Tag Archives: European Union

The Year of Living Openly: Europe and Transparency 2015

The past year has brought significant changes not only in regulatory mandates and guidances but also regarding a broader overall emphasis on coordination of information and processes. The regulators have prioritized transparency and harmonization for some time but underscored them to an even greater degree in 2014; 2015 is likely to see the trend intensify.
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So Who’s in Charge of Medicines in Brussels?

So now we know who is to do what on health issues in the new European Commission. Or do we? The furor that the new boss of the commission, Jean-Claude Juncker, unleashed with the plans for his new team, weeks before it took office, is still reverberating around Brussels. Peter O’ Donnell reports on the […]
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What's the Future of European Health Policy?

What can be gleaned about the direction that health policy will take for the next five years under the new European Commission, scheduled to take office at the beginning of November? Peter O’ Donnell address this question in his new Applied Clinical Trials column here.
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Global Gaps in Standards Threaten Biosimilar Development

Although biopharmaceutical companies and regulatory authorities have made considerable progress in establishing policies for bringing biosimilars to market, key differences and gaps in requirements for testing and documenting product similarity still characterize the European Union, the U.S. and other regions. The EU’s European Medicines Agency (EMA) has set the regulatory pace, with 18 products approved since 2006, […]
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Biosimilar Development in Europe: Ten Years On

The European Union established the first legal regulatory guidelines for biosimilars in 2005. The first biosimilar, Omnitrope, a version of somatropin, was approved in April 2006. To date, the EU has approved 19 applications in total (two were withdrawn after authorization so 17 are now marketed) and continues to update its guidelines, general and product-specific, […]
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