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, conditional or accelerated approval, priority or accelerated review and more. The table lines up the routes of each type.
Italy: Centralised marketing authorisation, new active substance, 210 days. India: Permission to import or manufacture a new drug with a new molecule, 90 days. These are official targets, not actual review times.
| Pathway type | Italy | India |
|---|---|---|
| Full application, new active substance | Centralised marketing authorisation, new active substancetarget 210 days · fee €865,200 Centralised authorisation of advanced therapy medicinal productstarget 210 days · fee €865,200 | Permission to import or manufacture a new drug with a new moleculeForm CT-18 / CT-21 · target 90 days · fee ₹500,000 Vaccine approval and lot releasetarget 90 days |
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.
| Full or mixed application, known active substance | Centralised marketing authorisation, known active substance or new fixed combinationtarget 210 days · fee €690,700 Centralised hybrid applicationtarget 210 days · fee €426,100 | Permission for new claims of an approved new drugForm CT-18 / CT-21, Table 3 · target 90 days Permission for a fixed dose combinationForm CT-18 / CT-21 · target 90 days · fee ₹500,000 |
| Generic application | Centralised generic applicationtarget 210 days · fee €177,900 | Permission for a new drug already approved in India (subsequent applicant)Form CT-18 / CT-21, Table 2 · target 90 days · fee ₹200,000 State manufacturing licence for drugs that are not new drugsForm 24 / Form 25 · fee ₹6,000 |
| Biosimilar application | Centralised biosimilar applicationtarget 210 days · fee €732,400 | Similar biologic (biosimilar) approvaltarget 90 days |
| Well-established use | Centralised well-established use applicationtarget 210 days · fee €780,900 | - |
| Non-prescription application | - |
| Conditional or accelerated approval | Conditional marketing authorisationtarget 210 days | Accelerated approvalSecond Schedule para 1(2)(ii)(A) · target 90 days |
| Approval under exceptional circumstances | Authorisation under exceptional circumstancestarget 210 days | - |
| Priority or accelerated review | Accelerated assessmenttarget 150 days | Expedited reviewSecond Schedule para 1(2)(ii)(B) |
| Intensive development support designation | - |
| Orphan or rare disease designation | Orphan designationtarget 90 days | Orphan drug provisionsRule 2(1)(x) · target 90 days |
| Pediatric plan or incentive | Paediatric investigation plantarget 60 days | - |
| Emergency or temporary authorisation | - |
| Early or compassionate access | Import of an unapproved new drug by a government hospitalForm CT-24 / CT-25 · fee ₹10,000 Manufacture of an unapproved new drug under trial for individual patientsForm CT-26 / CT-27 · fee ₹5,000 |
| Reliance route, abridged review | - | Local clinical trial waiver for drugs approved in specified countriesRule 101 · target 90 days · relies on US, GB, JP, AU, CA, EU |
| 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: premarket approval by the regulator | - | Permission for a medical device without a predicateForm MD-26 / MD-27 · fee ₹100,000 · relies on GB, US, AU, CA, JP, EU Permission for a new in vitro diagnostic deviceForm MD-28 / MD-29 · fee ₹25,000 |
| Device: conformity assessment by a certification body | Manufacturing licence for Class A and B devicesForm MD-3 / MD-5 |
| Device: registration or licence with the regulator | Import licence for medical devices and IVDsForm MD-14 / MD-15 · relies on AU, CA, JP, EU, US, GB Manufacturing licence for Class C and D devicesForm MD-7 / MD-9 · target 45 days |
| Other route | National classification after authorisation (class C(nn)) and reimbursement applicationtarget 180 days Integral drug-device combination authorised as a medicinetarget 210 days | Registration certificate and import licence for imported drugsForm 40 / Form 41, Form 8 / Form 10 · fee ₹10,000 |