Routes of the same type are on the same row. Compare other markets.
5 pathway types exist in both markets: full application, new active substance, full or mixed application, known active substance, generic application, biosimilar application, other route. The table lines up the routes of each type.
South Korea: New drug item permit, 70 days. These are official targets, not actual review times.
| Pathway type | South Korea | Mexico |
|---|---|---|
| Full application, new active substance | New drug item permittarget 70 days · fee ₩410,000,000 Item permit for biological products and vaccinestarget 115 days · fee ₩8,031,000 Item permit for advanced biological products (cell and gene therapy)target 70 days · fee ₩205,000,000 | 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 |
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 drug item permit (bioequivalence)target 55 days | Registration of a generic medicineCOFEPRIS-04-030 · fee MX$111,012 |
| Biosimilar application | Biosimilar item permittarget 115 days · fee ₩310,000,000 | Registration of a biocomparable (biosimilar) medicineCOFEPRIS-04-030 |
| Non-prescription application | - |
| Non-prescription monograph | - |
| 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 review designation (GIFT)target 90 days | - |
| Orphan or rare disease designation | - |
| 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 | Class 1 medical device notificationtarget 5 days In vitro diagnostic device notification (Class 1)target 5 days · fee ₩85,000 Digital medical device notification (Class 1)target 5 days | - |
| Device: premarket approval by the regulator | Medical device permit (Classes 2 to 4)target 80 days · fee ₩98,430,000 In vitro diagnostic device permit (Classes 2 to 4)target 80 days · fee ₩1,495,000 Digital medical device permit or certification (including software)target 80 days · fee ₩1,495,000 | - |
| Device: conformity assessment by a certification body | Class 2 medical device certificationtarget 5 days · fee ₩130,000 In vitro diagnostic device certification (Class 2)target 5 days · fee ₩130,000 | - |
| 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 | - |
| Other route | Registration of a vaccine and lot releaseCOFEPRIS-04-030; COFEPRIS-05-031 |