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, non-prescription application, conditional or accelerated approval, intensive development support designation and more. The table lines up the routes of each type.
United Kingdom: National assessment for innovative medicines, 150 days. China: Marketing authorization for an innovative drug, 200 days. These are official targets, not actual review times.
| Pathway type | United Kingdom | China |
|---|---|---|
| Full application, new active substance | National assessment for innovative medicinesRegulation 50 · target 150 days · fee £124,194 Marketing authorisation for advanced therapiestarget 150 days | 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 | Generic medicine applicationRegulation 51B · target 210 days · fee £12,589 | Generic chemical drugChemical categories 3, 4 and 5.2 · target 200 days · fee CN¥502,000 · relies on EU, US, JP |
| Biosimilar application | Biosimilar applicationRegulation 53B · target 150 days | - |
| Well-established use | Well-established use applicationRegulation 54 · target 210 days · fee £34,335 | - |
| Non-prescription application | Reclassification to pharmacy or general saletarget 120 days | Nonprescription (OTC) drug applicationtarget 200 days |
| Conditional or accelerated approval |
| Approval under exceptional circumstances | - |
| Priority or accelerated review | - | Priority review and approvaltarget 130 days |
| Intensive development support designation |
| Rolling or phased review | Rolling reviewtarget 100 days | - |
| Orphan or rare disease designation | Orphan designationfee £124,194 | - |
| Emergency or temporary authorisation | - |
| Early or compassionate access | Early Access to Medicines Scheme (EAMS)target 75 days · fee £31,214 | Hong Kong and Macao drugs and devices in the Greater Bay Areatarget 5 days · relies on HK, MO |
| Reliance route, recognition or verification | International Recognition Procedure, Recognition Atarget 60 days · fee £24,688 · relies on US, EU, JP, CA, AU, CH, SG International Recognition Procedure, Recognition Btarget 110 days · fee £83,580 · relies on US, EU, JP, CA, AU, CH, SG CE marked devices in Great Britainrelies on EU | - |
| Work-sharing or joint review | Project Orbis (cancer medicines)target 150 days · relies on US | - |
| 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 |