Routes of the same type are on the same row. Compare other markets.
9 pathway types exist in both markets: full application, new active substance, full or mixed application, known active substance, generic application, biosimilar application, conditional or accelerated approval, priority or accelerated review and more. The table lines up the routes of each type.
South Korea: New drug item permit, 70 days. Switzerland: Ordinary authorization of a medicine with a new active substance, 330 days. These are official targets, not actual review times.
| Pathway type | South Korea | Switzerland |
|---|---|---|
| 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 | 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 |
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.
Simplified authorization of a known active substance with innovationArt. 14 Abs. 1 Bst. a HMG; Art. 12-14 VAZV · target 330 days · fee CHF 30,000 |
| Generic application | Generic drug item permit (bioequivalence)target 55 days | 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 | Biosimilar item permittarget 115 days · fee ₩310,000,000 | 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 | - | Non-prescription status: dispensing category and switchArt. 23-23a HMG; Art. 40-44 VAM · target 270 days |
| Non-prescription monograph | - |
| 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 | Temporary authorization (incomplete data)Art. 9a HMG; Art. 18-22 VAZV · target 140 days · fee CHF 80,000 |
| Priority or accelerated review | Priority review designation (GIFT)target 90 days | Fast-track authorization procedureArt. 7 VAM · target 140 days |
| Orphan or rare disease designation | 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 |
| Early or compassionate access | - | Exceptional authorization of a device without conformity assessmentArt. 22 MepV; Art. 18 IvDV |
| Reliance route, abridged review | - | 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 | 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 | 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 |
| Device: breakthrough or priority program | - |
| Other route | 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 |