The authorisation procedure for clinical trials
A Swiss clinical trial runs on two tracks. The ethics committee application goes through BASEC, the swissethics submission platform. For categories B and C a Swissmedic application is filed in parallel. The committee decides within 30 working days of confirming that the dossier is complete.
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The two track procedure
Track one is the competent cantonal ethics committee, which reviews the project on people: consent, risk-benefit, data protection, insurance, site suitability. Track two is Swissmedic, which reviews the investigational product. The tracks run at the same time, not one after the other, and each issues its own decision.
What is BASEC?
BASEC is the electronic submission portal run by swissethics for every application to a Swiss ethics committee. It carries the initial application, amendments, safety notifications, annual reports and the end-of-trial notification, and keeps the history of the project in one place. The sponsor or an authorised representative submits; the committee itself decides outside the platform.
- Application form with the project categorisation and the sites
- Protocol with a synopsis, and the statistical analysis plan
- Investigator's brochure or, for an authorised product, the product information
- Participant information and consent form, in every site language
- Insurance certificate covering the trial
- Investigator CVs and evidence of GCP training
- Case report form, recruitment material and, where relevant, the data management plan
The Swissmedic application
For categories B and C the Swissmedic application covers the investigational medicinal product: quality and manufacturing, preclinical data, the clinical safety data available so far and the risk assessment. The core document is the IMPD, alongside the protocol and the investigator's brochure. The sponsor, or the representative in Switzerland, is named as the applicant.
The submission step by step
The sequence below is what keeps a Swiss submission inside its expected timeline. Nothing in it is optional except the pre-submission advice, which is the cheapest week you will ever spend on a Swiss trial.
- Categorise the protocol and, where there is doubt, ask the committee or Swissmedic for pre-submission advice.
- Appoint the sponsor representative in Switzerland and take out the trial insurance.
- Assemble the dossier, including every language version of the participant documents.
- File through BASEC and, for categories B and C, file the Swissmedic application in parallel.
- Answer the completeness check, then the substantive questions, inside the deadline given.
- Collect both decisions, sign the site contracts and initiate the sites.
| Component | Ethics committee | Swissmedic | Language |
|---|---|---|---|
| Protocol and synopsis | Yes | Categories B and C | National language or English |
| Investigator's brochure or product information | Yes | Categories B and C | National language or English |
| IMPD, quality and manufacturing | No | Categories B and C | English accepted |
| Participant information and consent | Yes | No | Every site language |
| Insurance certificate | Yes | No | National language |
| Investigator CVs and GCP evidence | Yes | No | National language or English |
| Recruitment material | Yes | No | Every site language |
The 30 working days, and what stops the clock
The ethics committee decides at the latest within 30 working days of confirming that the submitted documents are complete. That confirmation is the trigger, which is why an incomplete dossier does not simply delay the review: it does not start it. Questions from the committee suspend the clock until you answer, so a fast, complete response is worth more than a fast submission.
Use the pre-submission advice
Both the committees and Swissmedic will discuss a protocol before it is filed. For an unusual design, a borderline category or a first-in-Switzerland product, that conversation routinely saves a whole review cycle.
Multicentre trials
In a multicentre trial one ethics committee leads the procedure and issues the decision, while the committees of the other sites are involved through it. You file once, not once per canton, but each site still needs its own contract, its own insurance confirmation and its own language version of the participant documents.
Frequently asked questions
Can we submit to Swissmedic and the ethics committee at the same time?
Yes, and you should. The two reviews are designed to run in parallel. Filing sequentially adds weeks without improving either review.
In which language do we submit?
The scientific dossier is generally accepted in a national language or in English. The participant information and consent form have to be in the language of the participants at each site, so a trial across the language regions needs several versions.
What happens if the committee asks questions?
The clock is suspended until your answer arrives. Answer completely rather than quickly: a partial answer triggers a second round and costs more time than the days you saved.
Who may file through BASEC?
The sponsor or a person authorised by the sponsor, for example a CRO or the Swiss representative. The authorisation has to be documented, and the account should not rest with one individual only.
Does a category A trial need anything from Swissmedic?
No. Category A needs the cantonal ethics committee decision only. Swissmedic is not involved in the authorisation, although the ordinary pharmacovigilance duties for the authorised product continue to apply.
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.