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: registration or licence with the regulator and more. The table lines up the routes of each type.
United Kingdom: National assessment for innovative medicines, 150 days. These are official targets, not actual review times.
| Pathway type | United Kingdom | Mexico |
|---|---|---|
| Full application, new active substance | National assessment for innovative medicinesRegulation 50 · target 150 days · fee £124,194 Marketing authorisation for advanced therapiestarget 150 days | 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 | Generic medicine applicationRegulation 51B · target 210 days · fee £12,589 | Registration of a generic medicineCOFEPRIS-04-030 · fee MX$111,012 |
| Biosimilar application | Biosimilar applicationRegulation 53B · target 150 days | Registration of a biocomparable (biosimilar) medicineCOFEPRIS-04-030 |
| Well-established use | Well-established use applicationRegulation 54 · target 210 days · fee £34,335 | - |
| Non-prescription application | Reclassification to pharmacy or general saletarget 120 days |
| Traditional or herbal registration | - | Registration of herbal, homeopathic and vitamin medicinesCOFEPRIS-04-030 · fee MX$26,398 |
| Conditional or accelerated approval | - |
| Approval under exceptional circumstances | - |
| Intensive development support designation | - |
| Rolling or phased review | Rolling reviewtarget 100 days | - |
| Orphan or rare disease designation | Orphan designationfee £124,194 | - |
| Early or compassionate access | Early Access to Medicines Scheme (EAMS)target 75 days · fee £31,214 | - |
| 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 | International Recognition Procedure, Recognition Atarget 60 days · fee £24,688 · relies on US, EU, JP, CA, AU, CH, SG International Recognition Procedure, Recognition Btarget 110 days · fee £83,580 · relies on US, EU, JP, CA, AU, CH, SG CE marked devices in Great Britainrelies on EU | - |
| Work-sharing or joint review | Project Orbis (cancer medicines)target 150 days · relies on US | - |
| 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 | Registration of a vaccine and lot releaseCOFEPRIS-04-030; COFEPRIS-05-031 |