Routes of the same type are on the same row. Compare other markets.
11 pathway types exist in both markets: full application, new active substance, full or mixed application, known active substance, generic application, biosimilar application, non-prescription application, conditional or accelerated approval and more. The table lines up the routes of each type.
United States: New drug application (full, new active ingredient), 304 days. Switzerland: Ordinary authorization of a medicine with a new active substance, 330 days. These are official targets, not actual review times.
| Pathway type | United States | Switzerland |
|---|---|---|
| Full application, new active substance | New drug application (full, new active ingredient)505(b)(1) · target 304 days · fee $4,600,753 Biologics license application (351(a))351(a) BLA · target 304 days · fee $4,600,753 | 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 | New drug application relying on other data (505(b)(2))505(b)(2) · target 304 days · fee $2,300,376 |
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.
| Generic application | Abbreviated new drug application (generic)505(j) ANDA · target 304 days · fee $375,684 | 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 | Biosimilar application (351(k))351(k) BLA · target 304 days · fee $1,124,936 | Authorization of a biosimilarArt. 4 Abs. 1 Bst. anovies HMG · target 330 days · fee CHF 50,000 · relies on EU, US |
| Well-established use | - | 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 |
| Non-prescription monograph | Over-the-counter monograph orderOMOR · fee $614,608 | - |
| 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 | Temporary authorization (incomplete data)Art. 9a HMG; Art. 18-22 VAZV · target 140 days · fee CHF 80,000 |
| Priority or accelerated review | Priority reviewtarget 183 days | Fast-track authorization procedureArt. 7 VAM · target 140 days |
| Intensive development support designation | - |
| Rolling or phased review | - |
| Orphan or rare disease designation | 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 | Pediatric investigation plan and pediatric incentivesArt. 54a HMG; Art. 5 VAM |
| Emergency or temporary authorisation | - |
| 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 |
| Device: exempt or self-declared | - |
| Device: premarket notification | Premarket notification (510(k))510(k) · target 90 days · fee $28,653 | - |
| Device: new low or moderate risk device | De Novo classification request513(f)(2) · target 150 days · fee $191,020 | - |
| Device: premarket approval by the regulator | Premarket approval (PMA)PMA · target 180 days · fee $636,732 | - |
| 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 |
| Device: breakthrough or priority program | - |
| Device: humanitarian or limited population route | - |
| Other route | 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 |