PSUR: periodic safety update report
A 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.
PSUR obligations sit in Articles 107b to 107g of Directive 2001/83/EC, with the format in GVP Module VII. Reports go to the EMA PSUR Repository, and substances on the EURD list get a single EU assessment (PSUSA) whose outcome can change the product information of every product containing the substance. Generics and well-established use products are usually exempt from routine PSURs unless the EURD list or the authorisation requires them.
Typical failures: missing a data lock point after the EURD list changes, and implementing PSUSA outcomes late.
Under the new pharma package (not yet in force), the default for MAs without a set frequency becomes yearly, three-yearly, then five-yearly, and EURD changes take effect after four months; see PSUR changes.
Timing
A PSUR is due within 70 days of the data lock point when it covers up to 12 months, and within 90 days when it covers a longer interval. Ad hoc requests set their own deadline.
Used in
Teams plan PSUR deadlines with renewals and variations in the lifecycle planning workflow.
Related terms
- Referral: EU-level assessment of a disputed or safety issueA referral is an EU procedure that resolves a scientific or regulatory issue about a medicine, or a class of medicines, in a single EU-level assessment.
- Type IB variation: minor change notified before implementationA Type IB variation is a minor change that is neither Type IA nor Type II and must be notified to the authority before it is implemented.
- 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.
- PSUSA: PSUR single assessmentA 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.
- 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.
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