PSUR and PBRER writing for Swiss authorisations
External providers produce the periodic safety report for your Swiss authorisations: interval data, exposure estimation, literature integration, the signal section, the integrated benefit-risk evaluation and the Swiss annex. Written to ICH E2C(R2), signed off by the RPPV and submitted on the interval Swissmedic set for your authorisation.
- Last reviewed:
- Reading time: 3 min
- Reviewed by Swiss Pharmacovigilance
What this service is
A medical writing and regulatory service that turns your safety data into a submitted report. External providers can write the whole PBRER or produce only the Swiss annex to a global report, which is the cheaper and more common route for a holder that already reports in the EU.
What you get
- A planning calendar working back from the submission date
- Exposure estimation from sales and clinical data, with the method stated
- Case line listings and summary tabulations for the interval
- The interval literature section, integrated rather than appended
- The signal section, reconciled with your signal log
- An integrated benefit-risk evaluation with conclusions and proposed actions
- A Swiss annex covering Swiss exposure, label status and Swiss actions
- Submission, plus the drafting of answers to any Swissmedic questions
How external providers run it
- Confirm the data lock point and the submission date from your authorisation.
- Request the inputs with dated deadlines: exposure, listings, label status.
- Run the interval literature search, or take yours and assess it.
- Draft the sections, writing the benefit-risk analysis last.
- Reconcile every number across sections, then medical and regulatory review.
- RPPV sign-off, submission and the receipt filed.
- Track and answer any questions, and feed the outcome into the next interval.
What external providers need from you
- The authorisation documentation stating the submission interval
- Exposure data: Swiss sales or distribution volumes for the interval
- Access to the case data, or the line listings themselves
- The current and previous Swiss product information versions
- Any actions taken in other markets during the interval
| Building block | Who drafts | Who reviews | Lead time |
|---|---|---|---|
| Exposure estimate | external PV providers | Your commercial contact | 3 weeks |
| Line listings and tabulations | external PV providers | RPPV | 2 weeks |
| Literature section | external PV providers | Safety physician | 2 weeks |
| Signal section | external PV providers | RPPV | 2 weeks |
| Label and action status | Your regulatory contact | external PV providers | 2 weeks |
| Benefit-risk evaluation | external PV providers | RPPV, your medical lead | 3 weeks |
| Swiss annex | external PV providers | RPPV | 1 week |
Onboarding
- Week 1: confirm the interval, the data lock point and the submission date.
- Week 1 to 2: input owners named on your side, deadlines agreed in writing.
- Week 2: template and previous report reviewed, gaps listed.
- Week 3 onwards: the standard 90 day production cycle begins.
Pricing model
A fixed fee per report, banded by the interval length, the case volume and whether external providers write the full PBRER or only the Swiss annex. Answering Swissmedic questions is quoted as a day rate, because the effort depends entirely on what is asked.
Frequently asked questions
Can you just write the Swiss annex?
Yes, and for a holder already reporting in the EU that is usually the right scope. External providers take your global PBRER and add Swiss exposure, Swiss label status, Swiss cases and Swiss actions, assessed against the Swiss product information.
What does a PSUR cost?
A fixed fee per report, banded by interval length, case volume and whether it is a full PBRER or a Swiss annex. You get the figure before external providers start, and it does not move unless the scope does.
How much lead time do you need?
Ninety days for a full report you have not written before, sixty for a repeat cycle, and about four weeks for a Swiss annex to an existing global report. The binding constraint is usually your exposure data.
Who signs the report?
The RPPV signs off before submission. If external providers hold your RPPV role, external providers sign; if not, external providers deliver the report and the underlying data for your RPPV to sign.
Who is responsible if the report is late?
You remain accountable to Swissmedic. Provider planning works back from the submission date with dated input deadlines precisely so a late input is visible weeks before it becomes a late report.
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.