PSUR and PBRER for Swiss authorisations
A PSUR re-evaluates the benefit-risk balance of a product over a defined interval. The content format is the PBRER under ICH E2C(R2). Swissmedic sets the submission interval per authorisation, and expectedness and label actions are assessed against the Swiss product information, which is why an EU report usually needs a Swiss annex.
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PSUR or PBRER?
PSUR names the regulatory obligation; PBRER names the format in which it is met. The PBRER replaced the older PSUR structure and requires an integrated benefit-risk appraisal rather than a case collection. In everyday use the two words are interchangeable.
Who submits, and how often?
The obligation falls on the marketing authorisation holder. Swissmedic sets the interval per authorisation, derived from the product, the international birth date and the risk profile. A new active substance reports more often than a long-established generic. The interval is a property of your authorisation, not a general rule, so read it from the authorisation documentation rather than assuming the EU cycle.
The structure of a PBRER
The chapter structure follows ICH E2C(R2) and moves from exposure through data to judgement. The order matters: a conclusion that does not follow from the sections above it is the most common substantive weakness in a submitted report.
- Worldwide authorisation status and actions taken in the reporting interval
- Estimated exposure, from clinical trials and from marketed use
- Interval and cumulative case data, tabulated and discussed
- Signals: new, ongoing and closed in the interval, with their outcome
- Evaluation of risks and new information, including the literature
- Benefit evaluation and the integrated benefit-risk analysis
- Conclusions and the actions proposed or already taken
Building blocks, data sources and lead times
Most late PSURs are not late because of the writing. They are late because one input arrived late. Fix the input dates and the report date takes care of itself.
| Building block | Source data | Who supplies it | Typical lead time |
|---|---|---|---|
| Exposure, marketed use | Sales and distribution data | Commercial, distributor | 3 to 4 weeks |
| Exposure, trials | Clinical database | Clinical operations | 2 to 3 weeks |
| Case line listings | Safety database | Pharmacovigilance | 1 to 2 weeks |
| Literature section | Search results for the interval | Information specialist | 2 weeks |
| Signal section | Signal log | RPPV, safety physician | 1 to 2 weeks |
| Label status and actions | Swiss product information and variations | Regulatory affairs | 2 weeks |
| Benefit-risk section | All of the above | Medical writing, RPPV | 2 to 3 weeks |
Swiss specifics
Four things differ from an EU report and all four are easy to forget. Expectedness is assessed against the Swiss product information. Swiss exposure is reported separately where it is available. Swiss actions, such as a label variation or a letter to professionals, are described even where the EU took none. And the submission route and the interval are Swiss, so an EU submission does not discharge the Swiss obligation.
The Swiss annex approach
Reusing the global PBRER and adding a Swiss annex covering exposure, label status, Swiss cases and Swiss actions is accepted practice and far cheaper than writing a second report. What is not acceptable is submitting the EU report unchanged and hoping the differences do not matter.
A 90 day plan that holds
Work backwards from the submission date. The plan below assumes a report you have written before; a first PSUR for a product needs an extra two weeks for the data cut definitions alone.
- Day 90 to 75: confirm the data lock point, request exposure data and run the interval literature search.
- Day 75 to 60: pull line listings, close the signal log for the interval and collect the label status.
- Day 60 to 35: draft the sections, with the benefit-risk analysis written last.
- Day 35 to 20: medical and regulatory review, and reconcile the numbers across sections.
- Day 20 to 10: RPPV sign-off and preparation of the submission package.
- Day 10 to 0: submit, log the receipt and open the tracker for any questions.
A late PSUR is a system finding
Swissmedic does not read a missed submission date as an administrative slip. A late periodic report says the holder cannot plan its own obligations, and it invites a closer look at everything else. If a date will be missed, say so before it passes, with a reason and a new date.
Frequently asked questions
Can we submit our EU PSUR unchanged in Switzerland?
Not unchanged. The global report can be reused, but expectedness has to be assessed against the Swiss product information and Swiss exposure, Swiss cases and Swiss actions have to be covered. In practice that is a Swiss annex attached to the global report.
Who decides the submission interval?
Swissmedic sets it per authorisation, based on the product, its international birth date and its risk profile. Take the interval from your authorisation documentation rather than from the EU reference date list.
Who has to sign the PSUR?
The RPPV signs off before submission. That signature is a statement that the report reflects the safety data the holder possesses, so the RPPV needs access to the underlying data, not only to the draft.
What if there were no cases in the interval?
You still submit. A report with no cases is a legitimate report and says something useful about exposure and detection. What is not acceptable is silence, or a report that omits the exposure estimate because there were no cases.
Does a PSUR replace individual case reporting?
No. Individual cases from Switzerland go to Swissmedic on the 15 and 60 day deadlines regardless of the PSUR. The PSUR aggregates and evaluates; it does not substitute for reporting.
Do you need an RPPV in Switzerland?
We act as the qualified person responsible for pharmacovigilance, run case processing and write the PSURs for your Swiss authorisations.