Routes of the same type are on the same row. Compare other markets.
13 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, conditional or accelerated approval and more. The table lines up the routes of each type.
United States: New drug application (full, new active ingredient), 304 days. Japan: Approval of a drug with a new active ingredient, 365 days. These are official targets, not actual review times.
| Pathway type | United States | Japan |
|---|---|---|
| Full application, new active substance | New drug application (full, new active ingredient)505(b)(1) · target 304 days · fee $4,600,753 Biologics license application (351(a))351(a) BLA · target 304 days · fee $4,600,753 | 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 |
| 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.
Approval of a known active ingredient with a new route, indication, dosage form or doseArticle 14 approval or partial change approval · fee ¥36,538,400 |
| Generic application | Abbreviated new drug application (generic)505(j) ANDA · target 304 days · fee $375,684 | Approval of a generic prescription drugArticle 14 approval · target 304 days · fee ¥649,100 |
| Biosimilar application | Biosimilar application (351(k))351(k) BLA · target 304 days · fee $1,124,936 | Approval of a biosimilarApplication category (7) |
| 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 |
| Non-prescription monograph | Over-the-counter monograph orderOMOR · fee $614,608 | - |
| 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 reviewtarget 183 days | 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 |
| Rolling or phased review | - |
| Orphan or rare disease designation | Orphan designationArticle 77-2(1) · fee ¥30,618,800 |
| Pediatric plan or incentive | - |
| 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 |
| Early or compassionate access | - |
| 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 |
| Device: exempt or self-declared | - |
| Device: premarket notification | Premarket notification (510(k))510(k) · target 90 days · fee $28,653 | Notification of a Class I device or a low-risk IVDArticle 23-2-12 |
| Device: new low or moderate risk device | De Novo classification request513(f)(2) · target 150 days · fee $191,020 | - |
| Device: premarket approval by the regulator | Premarket approval (PMA)PMA · target 180 days · fee $636,732 | 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: breakthrough or priority program | - |
| Device: humanitarian or limited population route | - |
| 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) |