Routes of the same type are on the same row. Compare other markets.
7 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, device: exempt or self-declared and more. The table lines up the routes of each type.
United States: New drug application (full, new active ingredient), 304 days. These are official targets, not actual review times.
| Pathway type | United States | Mexico |
|---|---|---|
| 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 | 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 |
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 | Registration of a generic medicineCOFEPRIS-04-030 · fee MX$111,012 |
| Biosimilar application | Biosimilar application (351(k))351(k) BLA · target 304 days · fee $1,124,936 | Registration of a biocomparable (biosimilar) medicineCOFEPRIS-04-030 |
| Non-prescription application |
| Non-prescription monograph | Over-the-counter monograph orderOMOR · fee $614,608 | - |
| Traditional or herbal registration | - | Registration of herbal, homeopathic and vitamin medicinesCOFEPRIS-04-030 · fee MX$26,398 |
| Conditional or accelerated approval | - |
| Priority or accelerated review | Priority reviewtarget 183 days | - |
| Intensive development support designation | - |
| Rolling or phased review | - |
| Orphan or rare disease designation | - |
| Pediatric plan or incentive | - |
| Emergency or temporary authorisation | - |
| Early or compassionate access | - |
| Reliance route, abridged review | - | 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: 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: registration or licence with the regulator | - | 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 |
| Device: breakthrough or priority program | - |
| Device: humanitarian or limited population route | - |
| Other route | Registration of a vaccine and lot releaseCOFEPRIS-04-030; COFEPRIS-05-031 |