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The Agency published the final reflection paper on ethical and good clinical practice (GCP) aspects of clinical trials of medicinal products for human use conducted outside of the European Union (EU)/European Economic Area (EEA) and submitted in marketing authorisation applications to the EU regulatory authorities. Entering into force on 1 May 2012, the aim of the paper is to strengthen existing processes to provide assurance to regulators and stakeholders that clinical trials meet the required ethical and GCP standards, no matter where in the world they have been conducted.
EMA - European Medicines Agency - Mar, 24 Aprile 2012
http://www.ema.europa.eu
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The European Medicines Agency has recommended the suspension of all marketing authorisations for meprobamate-containing medicines for oral use in the European Union, because their risks, particularly the risk of serious side effects affecting the nervous system, are greater than their benefits.
EMA - European Medicines Agency - Mar, 24 Gennaio 2012
http://www.ema.europa.eu
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There are substantial research data available to support premenstrual dysphoric disorder (PMDD) as a diagnostic entity of a severe form of premenstrual disorder, which causes clinically relevant functional impairment and requires treatment. The European Medicines Agency document should be conceived as general guidance, and should be read in conjunction with other applicable EU and ICH guidelines.
EMA - European Medicines Agency - Mar, 6 Settembre 2011
http://www.ema.europa.eu
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As IVR/IWR systems are developed to facilitate overall drug management and expanded to assist with dose titration, unblinding and expiry date update, the intent of the paper is to provide guidance to the sponsors and to the IVR/IWR providers in the use of the systems within clinical trials and detail the expectations of the National Competent Authorities on such systems.
EMA - European Medicines Agency - Mar, 6 Settembre 2011
http://www.ema.europa.eu
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The aim of this paper is to describe the concept of risk based quality management in the setting of clinical research. Several related approaches have been described that focus on particular aspects of the research. The purpose of this reflection paper is to facilitate the development of a more systematic, prioritised, risk-based approach to quality management of clinical trials, to support the principles of Good Clinical Practice and to complement existing quality practices, requirements and standards.
EMA - European Medicines Agency - Mar, 6 Settembre 2011
http://www.ema.europa.eu
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The increase in applications of new products in the treatment of multiple sclerosis and numerous scientific advices given concerning multiple sclerosis indicates that the treatment of multiple sclerosis is a moving and changing field. In addition the current treatment options have changed the multiple sclerosis population.
EMA - European Medicines Agency - Lun, 11 Luglio 2011
http://www.ema.europa.eu
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Neuromuscular diseases encompass a broad spectrum of diverse muscular disorders (e.g. inherited myopathies, metabolic and inflammatory myopathies), diseases of neuromuscular transmission (e.g. myasthenia gravis, Lambert-Eaton myasthenic syndrome, hereditary neuromuscular disorders) as well as disorders of the upper and lower motoneurons (e.g. amyotrophic lateral sclerosis, spinal muscular atrophy). Neuromuscular diseases can involve both, muscles that are moved voluntarily and those that function automatically, e.g. for breathing.
EMA - European Medicines Agency - Lun, 11 Luglio 2011
http://www.ema.europa.eu
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In January 2007 Regulation EC No 1901/2006 (the “Paediatric Regulation”) entered into force. As a result of this Regulation, the number of paediatric formulations that the pharmaceutical industry will have to develop to support their clinical trials will increase.
EMA - European Medicines Agency - Lun, 27 Giugno 2011
http://www.ema.europa.eu