EMA publication of safety reports for nationally authorised medicines will support timely and harmonised implementation of safety measures in EU Member States
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.
In the single assessment of nationally authorised products, a lead Member State is appointed to assess whether new risks have been identified or the balance of benefits and risks of a medicine has changed. The assessment is reviewed by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). Based on the results they decide if any action is needed to protect the public from any risks identified or if further investigations need to be carried out. The need for such action is confirmed by the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh). The single assessment of PSURs for medicines with the same active substance aims to harmonise and strengthen the monitoring of the benefits and risks of all authorised medicines across the EU and is a deliverable of the 2010 pharmacovigilance legislation. In addition, the Agency already publishes the outcomes of PSURs for centrally authorised medicines, which can be found together with the medicine’s European public assessment report.
To support Member States and pharmaceutical companies to implement the outcomes of the assessments, EMA is now publishing the results of these procedures together with the lists of medicines concerned.1 Furthermore, when the procedure leads to a variation of marketing authorisations, a whole set of information materials is published in all official EU languages: the scientific conclusions, a timetable for implementation of the variation, and where amendments to the product information are required, the wording of the product information.
When a PSUR single assessment procedure leads to a variation of the marketing authorisation, marketing-authorisation holders for products containing the active substance(s) concerned should submit a variation to the relevant national competent authority to align their marketing authorisation with the single assessment outcome (this includes generic medicines or medicines authorised on the basis of well-established use).2
1 Single assessments of PSURs for centrally authorised medicines began in July 2012 (outcomes published as part of the EPAR), and for both centrally and nationally-authorised medicines in April 2013 (outcomes published on the European Commission’s community register).
2 This is in line with Article 23 of Directive 2001/83/EC and Article 16 of regulation (EC) No 726/2004.