Category Archives: Regulatory

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 The agency hopes to issue draft guidance by the end of the year that will outline a […]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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Ebola Crisis Could Spur Broader R&D Efforts

Up until a few months ago, there was little industry interest or public support for developing vaccines and treatments to combat the Ebola virus. Now the rush is on to launch clinical trials of therapies with some potential effectiveness against the disease. The situation has also encouraged FDA and regulatory authorities to facilitate these efforts […]
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European Pharma: Paying the Price of Pharmacovigilance

Pharmacovigilance controls are becoming firmly embedded in the European Union’s post-authorization regulatory system, with the European Medicines Agency (EMA) acting as the pivot for an EU-wide network of agencies monitoring medicines throughout their market lifespan. The new pharmacovigilance activities stemming from the EU legislation, the first stage of which was approved four years ago, relate […]
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Healthcare Reform in China: A Doubled-Edge Sword for Foreign Firms?

The Chinese market is attractive to foreign investors for many reasons. It is the world’s third largest market for pharmaceuticals with annual sale of US$71 billion.  In fact, it is poised to become the second largest market in 2015 given that its annual growth rate of sales is between 15 and 20%, according to Yanzhong […]
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