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, 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. Italy: Centralised marketing authorisation, new active substance, 210 days. These are official targets, not actual review times.
| Pathway type | China | Italy |
|---|---|---|
| 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 | Centralised marketing authorisation, new active substancetarget 210 days · fee €865,200 Centralised authorisation of advanced therapy medicinal productstarget 210 days · fee €865,200 |
| 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 |
Centralised marketing authorisation, known active substance or new fixed combinationtarget 210 days · fee €690,700 Centralised hybrid applicationtarget 210 days · fee €426,100 |
| Generic application | Generic chemical drugChemical categories 3, 4 and 5.2 · target 200 days · fee CN¥502,000 · relies on EU, US, JP | Centralised generic applicationtarget 210 days · fee €177,900 |
| Biosimilar application | - | Centralised biosimilar applicationtarget 210 days · fee €732,400 |
| Well-established use | - | Centralised well-established use applicationtarget 210 days · fee €780,900 |
| Non-prescription application | Nonprescription (OTC) drug applicationtarget 200 days |
| Conditional or accelerated approval | Conditional marketing authorisationtarget 210 days |
| Approval under exceptional circumstances | - | Authorisation under exceptional circumstancestarget 210 days |
| Priority or accelerated review | Priority review and approvaltarget 130 days | Accelerated assessmenttarget 150 days |
| Intensive development support designation |
| Orphan or rare disease designation | - | Orphan designationtarget 90 days |
| Pediatric plan or incentive | - | Paediatric investigation plantarget 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, recognition or verification | - | Mutual recognition procedure with Italy as reference member statetarget 90 days · fee €16,309 Mutual recognition or decentralised procedure with Italy as concerned member statetarget 90 days · fee €81,546 Mutual recognition proceduretarget 90 days |
| Work-sharing or joint review | - | Decentralised procedure with Italy as reference member statetarget 120 days · fee €97,856 Decentralised proceduretarget 210 days |
| Device: exempt or self-declared | - |
| Device: premarket notification | - |
| Device: conformity assessment by a certification body | - |
| 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 | - |
| Other route | National classification after authorisation (class C(nn)) and reimbursement applicationtarget 180 days Integral drug-device combination authorised as a medicinetarget 210 days |