Basic↦Drug or Device↦Therapeutic Products↦Orphan Drugs
What is it? Why is it important?
Orphan Drugs are:
- Medicinal Products for rare diseases (e.g. at most 5 out of 10,000 individuals in Switzerland are affected)
- Used to treat rare diseases that are:
- Life-Threatening or serious
- For which no treatment options or no satisfactory ones are available
Based on Swissmedic, a company may apply for so-called "orphan drug status" early during the development phase of the drug.
A product with orphan drug status:
- Profits from cost reductions during future authorisation procedures (no fees apply).
- Is only available for use after Swissmedic has authorised the drug for the rare disease in question. Thus, the recognition of an “orphan drug” status alone is not sufficient
As only a small fraction of the population is affected by rare diseases, the development of an orphan drug often depends on the support of the government and applicable agencies.
Where can I get help?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
External Links
Swissmedic – see in particular
- ZL100_00_002e_WL Guidance document Orphan Drug
Swiss Law
TPA – see in particular article
- Art. 4 Orphan drugs definition