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.
European Union: Centralised marketing authorisation, new active substance, 210 days. These are official targets, not actual review times.
| Pathway type | European Union | 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.
| Generic application | Centralised generic applicationtarget 210 days · fee €177,900 | Registration of a generic medicineCOFEPRIS-04-030 · fee MX$111,012 |
| Biosimilar application | 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 | - |
| 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 proceduretarget 90 days | - |
| Work-sharing or joint review | Decentralised proceduretarget 210 days | - |
| Device: exempt or self-declared |
| 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 | Integral drug-device combination authorised as a medicinetarget 210 days | Registration of a vaccine and lot releaseCOFEPRIS-04-030; COFEPRIS-05-031 |