Routes of the same type are on the same row. Compare other markets.
11 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.
Japan: Approval of a drug with a new active ingredient, 365 days. Switzerland: Ordinary authorization of a medicine with a new active substance, 330 days. These are official targets, not actual review times.
| Pathway type | Japan | Switzerland |
|---|---|---|
| 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 | Ordinary authorization of a medicine with a new active substanceArt. 11 HMG · target 330 days · fee CHF 80,000 |
| Full or mixed application, known active substance | 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 |
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 | Simplified authorization of a generic (known active substance without innovation)Art. 14 Abs. 1 Bst. a HMG; Art. 12-14 VAZV · target 330 days · fee CHF 15,000 |
| Biosimilar application | Approval of a biosimilarApplication category (7) | Authorization of a biosimilarArt. 4 Abs. 1 Bst. anovies HMG · target 330 days · fee CHF 50,000 · relies on EU, US |
| Well-established use | - | Simplified authorization for active substances used for ten years in the EU or EFTAArt. 14 Abs. 1 Bst. abis HMG; Art. 17a-17b VAZV · target 330 days · relies on EU Simplified authorization for long-used non-prescription medicinesArt. 14 Abs. 1 Bst. ater HMG; Art. 17c VAZV · target 330 days · relies on EU |
| 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 status: dispensing category and switchArt. 23-23a HMG; Art. 40-44 VAM · target 270 days |
| Traditional or herbal registration | - | Simplified authorization of herbal and complementary medicinesArt. 14 Abs. 1 Bst. b und cbis HMG · target 120 days · fee CHF 3,000 |
| 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 | Temporary authorization (incomplete data)Art. 9a HMG; Art. 18-22 VAZV · target 140 days · fee CHF 80,000 |
| Priority or accelerated review | Priority reviewArticle 14(11), 23-2-5(11) and 23-25 · target 274 days | Fast-track authorization procedureArt. 7 VAM · target 140 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 | Orphan drug status (important medicine for a rare disease)Art. 4 Abs. 1 Bst. adecies HMG; Art. 4-5 VAZV · target 210 days · relies on EU, US |
| Pediatric plan or incentive | - | Pediatric investigation plan and pediatric incentivesArt. 54a HMG; Art. 5 VAM |
| 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 | - | Exceptional authorization of a device without conformity assessmentArt. 22 MepV; Art. 18 IvDV |
| 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 | Authorization based on a foreign authorization (Article 13 procedure)Art. 13 HMG; Art. 16-20 VAM · target 195 days · fee CHF 15,000 · relies on EU, US, GB, CA, AU, JP, SG |
| 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 | Medical device conformity assessment and placing on the marketArt. 45-47 HMG; MepV · relies on EU In vitro diagnostic device conformity assessment and placing on the marketIvDV · relies on EU |
| Device: registration or licence with the regulator | - | Registration of device economic operators and productsArt. 47 HMG; Art. 17 and 55 MepV |
| 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) | Procedure with prior notification (20 percent shorter review for a double fee)Art. 7 GebV-Swissmedic · target 264 days Simplified authorization for a parallel importArt. 14 Abs. 2 und 3 HMG · target 330 days · fee CHF 4,000 |