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, reliance route, abridged review, device: registration or licence with the regulator and more. The table lines up the routes of each type.
Taiwan: New indication or new dosage change, 180 days. These are official targets, not actual review times.
| Pathway type | Mexico | Taiwan |
|---|---|---|
| Full application, new active substance | Registration of a medicine with a new moleculeCOFEPRIS-04-030 · fee MX$198,496 Registration of an innovative biotechnology medicineCOFEPRIS-04-030 | New drug registration, new active substancetarget 360 days · fee NT$1,500,000 Biological product registration (recombinant products, vaccines, plasma products, allergens)target 360 days · fee NT$1,500,000 |
| 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.
New drug registration, known ingredient (new combination, route, dosage form, dose or strength)target 300 days · fee NT$500,000 New indication or new dosage changetarget 180 days |
| Generic application | Registration of a generic medicineCOFEPRIS-04-030 · fee MX$111,012 | Generic drug registrationtarget 210 days · fee NT$140,000 |
| Biosimilar application | Registration of a biocomparable (biosimilar) medicineCOFEPRIS-04-030 | Biosimilar registrationfee NT$1,500,000 |
| 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 | - | Conditional permit for regenerative medicinal productstarget 120 days · fee NT$1,500,000 New drug accelerated approvaltarget 240 days |
| Priority or accelerated review | - | New drug priority reviewtarget 240 days Device priority reviewfee NT$180,000 |
| Intensive development support designation | - | Breakthrough therapy designationtarget 240 days |
| Orphan or rare disease designation | - | Designation for drugs for pediatric or rare severe diseasestarget 240 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 | New drug streamlined review (reliance on US, EU and Japan approvals)target 180 days · relies on US, EU, JP |
| Device: exempt or self-declared | - |
| Device: premarket notification | - | Class 1 device listingfee NT$10,000 |
| Device: new low or moderate risk device | - | License for a device with no similar product in Taiwantarget 220 days · fee NT$130,000 License for a world-first devicetarget 365 days · fee NT$250,000 |
| Device: premarket approval by the regulator | - | Class 3 device licensetarget 200 days · fee NT$100,000 |
| 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 | Class 1 device licensetarget 80 days · fee NT$15,000 Class 2 device licensetarget 140 days · fee NT$58,000 · relies on US, EU In vitro diagnostic device license (Class 2 and Class 3)target 150 days · fee NT$100,000 |
| Other route | Registration of a vaccine and lot releaseCOFEPRIS-04-030; COFEPRIS-05-031 |