Posted by Michael Wonder on 06 Apr 2017
Optimising safety information for medicines in Europe throughout product lifecycle
6 April 2017 - New guidance and process improvement for periodic safety update reports
Following two years of experience with safety monitoring of nationally authorised medicines via the single assessment of periodic safety update reports (PSURs), the EMA has issued additional guidance and recommendations as part of its commitment to continuous process improvement.
PSURs are reports that evaluate the benefit-risk balance of a medicine as evidence is gathered in clinical use. 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 linked to a medicine or if the balance of benefits and risks of a medicine has changed. Based on this information, EMA decides whether further investigations are needed or whether measures have to be taken to protect public health, generally via updated product information for healthcare professionals and patients. If medicinal products contain the same active substance or the same combination of active substances, the related PSURs will be jointly assessed in a single assessment procedure.
