EMA Launches Drug Safety Assessment Platform

The European Medicines Agency (EMA) announced on Jan. 26, 2015 the creation of an electronic repository for periodic safety update reports (PSURs) and their assessment reports. The central platform, created in accordance with the pharmacovigilance legislation of the European Union (EU), will contain all information related to PSURs in the EU. According to EMA, “it will facilitate the assessment of PSURs by medicines regulatory authorities in the EU.”

The new repository will story PSURs, PSUR assessment reports, comments, and final outcomes. Authorized users from national competent authorities in EU Member States as well as the EMA, agency committees, and the European Commission will have secure, timely access to the repository. According to EMA,  “the repository also facilitates the electronic submission of PSURs by pharmaceutical industry. While PSURS are transmitted via the existing eSubmission Gateway/Web Client, which are the Agency’s secure electronic submission channels for documents supporting applications for human medicines, companies can now complete an XML delivery file attached to the submission and no longer need to use manual file naming conventions.”

EMA uses benefit and risk information provided by pharmaceutical companies in PSURs to “determine whether new risks are identified for a medicine or the balance of benefits and risks of a medicine has changed and take appropriate action.” PSURs of drugs containing the same active substances, or combinations of active substances, are assessed together even if the specific substances are contained in different medicines and authorized in more than one Member State.

Source: European Medicines Agency