Routes of the same type are on the same row. Compare other markets.
12 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.
Switzerland: Ordinary authorization of a medicine with a new active substance, 330 days. These are official targets, not actual review times.
| Pathway type | Brazil | Switzerland |
|---|---|---|
| Full application, new active substance | Registration of a new medicinefee R$157,416 | 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 | Registration of an innovative medicinefee R$37,231 |
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 | Registration of a generic medicinefee R$11,714 Registration of a similar medicinefee R$41,000 | 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 | 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 | - |
| 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 | Fast-track authorization procedureArt. 7 VAM · target 140 days |
| Orphan or rare disease designation | Special procedure for new medicines for rare diseasestarget 60 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 | - | 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 | Optimized analysis using an equivalent foreign authorityrelies on EU, CA, WHO, CH, GB, US, AU, JP Optimized analysis for class III and IV devices approved abroadrelies on AU, CA, US, JP | 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: premarket notification | Notification of a class I or II medical devicetarget 30 days | - |
| 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 a class III or IV medical devicetarget 320 days · fee R$39,048 Registration of a class III or IV in vitro diagnostic devicetarget 365 days · fee R$15,619 Software as a medical device (notification or registration)target 250 days | Registration of device economic operators and productsArt. 47 HMG; Art. 17 and 55 MepV |
| Other route | Good manufacturing practice certification (CBPF)target 365 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 |