Periodic safety update report single assessments (PSUSAs) provide a coordinated EU assessment of PSURs for medicines containing the same active substance or combination.
Official resource
- EMA PSUSA procedure repository — searchable PSUSA procedure pages and regulatory outcomes.
What to look for
A PSUSA page may contain the active substance in scope, procedure number, regulatory outcome, lists of nationally authorised products, scientific conclusions, required product-information amendments and an implementation timetable.
Practical use
Use the repository to determine whether a periodic benefit-risk evaluation resulted in regulatory action and to retrieve the exact wording and implementation expectations. For nationally authorised products, the published CMDh or Commission material may be especially important for local implementation.
The PSUSA outcome should be read together with the EURD list, the underlying PSUR procedural framework and relevant national implementation requirements.