Medical Literature Monitoring by the EMA
On May 12, 2015, the European Medicines Agency (EMA) announced that - in accordance with Article 27 of Regulation (EC) No. 726/2004 - starting on July 1, 2015, the search for suspected ADRs published in the scientific literature will be conducted by the EMA in selected literature sources and for certain active ingredients or combinations of active ingredients ("Medical Literature Monitoring (MLM)" service). The selection of active substances is based on the XEVMPD database (eXtended Eudravigilance Medicinal Product Dictionary) and includes, in particular, active substances with a high number of marketing authorizations. Details on the procedures, selection criteria, search strategies and the databases used, as well as the current list of active substances covered by the EMA, can be found on the EMA homepage at the following link: EMA - Literature MonitoringInaddition to searching for suspected ADRs (serious and non-serious) from the scientific literature, the MLM service also includes providing the result of these searches in the form of "Individual Case Safety Reports" (ICSRs), both to pharmaceutical companies and to national regulatory authorities. In this context, the EMA requests the marketing authorization holders to refrain from a repeated reporting of the cases already detected within the scope of the MLM service, thus the regulation according to § 75j. (4) of the German Medicines Act comes into force. The transmission of reports of substances that are not on the above-mentioned list will continue to be made to the Federal Office for Safety in Health Care until the full functionality (Article 24 (2) of Regulation (EC) No. 726/2004) of the Eudravigilance Database comes into force.
Further information:
UptoDate newsletter: Drug monitoring through the EMA's literature search for 400 substance groups
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Enquiries (technical):Mag. Katharina WeberTel.: +43 (0)50 555-36252Email: pharm-vigilanz@ages.at
