On 26 Jan 2015, the EMA launched a central electronic repository to facilitate assessment of medicines safety reports. This repository has been created in accordance with the pharmacovigilance legislation of the EU and will contain all information related to Periodic Safety Update Reports (PSUR) in the EU and will allow assessment of PSURs by medicines regulatory authorities in the EU.
Pharmaceutical companies are required to submit PSURs to the EMA on a periodic basis. The PSUR summarises the results of an evaluation by the pharmaceutical company of the benefits and risks of the authorised medicine. The EMA then uses this information to determine if new risks are identified or if the risk-benefit balance of a medicine has changed and to take appropriate action. The central repository stores PSURs, PSUR assessment reports, comments, and final outcomes, and gives secure access to authorised users from national competent authorities in EU Member States, the EMA, Agency committees, and the European Commission. It ensures that all those involved in benefit-risk assessments of medicines have timely access to all relevant documents in one location.
Webinars on the PSUR repository for the pharmaceutical industry will be organised in Feb 2015 followed by weekly question and answer sessions.