Routes of the same type are on the same row. Compare other markets.
15 pathway types exist in both markets: full application, new active substance, full or mixed application, known active substance, generic application, biosimilar application, well-established use, non-prescription application and more. The table lines up the routes of each type.
Spain: Centralised marketing authorisation, new active substance, 210 days. Switzerland: Ordinary authorization of a medicine with a new active substance, 330 days. These are official targets, not actual review times.
| Pathway type | Spain | Switzerland |
|---|---|---|
| Full application, new active substance | Centralised marketing authorisation, new active substancetarget 210 days · fee €865,200 Centralised authorisation of advanced therapy medicinal productstarget 210 days · fee €865,200 | Ordinary authorization of a medicine with a new active substanceArt. 11 HMG · target 330 days · fee CHF 80,000 |
| Full or mixed application, known active substance |
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.
Simplified authorization of a known active substance with innovationArt. 14 Abs. 1 Bst. a HMG; Art. 12-14 VAZV · target 330 days · fee CHF 30,000 |
| Generic application | Centralised generic applicationtarget 210 days · fee €177,900 | Simplified authorization of a generic (known active substance without innovation)Art. 14 Abs. 1 Bst. a HMG; Art. 12-14 VAZV · target 330 days · fee CHF 15,000 |
| Biosimilar application | National authorization of a biosimilarfee €8,736 Centralised biosimilar applicationtarget 210 days · fee €732,400 | Authorization of a biosimilarArt. 4 Abs. 1 Bst. anovies HMG · target 330 days · fee CHF 50,000 · relies on EU, US |
| Well-established use | Centralised well-established use applicationtarget 210 days · fee €780,900 | Simplified authorization for active substances used for ten years in the EU or EFTAArt. 14 Abs. 1 Bst. abis HMG; Art. 17a-17b VAZV · target 330 days · relies on EU Simplified authorization for long-used non-prescription medicinesArt. 14 Abs. 1 Bst. ater HMG; Art. 17c VAZV · target 330 days · relies on EU |
| Non-prescription application | Non-prescription status: dispensing category and switchArt. 23-23a HMG; Art. 40-44 VAM · target 270 days |
| Traditional or herbal registration | Simplified authorization of herbal and complementary medicinesArt. 14 Abs. 1 Bst. b und cbis HMG · target 120 days · fee CHF 3,000 |
| Conditional or accelerated approval | Conditional marketing authorisationtarget 210 days | Temporary authorization (incomplete data)Art. 9a HMG; Art. 18-22 VAZV · target 140 days · fee CHF 80,000 |
| Approval under exceptional circumstances | Authorisation under exceptional circumstancestarget 210 days | - |
| Priority or accelerated review | Accelerated assessmenttarget 150 days | Fast-track authorization procedureArt. 7 VAM · target 140 days |
| Intensive development support designation | - |
| Orphan or rare disease designation | Orphan designationtarget 90 days | Orphan drug status (important medicine for a rare disease)Art. 4 Abs. 1 Bst. adecies HMG; Art. 4-5 VAZV · target 210 days · relies on EU, US |
| Pediatric plan or incentive | Paediatric investigation plantarget 60 days | Pediatric investigation plan and pediatric incentivesArt. 54a HMG; Art. 5 VAM |
| Early or compassionate access | Exceptional authorization of a device without conformity assessmentArt. 22 MepV; Art. 18 IvDV |
| Reliance route, abridged review | - | Authorization based on a foreign authorization (Article 13 procedure)Art. 13 HMG; Art. 16-20 VAM · target 195 days · fee CHF 15,000 · relies on EU, US, GB, CA, AU, JP, SG |
| Reliance route, recognition or verification | Mutual recognition procedure involving Spaintarget 90 days · relies on EU Mutual recognition proceduretarget 90 days | - |
| Work-sharing or joint review | Decentralized procedure with Spain as reference member statetarget 120 days · fee €17,073 Decentralised proceduretarget 210 days | - |
| Device: exempt or self-declared | - |
| Device: premarket notification | - |
| Device: conformity assessment by a certification body | Medical device conformity assessment and placing on the marketArt. 45-47 HMG; MepV · relies on EU In vitro diagnostic device conformity assessment and placing on the marketIvDV · relies on EU |
| Device: registration or licence with the regulator | Registration of device economic operators and productsArt. 47 HMG; Art. 17 and 55 MepV |
| Other route | National scientific and regulatory advicetarget 90 days Integral drug-device combination authorised as a medicinetarget 210 days | Procedure with prior notification (20 percent shorter review for a double fee)Art. 7 GebV-Swissmedic · target 264 days Simplified authorization for a parallel importArt. 14 Abs. 2 und 3 HMG · target 330 days · fee CHF 4,000 |