The European Medicines Agency (EMA) has started to publish the outcomes of single assessments of periodic safety update reports (PSURs) for active substances contained only in nationally authorised medicines. This initiative aims to support the harmonised implementation of safety measures for medicines with the same active substance across European Union (EU) Member States.

All pharmaceutical companies holding marketing authorisations for medicines at national level are advised to regularly monitor the published information to check for outcomes relevant to their products.

PSURs are reports providing a regular evaluation of the benefit-risk balance of a medicine following authorisation, which marketing-authorisation holders submit at regular intervals to the competent medicines regulatory authority in the EU as long as a medicine is available on the market. A single assessment of related PSURs is carried out for medicines that contain the same active substance or combination of active substances.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/07/news_detail_002361.jsp&mid=WC0b01ac058004d5c1