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.
Spain: Centralised marketing authorisation, new active substance, 210 days. These are official targets, not actual review times.
| Pathway type | Spain | Mexico |
|---|---|---|
| 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 | 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.
Centralised marketing authorisation, known active substance or new fixed combinationtarget 210 days · fee €690,700 Centralised hybrid applicationtarget 210 days · fee €426,100 |
| Generic application | Centralised generic applicationtarget 210 days · fee €177,900 | Registration of a generic medicineCOFEPRIS-04-030 · fee MX$111,012 |
| Biosimilar application | National authorization of a biosimilarfee €8,736 Centralised biosimilar applicationtarget 210 days · fee €732,400 | Registration of a biocomparable (biosimilar) medicineCOFEPRIS-04-030 |
| Well-established use | Centralised well-established use applicationtarget 210 days · fee €780,900 | - |
| Non-prescription application |
| Traditional or herbal registration | Registration of herbal, homeopathic and vitamin medicinesCOFEPRIS-04-030 · fee MX$26,398 |
| Conditional or accelerated approval | Conditional marketing authorisationtarget 210 days | - |
| Approval under exceptional circumstances | Authorisation under exceptional circumstancestarget 210 days | - |
| Priority or accelerated review | Accelerated assessmenttarget 150 days | - |
| Intensive development support designation | - |
| Orphan or rare disease designation | Orphan designationtarget 90 days | - |
| Pediatric plan or incentive | Paediatric investigation plantarget 60 days | - |
| 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 |
| 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 | - |
| 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 |
| Other route | National scientific and regulatory advicetarget 90 days Integral drug-device combination authorised as a medicinetarget 210 days | Registration of a vaccine and lot releaseCOFEPRIS-04-030; COFEPRIS-05-031 |