Switzerland · Swissmedic · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
2
4 requirements
Application fee
-
Applications for a new active substance, an orphan medicine with a new substance, or a new indication, form or route of such products must include a pediatric investigation plan. A plan approved by a comparable foreign authority is accepted. Medicines developed only for children can get ten years of data protection, and their authorization fee is waived. Development of new medicines and their line extensions.
1. Submit the plan; 2. Approval, waiver or deferral.
Outcome: An approved plan, a waiver or a deferral.
Legal basis: Therapeutic Products Act (HMG) Articles 11b and 54a; Therapeutic Products Ordinance (VAM) Article 5; Fee Ordinance Article 9
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).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
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), 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. See all routes on the or explore them in the .
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 (6 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.