EMA asks companies with nationally authorized drugs to keep check on single assessments of PSURs
This article was originally published in SRA
Executive Summary
The European Medicines Agency has started publishing the outcomes of single assessments of periodic safety update reports (PSURs) for active substances that are only present in nationally-authorized medicines1,2. The EMA is advising companies with medicines authorized at the national level to monitor the published information regularly to check if it is of relevance to their products.