Results 171 to 180 of about 73,173 (211)
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A future for regulatory science in the European Union: the European Medicines Agency’s strategy
Nature Reviews Drug Discovery, 2020After 3 years of co-design with stakeholders and EU regulatory partners, the European Medicines Agency's Regulatory Science to 2025 strategy has been finalized. Here, we highlight the core recommendations that stakeholders deem most significant to advance evidence generation.
Rosanne Janssens, Philip Hines
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Opening up data at the European Medicines Agency
BMJ, 2011Widespread selective reporting of research results means we don’t know the true benefits and harms of prescribed drugs. Peter Gotzsche and Anders Jorgensen describe their efforts to get access to unpublished trial reports from the European Medicines ...
Gøtzsche, Peter C, Jørgensen, Anders W
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Medicines for children licensed by the European Agency for the Evaluation of Medicinal Products
European Journal of Clinical Pharmacology, 2002. The aim of this study was to evaluate the number and the characteristics of medicines approved for children in Europe by the European Agency for the Evaluation of Medicinal Products (EMEA) and whether the paediatric studies supporting the authorisation were in accordance with the Note for Guidance on the Clinical Investigation of Medicinal Products ...
A, Ceci +8 more
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European Medicines Agency withdrawal for sibutramine
Archives of Disease in Childhood, 2010In January 2010, the European Medicines Agency withdrew its approval for sibutramine and the Food and Drug Administration has restricted its license based on concerns about a raised cardiovascular risk found in the Sibutramine Cardiovascular Outcome Trial (SCOUT) preliminary report.1 2 Despite being contraindicated in poorly controlled hypertension and
Galhardo, J +3 more
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The European Medicines Agency and Heads of Medicines Agencies
Abstract This chapter describes the role of the European Medicines Agency (EMA) as the EU agency tasked with coordinating the scientific resources of member state competent authorities and the evaluation of marketing authorization applications submitted via the centralized procedure.Phil Ambery +2 more
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JUPITER, rosuvastatin, and the European Medicines Agency
The Lancet, 2010As the principal investigator (PMR) and independent academic statistician (RJG) for the JUPITER trial, we note with interest that, on the basis of our trial data, the European Medicines Agency recently approved the use of rosuvastatin for the “prevention of major cardiovascular events in patients who are estimated to have a high risk for a fi rst ...
Paul M Ridker, Robert J Glynn
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The European Medicines Agency Experience with Biomarker Qualification
2014Since the launch of the qualification process in 2009, the CHMP reviewed/is reviewing 48 requests for qualification advice or opinion (as of Sept 2013) related to biomarkers (BM) or other novel drug development tools (e.g. patient reported outcome measures, modeling, and statistical methods). The qualification opinions are available on the EMA website (
Efthymios, Manolis +3 more
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The European Medicines Agency Discovers the Geriatric Patient
Drugs & Aging, 2011Polypharmacy in older persons is not new. A century ago, James Ensor painted his mother on her deathbed, with 20 bottles of medicines on her bedside table. However, polypharmacy is a growing problem because the life expectancy from birth is increasing (by 3 months on average every year in the more developed world), with people enjoying better health ...
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The European Agency for the Evaluation of Medicines and European Regulation of Pharmaceuticals
European Law Journal, 1996Abstract: The new European Agency for the Evaluation of Medicinal Products is the focus of the EC's new regulatory framework for approval of pharmaceuticals for human and veterinary use. This article considers past efforts at European pharmaceutical regulation, discusses the new ‘centralised’ and ‘decentralised’ procedures, and offers a functional ...
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