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  • EU Overhaul of Clinical Trials Directive Advances, Would Demand Full Data Transparency

    • 30 May 2013
    The European Parliament's (EP) Committee on the Environment, Public Health and Food Safety (ENVI) has endorsed and released a new draft rule regarding clinical trials for new medicines, saying the changes should result in "simpler, more uniform" rules and halt a five-year decline in clinical trials being conducted in the EU region. Background The rule was first called for in July 2012 by then-health commissioner John Dalli, who pointed to the 25% decline in EU clinical ...
  • Amended EU Clinical Trials Proposal Calls for Full Publication of Clinical Trials Data

    A newly-amended draft report published by the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) seeks to advance a proposal that would overhaul the EU's clinical trials regulatory framework by repealing Directive 2001/20/EC and replacing it with a new regulation.  [ Editor's note: a previous version said it would be replaced with a new Directive. It is instead being replaced with a new regulation. ] The 55-page draft include...
  • Industry Pans EU Plan to Implement Medical Device Registry

    One of the medical device industry's biggest organizations is sounding off against a plan by the European Parliament to implement postmarketing medical device implant registry system that aims to protect consumers against the types of problems currently plaguing the European market. As Regulatory Focus reported on 27 April, the European Parliament released the plans after two prominent medical device failures -metal-on-metal hip implants manufacturer by, among other...
  • EU Looks to Tighten Medical Device Safety With Implant Registry

    The European Parliament is actively looking to pass legislation that would make it easier for regulatory authorities to track both medical devices and patients implanted with medical devices, reports Fierce Medical Devices . "These proposals include the creation of breast implant registers, product traceability and a pre-market authorization system--among other items--to prevent future such episodes involving implantable devices," wrote Fierce . A Committee withi...
  • European Parliament Refuses to Approve EMA's 2010 Spending, 2013 Budget

    The European Parliament is refusing to approve of how the European Medicines Agency (EMA) spent its fiscal year 2010 budget-a move that is delaying the approval of EMA's fiscal year 2013 budget , reports PharmaTimes . "The Parliament's Budgetary Control Committee voted 14-9 this week in favor of postponing the EMA's budget management "discharge" (approval) procedure until the Agency presents it with an action plan to improve procurement and contract management," wrote ...