EMA to conduct PSURs of nationally authorised meds

Reactions 1446 - 6 Apr 2013

■ The EMA is to begin conducting periodic safetyupdate reports (PSURs) on active substances for allmedicines authorised in more than one Member State.Until now, the Agency has only been assessing PSURsfor centrally authorised medicines. From 1 April 2013,it will start carrying out single assessments of PSURsof active substances contained in centrally authorisedmedicines alone, as well as those found in medicinesauthorised both centrally and nationally. Activesubstances found only in nationally authorisedmedicines will also be subject to a centralisedassessment beyond 2013. The aim of conducting thesesingle assessments of PSURs is to harmonise andstrengthen the safety and benefit-risk review ofmedicines across the EU Member States.EMA. European Medicines Agency to begin PSUR assessment based on activesubstances in both centrally and nationally authorised medicines. InternetDocument : 27 Mar 2013. Available from: URL: http://www.ema.europa.eu 803085355

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Reactions 6 Apr 2013 No. 14460114-9954/10/1446-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved