annual worldwide antibiotic awareness event—celebrated in Europe on November 15—generated some alarming statistics, some reassuring statements from official sources, and some expressions of urgency from drug developers. But it was perhaps most compellingly marked by a plangent call for better medicines from an unusual source. First, the statistics. Superbugs are on the way to […]
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Clinical Trial Data Disclosure in Europe: EMA Biting Off More than It Can Chew?

Is the EMA biting off more than it can chew? Reflector The European Medicines Agency’s ambitions are huge – as befits a body with such huge responsibilities. But its capacities to achieve what it sets out to do are now falling ever shorter. The latest deficiency is revealed by its admission that it cannot meet […]
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Who Dares to Stop the European Transparency Bandwagon?

Who is Trying to Stop the European Transparency Bandwagon? Reflector, EPE, October 14 2013 The data-transparency bandwagon is rolling rapidly across Europe, energetically propelled by regulators, health campaigners, and generic manufacturers. Much of the research-based industry is stepping out of the way of what looks like an unstoppable juggernaut, hoping at best to nudge it […]
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