Switzerland · Swissmedic · New drugs
Review target
195 days
official guidance
Legal time limit
-
Not published
Steps
8
7 requirements
Application fee
CHF 15,000
2026
If a medicine is already authorized in a country with comparable medicines control, Swissmedic takes the results of that country's review into account. For known active substances and for biosimilars authorized in the EU or the US, the agency does no scientific review of its own. For new active substances, it still runs a full review but can reduce it in justified cases. Medicines already authorized by a reference authority in Australia, Canada, the EU and EFTA states, Japan, New Zealand, Singapore, the United Kingdom or the United States, on request of the applicant.
The official review target is 195 days (official guidance). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The new authorization, known active substance without innovation (base fee before the 60 percent reduction) is CHF 15,000 for 2026.
1. Submit the application; 2. Formal control and technical validation (30 days); 3. Applicant corrects formal gaps (clock stopped) (60 days); 4. Evaluation phase I (60 days); 5. Applicant answers the list of questions (clock stopped) (45 days); 6. Evaluation phase II and preliminary decision (60 days); 7. Applicant replies to the preliminary decision (clock stopped) (45 days); 8. Labeling review and official decision (45 days).
Yes. It relies on approvals from Australia, Canada, European Union, United Kingdom, Japan, Singapore, United States (shorter review, shorter review, shorter review, shorter review, shorter review, shorter review, shorter review).
Outcome: Swiss authorization for five years, renewable. Valid for 5 years.
Legal basis: Therapeutic Products Act (HMG) Article 13; Therapeutic Products Ordinance (VAM) Articles 16 to 20; Fee Ordinance (GebV-Swissmedic) Article 10
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 285 days end to end with the official step targets, of which up to 150 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
| Longest clock stopofficial guidance. Total applicant time foreseen for known active substances without innovation. | 150 days |
| 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. This target applies to known active substances without innovation. The maximum total, including applicant time, is 345 days. New active substances under this procedure follow the standard 330-day target. | 195 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| New authorization, known active substance without innovation (base fee before the 60 percent reduction)Application · 2026 · Fees for applications handled under this procedure are 60 percent lower. | CHF 15,000 |
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, Fast-track authorization 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 (37 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.