Routes of the same type are on the same row. Compare other markets.
12 pathway types exist in both markets: full application, new active substance, full or mixed application, known active substance, generic application, non-prescription application, conditional or accelerated approval, priority or accelerated review and more. The table lines up the routes of each type.
United States: New drug application (full, new active ingredient), 304 days. China: Marketing authorization for an innovative drug, 200 days. These are official targets, not actual review times.
| Pathway type | United States | China |
|---|---|---|
| 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 | Marketing authorization for an innovative drugChemical category 1; therapeutic biologic category 1 · target 200 days · fee CN¥593,900 Vaccine registrationPreventive biologic categories 1 to 3 · target 200 days |
| 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.
Improved new drug (known active substance)Chemical category 2; therapeutic biologic category 2 · target 200 days |
| Generic application | Abbreviated new drug application (generic)505(j) ANDA · target 304 days · fee $375,684 | Generic chemical drugChemical categories 3, 4 and 5.2 · target 200 days · fee CN¥502,000 · relies on EU, US, JP |
| Biosimilar application | Biosimilar application (351(k))351(k) BLA · target 304 days · fee $1,124,936 | - |
| Non-prescription application | Nonprescription (OTC) drug applicationtarget 200 days |
| Non-prescription monograph | Over-the-counter monograph orderOMOR · fee $614,608 | - |
| Conditional or accelerated approval |
| Priority or accelerated review | Priority reviewtarget 183 days | Priority review and approvaltarget 130 days |
| Intensive development support designation |
| Rolling or phased review | - |
| Orphan or rare disease designation | - |
| Pediatric plan or incentive | - |
| Emergency or temporary authorisation |
| Early or compassionate access | Hong Kong and Macao drugs and devices in the Greater Bay Areatarget 5 days · relies on HK, MO |
| Device: exempt or self-declared | - |
| Device: premarket notification | Premarket notification (510(k))510(k) · target 90 days · fee $28,653 |
| 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 | - |
| Device: registration or licence with the regulator | - | Class II device and IVD registrationtarget 60 days · fee CN¥210,900 Class III device and IVD registrationtarget 90 days · fee CN¥308,800 |
| Device: breakthrough or priority program |
| Device: humanitarian or limited population route | - |
| Other route |