EMA to begin PSUR assessment based on active substances in both centrally and nationally authorised medicines
On 1 April 2013, the European Medicines Agency will start carrying out single assessments of periodic safety update reports (PSURs) of active substances contained in both centrally and nationally authorised medicines. The new single assessment means that the Agency will analyse all of the reports for medicines containing a particular active substance, for all types of marketing authorisation and for medicines authorised in more than one Member State. Until now, the Agency has only been assessing PSURs for centrally authorised medicines.
During 2013, the single assessment will cover active substances contained in centrally authorised medicines and active substances found in both centrally and nationally authorised medicines. Active substances only found in nationally authorised medicines will not be subject to a centralised assessment by the Agency until after 2013.
The single assessment of PSURs is a deliverable of the 2010 pharmacovigilance legislation. It aims to harmonise and strengthen the safety and benefit-risk review of medicines across the European Economic Area. To assist with this harmonised assessment, in October 2012 the Agency published a list of EU reference dates and frequency of submission of PSURs for active substances contained in medicines in the EU, known as the ‘EURD list’. Marketing-authorisation holders are required to submit PSURs to national competent authorities and the Agency according to the dates published in this list.
PSURs are reports providing an evaluation of the benefit-risk balance of a medicine. They are submitted by marketing-authorisation holders at defined time points following a medicine’s authorisation. The Agency uses the information in PSURs to determine if there are new risks identified for a medicine or whether the balance of benefits and risks of a medicine has changed, to decide if further investigations need to be carried out or to take action to protect the public from the risks identified such as updating the information provided for healthcare professionals and patients.
Active substances contained only in nationally authorised medicines will not be subject to single assessment during 2013. For this reason, the latest version of the EURD list only contains active substances included in centrally authorised medicines and those in nationally authorised medicines with a data lock point after 31 August 2014. Active substances found only in nationally authorised medicines with a data lock point before this date are available on PSUR work sharing and synchronisation project.
Posted on the EMA website on 27 March 2013