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23 May 2013
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EU regulators with the European Medicines Agency (EMA) have announced the issuance of six recommendations stemming from a workshop they recently conducted regarding methods to reduce medication
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23 May 2013
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The European Medicines Agency (EMA) has announced that its eSubmission Gateway will become mandatory for all electronic common technical document (eCTD) submissions made to the agency through the
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17 May 2013
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The European Medicines Agency (EMA) has announced its adoption of the International Conference on Harmonisation's (ICH) M7 guideline on controlling carcinogenic risk in pharmaceutical products when
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9 May 2013
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The European Medicines Agency (EMA) has announced that it will, starting immediately, be instituting new changes meant to simplify the process by which fees for orphan medicine applications are paid
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24 April 2013
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The European Medicines Agency (EMA) has announced the release of a new concept paper regarding the extrapolation of an experimental drug product's safety and efficacy data to other subgroups,
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9 April 2013
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A new "comprehensive analysis" conducted by the European Medicines Agency (EMA) has found that more than 60% of patients enrolled in pivotal trials submitted in support of drug applications—that is,
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4 April 2013
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EU regulators are preparing a new guideline to assist companies in the development of treatments for Autism Spectrum Disorder (ASD), a collective term referring to the wide range of disorders that
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Regulatory Update
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28 March 2013
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The European Medicines Agency (EMA) has announced a milestone safety review of drugs approved through both the centralized EU procedure and the national procedure, based on the active substance that a
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27 March 2013
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EU regulators have announced that they, like their US counterparts, are reassessing the risks associated with a class of diabetes drugs (GLP-1 incretin mimetics) in light of their potential to cause
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26 March 2013
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In its first meeting of 2013, the European Medicines Agency's (EMA) management board turned its sights on the agency's use of regulatory science, saying EU regulators need to adopt new approaches to
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