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, reliance route, abridged review and more. The table lines up the routes of each type.
Japan: Approval of a drug with a new active ingredient, 365 days. These are official targets, not actual review times.
| Pathway type | Japan | Mexico |
|---|---|---|
| Full application, new active substance | Approval of a drug with a new active ingredientArticle 14 approval · target 365 days · fee ¥36,538,400 Approval of a regenerative medical product (cell or gene therapy)Article 23-25 · target 365 days · fee ¥18,803,400 | 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 | Approval of a generic prescription drugArticle 14 approval · target 304 days · fee ¥649,100 | Registration of a generic medicineCOFEPRIS-04-030 · fee MX$111,012 |
| Biosimilar application | Approval of a biosimilarApplication category (7) | Registration of a biocomparable (biosimilar) medicineCOFEPRIS-04-030 |
| Non-prescription application | Approval of a non-prescription drug (including switch OTC)OTC application categories (1) to (8) · target 365 days · fee ¥1,627,300 |
| Traditional or herbal registration | - | Registration of herbal, homeopathic and vitamin medicinesCOFEPRIS-04-030 · fee MX$26,398 |
| Conditional or accelerated approval | Conditional approvalArticle 14-2-2 and 23-2-6-2 Conditional and time-limited approval of a regenerative medical productArticle 23-26 · fee ¥9,411,700 | - |
| Priority or accelerated review | Priority reviewArticle 14(11), 23-2-5(11) and 23-25 · target 274 days | - |
| Intensive development support designation | Pioneering product designation (SAKIGAKE)Article 77-2(2) · target 183 days | - |
| Orphan or rare disease designation | Orphan designationArticle 77-2(1) · fee ¥30,618,800 | - |
| Emergency or temporary authorisation | Special approval for emergencies (based on foreign approval)Article 14-3 · relies on US, GB, CA, DE, FR Emergency approval (time-limited)Article 14-2-2-2 and 23-26-2 | - |
| Reliance route, abridged review | Fast priority review of a product already sold abroad during a supply shortageArticle 14(9) and 23-2-5(9) · relies on US, GB, CA, DE, FR | 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 | Notification of a Class I device or a low-risk IVDArticle 23-2-12 | - |
| Device: premarket approval by the regulator | Approval of a new medical deviceArticle 23-2-5 · target 426 days · fee ¥16,431,300 Approval of an improved medical deviceArticle 23-2-5 · target 304 days · fee ¥9,381,400 Approval of a generic (equivalent) medical deviceArticle 23-2-5 · target 122 days · fee ¥2,244,900 Approval of an in vitro diagnosticArticle 23-2-5 · target 213 days | - |
| Device: conformity assessment by a certification body | Third-party certification by a registered certification bodyArticle 23-2-23 | - |
| 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 | Approval held by a foreign manufacturer through a designated marketing authorization holderArticles 19-2, 23-2-17 and 23-37 Specific-use product designationArticle 77-2(3) | Registration of a vaccine and lot releaseCOFEPRIS-04-030; COFEPRIS-05-031 |