Swiss clinical trial timelines and fees

Timelines and fees for clinical trials in Switzerland

Two clocks run in a Swiss submission: the ethics committee, which decides within 30 working days of a complete dossier, and Swissmedic, which reviews in parallel for categories B and C. From a finished protocol to the first participant, plan on three to five months, most of which is yours rather than the authority's.

Last reviewed: 2026-09-17

Reading time: 5 min

Reviewed by Swiss Pharmacovigilance

Two parallel clocks

The ethics committee and Swissmedic review at the same time, each with its own completeness check and its own questions. Your submission is only as fast as the slower of the two, and both stop counting while they wait for an answer from you.

A realistic calendar to first patient

The calendar below assumes a finished protocol and a sponsor who has done this before in Switzerland. A first Swiss trial, an unusual design or a borderline category adds two to four weeks, almost all of it before submission.

Weeks 1 to 2: categorise the protocol, and take pre-submission advice where anything is borderline.
Weeks 1 to 3: appoint the Swiss sponsor representative and arrange the trial insurance.
Weeks 2 to 8: assemble the dossier, including every language version of the participant documents.
Week 8: file through BASEC and, for categories B and C, file with Swissmedic in parallel.
Weeks 8 to 9: the formal completeness check, which is when a thin dossier comes back.
Weeks 9 to 15: the substantive review, up to 30 working days at the committee, plus your answers to questions.
Weeks 15 to 19: decisions, site contracts, site initiation and the first participant.

The phases at a glance
Phase	Who owns it	Working days	What delays it
Categorisation and advice	Sponsor	5 to 15	An unclear category, no pre-submission contact
Dossier assembly	Sponsor	20 to 40	Missing language versions, late insurance confirmation
Completeness check	Committee and Swissmedic	Up to 7	An incomplete dossier, which does not start the clock
Substantive review	Committee and Swissmedic	Up to 30 at the committee	Questions, which suspend the deadline
Answering questions	Sponsor	5 to 15	Partial answers that trigger a second round
Contracts and initiation	Sponsor and sites	10 to 20	Site contract negotiation, delegation and training logs

Fees: the structure

Two fees fall due, from two bodies, on two bases. Swissmedic charges an authorisation fee per application according to the fee ordinance in force, for categories B and C. The ethics committee charges according to its own published tariff, which is set per committee and is higher for a multicentre trial than for a single site. Amendments are charged separately, so a protocol that is amended twice during the trial carries three fee events, not one.

Swissmedic authorisation fee per application, categories B and C, per the current fee ordinance
Ethics committee fee per the committee's own published tariff
A higher committee tariff for multicentre trials than for a single site
Separate fees for substantial amendments at both bodies
No authority fee for a category A trial at Swissmedic, since it does not authorise

Check the current figures at the source

Fee amounts change with the fee ordinance and with each committee's tariff decisions. Before you budget, take the figures from the Swissmedic fee pages and from the tariff published by the competent ethics committee rather than from a secondary source.

What actually delays a Swiss submission

In practice the authorities are rarely the bottleneck. Almost all lost time sits in the weeks before submission and in the quality of the answers to questions. The list below is in order of how often it bites.

An incomplete dossier, which fails the completeness check and does not start the 30 day clock
Missing or inconsistent language versions of the participant information and consent form
A Swiss insurance confirmation that arrives after everything else is ready
An unclear categorisation that has to be settled during the review instead of before it
A sponsor representative in Switzerland appointed late, holding up the application itself
Partial answers to questions, which trigger a second round and cost more than they saved

Amendments during the trial

A substantial amendment has to be approved before it is implemented, which means it carries its own review and its own timeline. Plan six to ten weeks for one that touches the protocol, the consent documents or the investigational product, and remember that an amendment adding an off-label arm can change the risk category and bring Swissmedic into a trial it had not authorised before.

Frequently asked questions

How long does the ethics committee really take?

The ordinance sets a maximum of 30 working days from confirmation that the dossier is complete. Straightforward trials often come back faster. Questions suspend the deadline, so the practical duration depends on your answers as much as on the committee.

What does a Swiss clinical trial application cost?

Swissmedic charges an authorisation fee per application for categories B and C according to the fee ordinance in force, and the competent ethics committee charges according to its own published tariff, higher for multicentre trials. Take the current amounts from those two sources when you budget.

Can we shorten the timeline by filing earlier with a thinner dossier?

No. An incomplete dossier fails the completeness check, which means the 30 working days never start. Filing two weeks later with a complete dossier is almost always faster overall.

Do amendments have to be approved before we implement them?

Substantial amendments do. Minor changes are notified rather than approved. If you are unsure which you are dealing with, treat it as substantial and ask, because implementing an unapproved substantial amendment is a serious GCP finding.

When can site initiation start?

Prepare contracts, training and supplies in parallel with the review, but do not enrol a participant before both decisions are in hand, and in category A before the committee decision. Initiation visits themselves can be scheduled conditionally.