Routes of the same type are on the same row. Compare other markets.
10 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.
China: Marketing authorization for an innovative drug, 200 days. These are official targets, not actual review times.
| Pathway type | China | Brazil |
|---|---|---|
| Full application, new active substance | 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 | Registration of a new medicinefee R$157,416 |
| 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 |
Registration of an innovative medicinefee R$37,231 |
| Generic application | Generic chemical drugChemical categories 3, 4 and 5.2 · target 200 days · fee CN¥502,000 · relies on EU, US, JP | Registration of a generic medicinefee R$11,714 Registration of a similar medicinefee R$41,000 |
| Biosimilar application | - |
| Non-prescription application | Nonprescription (OTC) drug applicationtarget 200 days |
| Non-prescription monograph | - |
| Conditional or accelerated approval |
| Priority or accelerated review | Priority review and approvaltarget 130 days |
| Intensive development support designation | - |
| Orphan or rare disease designation | - | Special procedure for new medicines for rare diseasestarget 60 days |
| 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 |
| Reliance route, abridged review | - | Optimized analysis using an equivalent foreign authorityrelies on EU, CA, WHO, CH, GB, US, AU, JP Optimized analysis for class III and IV devices approved abroadrelies on AU, CA, US, JP |
| Device: premarket notification | Notification of a class I or II medical devicetarget 30 days |
| 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 | Registration of a class III or IV medical devicetarget 320 days · fee R$39,048 Registration of a class III or IV in vitro diagnostic devicetarget 365 days · fee R$15,619 Software as a medical device (notification or registration)target 250 days |
| Device: breakthrough or priority program | - |
| Other route | Good manufacturing practice certification (CBPF)target 365 days |