Category Archives: Regulatory

EFPIA Promises Stronger Ties with China

The European Federation of Pharmaceutical Industries and Associations (EFPIA) reports that it has “strengthened its commitment in China”. Federation delegates are this week concluding a visit to Beijing to establish “a better understanding of the numerous healthcare reforms underway in China … and explore closer paths of cooperation in global drug development between China and […]
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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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FDA Readies Quality Metrics Measures

 After almost two years of discussion and analysis, the Food and Drug Administration is finalizing a proposal for collecting data from manufacturers to help measure the performance of manufacturing operations and the quality of resulting drugs and biologics. The agency hopes to issue draft guidance by the end of the year that will outline a […]
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PPRS Payments Now Worth £150m in the UK

By Leela Barham. A second payment has now been made under the UK’s Pharmaceutical Price Regulation Scheme (PPRS). Adding a further £76m to the £74m for the first quarter of 2014, the payments received by the Department of Health (DH) now total £150m (US$244m).  Payments are a new feature of the long-standing voluntary PPRS. The […]
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