Switzerland · Swissmedic · New drugs
Review target
140 days
official guidance
Legal time limit
-
Not published
Steps
10
4 requirements
Application fee
CHF 5,000
2026
Swissmedic can review a human medicine, or a change to one, faster when it promises to prevent or treat a severe, disabling or life-threatening disease, when treatment options are missing or unsatisfactory, and when a high therapeutic benefit is expected. The applicant first needs an approved fast-track request. The data required are the same as in the standard procedure. Promising new medicines or new indications for serious diseases with an unmet medical need.
The official review target is 140 days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The request for the fast-track procedure is CHF 5,000 for 2026.
1. Fast-track request; 2. Accelerated application hearing; 3. Submit the application on the agreed date; 4. Formal control and technical validation (5 days); 5. Applicant corrects formal gaps (clock stopped) (60 days); 6. Evaluation phase I (65 days); 7. Applicant answers the list of questions (clock stopped) (90 days); 8. Evaluation phase II and preliminary decision (50 days); 9. Applicant replies to the preliminary decision (clock stopped) (60 days); 10. Labeling review and official decision (20 days).
Outcome: Same authorization as in the standard procedure, after a shorter review.
Legal basis: Therapeutic Products Ordinance (VAM) Article 7; Fee Ordinance (GebV-Swissmedic) Article 6
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 346 days end to end with the official step targets, of which up to 210 days are clock stops (time the applicant uses to answer). Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetofficial guidance. Official target for agency time only, counted in calendar days. Time the applicant takes to answer is not counted. Actual review times can differ. The maximum total, including applicant time, is 350 days. | 140 days |
| Longest clock stopofficial guidance. Total applicant time foreseen in the fast-track procedure. | 210 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Request for the fast-track procedureDesignation · 2026 · In addition, the fees for the new authorization or new indication are 50 percent higher in this procedure. | CHF 5,000 |
Other routes in Switzerland: Ordinary authorization of a medicine with a new active substance, Simplified authorization of a known active substance with innovation, Simplified authorization of a generic (known active substance without innovation), Authorization of a biosimilar, Authorization based on a foreign authorization (Article 13 procedure), Procedure with prior notification (20 percent shorter review for a double fee), Temporary authorization (incomplete data), Orphan drug status (important medicine for a rare disease), Simplified authorization for active substances used for ten years in the EU or EFTA, Simplified authorization for long-used non-prescription medicines, Non-prescription status: dispensing category and switch, Simplified authorization of herbal and complementary medicines, Simplified authorization for a parallel import, Temporary permit for use outside clinical trials or limited marketing, Pediatric investigation plan and pediatric incentives. See all routes on the Switzerland page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (17 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.