Clinical trials in Switzerland
Every clinical trial in Switzerland needs approval from the competent cantonal ethics committee. Trials in categories B and C for medicines, and category C for devices, additionally need a Swissmedic authorisation. The two reviews run in parallel, and the ethics committee decides within 30 working days of a complete dossier.
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What counts as a clinical trial?
Under the Human Research Act, a clinical trial is a research project in which people are prospectively assigned to a health-related intervention in order to study its effects. That covers medicines and medical devices, but also other interventions such as a physiotherapy regimen or a diagnostic procedure.
Who authorises what?
Two bodies are involved, with different remits. The cantonal ethics committee reviews every trial: its scientific quality, the risk-benefit balance, consent, data protection and insurance. Swissmedic reviews the product: quality, preclinical and clinical safety data, and the manufacturing of the investigational product. Category A needs the ethics committee only.
The legal frame in short
The Human Research Act (HRA, SR 810.30) is the framework act: consent, dignity, data protection, categorisation, the ethics committees and the registration duty. The Clinical Trials Ordinance (ClinO, SR 810.305) adds the procedure, the deadlines, safety reporting and sponsor duties. Device trials run under ClinO-MD. On top of that sit ICH GCP and the Declaration of Helsinki, which the ordinance references as the state of the art.
From protocol to first patient
The sequence is always the same, and the order matters: categorise first, because the category decides which authorisations you need and therefore which dossier you assemble. Skipping that step is the most expensive mistake in a Swiss submission.
| Step | Body | Instrument | Typical duration |
|---|---|---|---|
| Categorisation and pre-submission advice | Sponsor, optionally the committee and Swissmedic | ClinO | 1 to 3 weeks |
| Assembling the dossier | Sponsor | ClinO, ICH GCP | 4 to 8 weeks |
| Submission through BASEC | Ethics committee | HRA, ClinO | 1 day |
| Swissmedic application, categories B and C | Swissmedic | ClinO | 1 day, in parallel |
| Formal completeness check | Both bodies | ClinO | Up to 7 working days |
| Review and questions | Both bodies | ClinO | 30 working days at the committee |
| Decision, then site initiation | Sponsor | Contracts, ICH GCP | 2 to 4 weeks |
What is different from the EU
Switzerland sits outside the EU Clinical Trials Regulation and outside CTIS. An EU authorisation does not transfer, and a CTIS submission does not reach the Swiss authorities. You file a separate national submission, and a sponsor established abroad needs a representative in Switzerland. Documents you already hold, such as the protocol and the investigator's brochure, can be reused, but the application forms, the consent documents and the insurance certificate are Swiss specific.
Language versions are not an afterthought
Consent documents have to be available in the language of the participants at each site. In a trial running in Zurich, Lausanne and Lugano that means three versions, reviewed and consistent with each other. Missing language versions are one of the most common reasons a dossier is not accepted as complete, and an incomplete dossier does not start the 30 day clock.
Duties that run during the trial
Authorisation is the start, not the end. Over the trial life cycle the sponsor owes a stream of notifications, and every one of them has its own deadline and its own addressee. Build them into the trial master file from day one rather than reconstructing them at the end.
- Substantial amendments: submitted for approval before implementation
- SUSARs: 7 days if fatal or life threatening, 15 days otherwise, to Swissmedic and the ethics committee
- Safety and protective measures taken urgently: notified without delay
- The annual safety report for the duration of the trial
- Notification of the end of the trial, and of any premature termination with its reasons
- The final report, and the registration of results in the register used
Frequently asked questions
Do I need a Swiss submission if the trial is already authorised in the EU?
Yes. Switzerland is a third country for the EU Clinical Trials Regulation and does not take part in CTIS. The ethics committee approval and, for categories B and C, the Swissmedic authorisation have to be obtained nationally. The scientific documents can be reused.
Can we start as soon as the ethics committee has approved?
Only in category A. In categories B and C both the ethics committee approval and the Swissmedic authorisation have to be in place before the first participant is enrolled.
Does a foreign sponsor need a Swiss representative?
Yes. The authority and the ethics committee need a contact who is reachable in Switzerland and who can answer for the sponsor's duties. That representation is documented in the application.
Which ethics committee is competent?
The committee of the canton in which the trial is conducted. In a multicentre trial one committee leads the procedure and the committees of the other sites are involved through it.
Does an observational study need the same procedure?
A research project without a prospective assignment to an intervention is not a clinical trial in the ClinO sense, but it still needs an ethics committee decision under the HRA. The category and the dossier are lighter, and Swissmedic is not involved.
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.