Orphan drug market entry in Switzerland
For international biotech and pharmaceutical product owners: research Swiss orphan designations, authorisation holders and reimbursement pathways, then discuss your product’s Swiss entry needs.
Discuss your Swiss project
The data set in numbers
- 728orphan designations
- 321medicines with status
- 220rare diseases
- 16temporarily authorised
Three ways into the directory
How orphan drug status works in Switzerland
Application independent of authorisation
The application can be filed before, together with or after the authorisation application (Art. 4 para. 3 TPLO). No Swiss registered office is needed, only an address for deliveries.
Simplified procedure and priority
The status opens the simplified authorisation procedure under Art. 14 para. 1 let. f TPA. Authorisation applications for products with the status are processed as a priority.
Fee waiver
The flat-rate fee for the new authorisation application is waived (Art. 9 let. a FeeO-Swissmedic). Variations have been subject to fees since 2019.
15 years of document protection
On request Swissmedic grants 15 years of document protection (Art. 11b para. 4 TPA). Swiss law knows no market exclusivity of the kind granted in the EU.
Rare diseases Access
Every rare disease for which Swissmedic has granted at least one orphan drug status. The label follows the published orphan indication.
Recently granted status
| Status granted | Orphan indication | Active substance | Medicine |
|---|---|---|---|
| 25/08/2026 | Behandlung der primären IgA Nephropathie | ravulizumabum | Ultomiris |
| 03/08/2026 | Behandlung der spinalen Muskelatrophie | apitegromabum | Designation only |
| 17/07/2026 | Behandlung des Pankreaskarzinoms | daraxonrasibum | Designation only |
| 07/07/2026 | Behandlung des grosszelligen B-Zell Lymphoms (LBCL) | surovatamigum | Designation only |
| 25/06/2026 | Traitement du déficit héréditaire en facteur X | factor X coagulationis humanus | Designation only |
| 25/06/2026 | Behandlung des Uveitischen Makulaödems | vamikibartum | Designation only |
Temporary authorisations
Medicines with a temporary authorisation under Art. 9a TPA: authorised with conditions because no equivalent alternative is available for a life-threatening disease.
Guides
Orphan drug status, authorisation, reimbursement and care in Switzerland, explained with the relevant articles of the TPA, TPLO and KVV.
Bring your orphan drug to Switzerland
You can enquire about orphan drug status, authorisation and reimbursement in Switzerland. Any specialist service and its scope are agreed separately with the external partner.
- Public Swissmedic data
- Four language versions
Frequently asked questions
How does a medicine obtain orphan drug status in Switzerland?
On application to Swissmedic. It requires a life-threatening or chronically debilitating disease affecting no more than 5 in 10,000 people in Switzerland, or an existing recognition in a country with comparable medicinal product control (Art. 4 para. 1 let. a decies TPA, Art. 4 TPLO).
What does the status actually give you?
The simplified authorisation procedure (Art. 14 para. 1 let. f TPA), priority assessment, a waiver of the flat-rate fee for the new authorisation application and, on request, 15 years of document protection (Art. 11b para. 4 TPA). There is no market exclusivity as in the EU.
How current is the data on Swiss Orphan Access?
Swissmedic publishes the list of medicinal products with orphan drug status under Art. 7 TPLO and updates it monthly. The date of the data set processed here is shown at the foot of every page.