PSURs are a regulatory requirement for authorised medicines in the EU and some other countries. They are generated by companies for each of their products at specified intervals – in the EU every 6 months for the first 2 years of marketing, then annually until the first renewal (at 4.5 years) and then every 3 years.
The PSUR provides an overview of the safety of the product, and includes all ADRs reported in the period since the last PSUR, together with a summary of the registration status of the product worldwide, actions taken for safety reasons, the worldwide usage of the product and an analysis of safety. The PSUR gives an opportunity for review of benefits and risks at intervals. Their preparation involves significant work by companies and the timing of their submission and content is subject to the regulations. Analogous documents are required for clinical trials –Annual Safety Reports covering every study on each investigational product.Tags:ADRs, analysis of safety, annual safety reports, authorised medicines, benefits and risks, clinical trials, PSUR, PSURs, regulatory requirement