PSUSA: PSUR single assessment
A PSUSA is the single EU assessment of all periodic safety update reports for one active substance, led by the PRAC and binding on every holder.
The PSUR single assessment is set out in Articles 107e to 107g of Directive 2001/83/EC and Article 28 of Regulation (EC) No 726/2004. Where a substance is on the EURD list, every holder of a product containing it submits a PSUR for the same data lock point, and one PRAC rapporteur assesses them together. The procedure applies to centrally authorised products, to nationally authorised products, and to substances with both, and it was introduced by the 2012 pharmacovigilance legislation to replace separate national assessments of the same data.
The PRAC adopts an assessment report and a recommendation. Where at least one centrally authorised product is involved, the CHMP adopts an opinion and the Commission decides; where only nationally authorised products are involved, the CMDh adopts a position, implemented directly by Member States if agreed by consensus or decided by the Commission if agreed by majority. The outcome can be no change, a variation of the product information for every product containing the substance, a new condition of the authorisation, or in rare cases suspension or revocation. Holders file the resulting variations themselves within the deadline the outcome sets.
Reports are submitted through the PSUR Repository in the EU format of GVP Module VII, and the Repository is the only route; national submissions are not accepted. Generics and other products exempt from routine PSURs are still bound by the outcome, and their holders must implement the same product information changes even though they submitted nothing.
What goes wrong: a report that omits products or data the rapporteur expects, which shows in the published assessment; responses to the request for supplementary information that miss the timetable; and holders who do not notice the outcome because they were not part of the procedure, then find their product information out of line at the next variation or inspection. Translating the outcome into every national text within the deadline is the main operational burden.
Under the new pharma package (not yet in force), the single assessment continues under the new Regulation, with the default PSUR cycle changed for authorisations that have no set frequency; see PSUR changes.
Timing
The procedure starts on the published start date after the submission deadline for the data lock point. The PRAC rapporteur circulates a preliminary assessment report around Day 60, other members and holders comment, and the PRAC adopts its recommendation at a plenary around Day 120 where no further information is needed. A request for supplementary information adds a clock-stop and a further assessment round. The CHMP opinion or CMDh position follows at the next meeting, and holders then submit the implementing variations within the deadline set in the outcome.
Used in
Regulatory and pharmacovigilance teams catch PSUSA outcomes for your substances when they are published with Alerts.
Related terms
- PSUR: periodic safety update reportA periodic safety update report (PSUR) is a holder's periodic benefit-risk evaluation of a medicine, due at intervals set by the EURD list or the MA.
- EURD list: list of Union reference dates and PSUR frequenciesThe EURD list sets the Union reference date, data lock points and PSUR submission frequency for each active substance authorised in the EU.
- PRAC: Pharmacovigilance Risk Assessment CommitteeThe PRAC is the EMA committee that assesses the safety of human medicines in the EU, from risk management plans and PSURs to signals and safety referrals.
- CMDh: Co-ordination Group for Mutual Recognition and Decentralised ProceduresThe CMDh is the group of national authority representatives that resolves disagreements in MRP and DCP and coordinates nationally authorised medicines.
- Worksharing: one assessment of a variation across several authorisationsWorksharing lets one authority assess the same Type IB or Type II variation for several marketing authorisations of the same holder in a single procedure.
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