Literature monitoring for Swiss authorisations
Published safety information counts as information the holder possesses, so it has to be looked for systematically. That means a documented search strategy across Embase and Medline plus the Swiss trade press, a defined cadence, an assessed hit log, and an ICSR wherever a publication describes an identifiable patient in Switzerland.
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- Reviewed by Swiss Pharmacovigilance
Why literature monitoring is a duty
Pharmacovigilance obliges a holder to act on the safety information available to it. Published literature is available by definition, so not looking is not a defence. The deliverable is a reproducible search strategy: someone else running your documented search should get your results.
What has to be searched
Two international databases and the local press cover most of the obligation. Embase and Medline between them capture the journal literature, while the Swiss trade and professional press carries case reports and regulatory commentary that never reaches an international index. Add any product-specific source that matters for your therapeutic area.
- Embase and Medline, with product and substance search strings per product
- The Swiss trade and professional press for the relevant specialties
- Congress abstracts where your product is presented
- Publications named in your licensor's global search output
- Preprints and regulatory bulletins where they are material to the product
Cadence and documentation
Weekly is the practical standard for a marketed product, because a 15 day deadline leaves little room for a monthly cycle. What has to be documented is not only the hits but the search itself: strings, databases, date ranges and the person who ran it.
- Define the search strategy per product: strings, databases, limits, and justify the choices.
- Run the search on the defined cadence and record date, operator and result count.
- Log every hit and assess it: relevant, not relevant, or a potential case.
- Create an ICSR where a publication describes an identifiable patient in Switzerland.
- Feed the remaining relevant hits into signal management and the PSUR.
- Archive the search output, the assessments and the full text of the relevant articles.
Source, cadence, ownership, retention
The table is the operational core of the obligation. Filling it in for your own portfolio is most of what a literature SOP needs to say.
| Source | Cadence | Who runs it | Retention |
|---|---|---|---|
| Embase and Medline | Weekly | PV or information specialist | Search output and assessments, archived |
| Swiss trade press | Weekly to monthly | PV | Clippings and assessments |
| Congress abstracts | Per congress | Medical affairs | Abstract and assessment |
| Licensor global search | Per the SDEA cadence | Licensor, received by PV | Received output and the Swiss assessment |
| Ad hoc product searches | On a signal or a question | PV | Search record with the question asked |
When a literature hit becomes an ICSR
A publication becomes a reportable case when it describes an identifiable patient, an identifiable product and a reaction, with the author as the reporter. Day 0 is the day you became aware of the publication, which is the day your search surfaced it, not the day you obtained the full text. That is why a weekly search with a two week full-text delay still meets a 15 day deadline, and a monthly one does not.
The strategy is the deliverable, not the hit list
An inspector rarely questions whether you found a particular paper. They ask whether your search could have found it. A documented, reproducible strategy with justified search strings answers that; a folder of PDFs does not.
Frequently asked questions
Is weekly searching mandatory?
The ordinance sets the duty, not the interval. Weekly is the practical standard for a marketed product because the 15 day deadline leaves little slack. A longer interval needs a documented justification, and it rarely survives a serious case.
Can we rely on our licensor's global literature search?
You can use it, and it makes sense not to duplicate work. Set the scope, cadence and delivery in the SDEA, and document your own assessment of what they send, including whether their search covers the Swiss sources.
Do we have to report every case found in the literature?
You report cases with an identifiable patient in Switzerland, on the usual deadlines. Foreign literature cases feed the PSUR and signal management instead of individual submission.
What counts as an identifiable patient in a publication?
Enough detail to distinguish an individual, typically age, sex and a clinical course, even without a name. An aggregate statement about a cohort is not an individual case.
How long do we keep the search records?
Keep them for the retention period that applies to your pharmacovigilance records, which extends well beyond the reporting interval. The search record is the evidence that the duty was met, so it outlives the hits it produced.
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.