PSUR reports and PBRERs in EU medicine safety assessments
A PSUR reviews a medicine's benefit-risk balance after authorisation. Learn how EU reporting dates, PBRERs and PSUSA assessments fit together in practice.
PSUR means periodic safety update report, a post-authorisation evaluation of a human medicine's benefit-risk balance. The marketing authorisation holder assesses new or emerging safety information alongside cumulative benefit and risk information. EMA's guidance sets out that purpose.
This guide covers EU human-medicines pharmacovigilance. For UK and US readers, it explains the terminology and EU deadlines, not local filing requirements. Medical-device PSURs are outside its scope.
What is a PSUR for?
The report asks whether the medicine's benefit-risk balance has changed at a defined point after authorisation. New safety information needs to be assessed in the context of what is already known about the medicine. A count of adverse events cannot answer that question on its own. EMA describes this purpose as a critical analysis of new or emerging information.
Normally, one report covers all the holder's products containing the same active substance. That scope includes authorised indications, routes of administration, dosage forms and regimens. A different strength does not, by itself, mean a separate PSUR is needed. Check the report's intended scope before treating each presentation as a separate reporting task. EMA's guidance sets out this usual approach.
Why PSUR and PBRER both appear
PBRER means periodic benefit-risk evaluation report. EU PSUR format and content follow the ICH E2C(R2) PBRER framework, while EU legislation retains the term PSUR. For this EU obligation, holders do not routinely submit separate PSUR and PBRER reports. See EMA's explanation of the relationship.
For an EU submission, use the PSUR requirements to establish the obligation and schedule. Use the PBRER framework to understand the report's format and content. Do not infer a second filing requirement simply because both acronyms appear in the same set of instructions.
What a periodic safety update report contains
EMA identifies the following high-level content:
- Summary information.
- A scientific assessment of new or emerging safety information.
- Cumulative information on benefits and risks that gives the assessment context.
- An integrated benefit-risk evaluation.
These categories explain the report's purpose. They are not a complete mandatory section checklist or a submission-ready template. The assessment must connect the new information to the medicine's benefit-risk balance, rather than leave the reader with an unassessed collection of safety findings.
Individual case listings and narratives are not routinely required. However, narratives must be included when they are integral to the analysis of a signal or safety concern. The EMA overview explains the exception.
When do companies submit PSURs in the EU?
The legal obligation falls on the marketing authorisation holder. Article 107b of Directive 2001/83/EC provides for electronic submission to EMA. EU PSURs for both centrally and nationally authorised medicines go through the central PSUR repository, according to EMA's submission guidance.
Start by checking whether the Union reference dates list, usually called the EURD list, covers the product. It is legally binding. Its reporting frequency overrides the standard submission cycle and marketing-authorisation conditions concerning frequency. Authorities can also request a report at any time. Do not calculate the next filing from the approval date alone. EMA explains the EURD list's role and links to the list.
Reporting interval, data lock point and deadline
Keep these dates separate. The reporting interval is the period the report covers. The data lock point is the reporting cut-off. The submission deadline is the date by which the report must be filed. EMA counts the data lock point as day 0 for the following submission windows. The applicable windows are:
| Reporting interval | Submission deadline after the data lock point |
|---|---|
| Up to and including 12 months | Within 70 calendar days |
| More than 12 months | Within 90 calendar days |
For an ad hoc report, follow the requested deadline, or submit within 90 days if none is specified. The submission deadline listed in the EURD list is legally binding. These windows are time to prepare and submit the report, not reporting frequencies or assessment durations. EMA gives these qualifications alongside the timetable.
Does every authorised medicine need routine PSURs?
No. Article 107b exempts certain categories from routine submission, subject to authorisation conditions or a competent-authority request. These include generics authorised under Article 10(1) and well-established-use products under Article 10a. They also include homeopathic registrations under Article 14 and traditional herbal registrations under Article 16a. Check the precise legal category in Directive 2001/83/EC.
Do not treat the word “generic” as a complete exemption check. EMA also identifies requirements through the EURD list. Review that list together with the authorisation conditions and any authority request before deciding that no report is due.
PSUSA means the assessment, not another report
A PSUSA is a PSUR single assessment. Harmonised reporting allows a single regulatory assessment for medicines containing the same active substance or combination. The company prepares the PSUR. PSUSA names the assessment procedure, not an extra reporting template. EMA describes the single-assessment process.
Possible outcomes are maintenance, variation, suspension or revocation of the marketing authorisation. For maintenance, the process ends at the Pharmacovigilance Risk Assessment Committee's recommendation. Other outcomes require further regulatory steps and, where applicable, a European Commission decision. The route depends on the authorisations involved. EMA sets out the outcomes and decision routes.
Holders must implement required action consistently and promptly across affected EU products. Read the applicable outcome and implementation instructions rather than assume one variation deadline applies to every PSUSA. EMA's guidance explains these obligations.
Reading an assessment outcome for your product
When checking a PSUSA outcome, keep the substance-level assessment separate from your own product's required action. Identify which products the outcome affects, then read the decision route and implementation instructions that apply. Do not stop at the outcome label: “variation” alone does not tell you what wording must change or when to act.
For internal tracking, record the reporting deadline separately from the action required after assessment. A published recommendation does not prove that every affected product label has changed. Use EMA's assessment guidance to distinguish those steps.
How does a PSUR differ from a DSUR?
A development safety update report, or DSUR, concerns investigational products and sponsor safety reporting. A PSUR concerns post-authorisation benefit-risk review by the marketing authorisation holder. Their schedules differ too. PSUR reporting follows the applicable schedule. Article 43 of the EU Clinical Trials Regulation requires an annual sponsor safety report for investigational medicinal products other than placebo.
Approval does not automatically end every development-reporting duty. A marketed medicine can remain under investigation. Article 43 places the sponsor's obligation between the first trial authorisation under that Regulation and the end of its last clinical trial with the investigational product. Do not assume a PSUR replaces a DSUR. The Clinical Trials Regulation and medicines directive address different reporting obligations.
RegAffairs AI's answer on PSURs covers EU submission timing and the distinction from DSURs.