Routes of the same type are on the same row. Compare other markets.
9 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, traditional or herbal registration 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 | Switzerland | Mexico |
|---|---|---|
| Full application, new active substance | Ordinary authorization of a medicine with a new active substanceArt. 11 HMG · target 330 days · fee CHF 80,000 | Registration of a medicine with a new moleculeCOFEPRIS-04-030 · fee MX$198,496 Registration of an innovative biotechnology medicineCOFEPRIS-04-030 |
| Full or mixed application, known active substance | 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 |
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 | 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 | Registration of a generic medicineCOFEPRIS-04-030 · fee MX$111,012 |
| Biosimilar application | Authorization of a biosimilarArt. 4 Abs. 1 Bst. anovies HMG · target 330 days · fee CHF 50,000 · relies on EU, US | Registration of a biocomparable (biosimilar) medicineCOFEPRIS-04-030 |
| 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 |
| 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 | Registration of herbal, homeopathic and vitamin medicinesCOFEPRIS-04-030 · fee MX$26,398 |
| 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 | 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 | 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 | Abbreviated reliance route for medicinesCOFEPRIS-04-040 · relies on US, EU, JP, CA, CH, WHO, BR Abbreviated reliance route for medical devicesCOFEPRIS-04-050 · relies on AU, BR, CA, CN, EU, JP, RU, SG, KR, CH, GB, US |
| Device: exempt or self-declared | - |
| 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 | Registration of a Class I medical deviceCOFEPRIS-04-060 · fee MX$16,499 Registration of a Class II medical deviceCOFEPRIS-04-060 · fee MX$24,198 Registration of a Class III medical deviceCOFEPRIS-04-060 · fee MX$30,798 Simplified registration of listed low-risk devicesCOFEPRIS-04-070 |
| 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 | Registration of a vaccine and lot releaseCOFEPRIS-04-030; COFEPRIS-05-031 |