Regulatory Authorities
The authority directory lists all competent authorities and their operational parameters including preferred submission format, portal URL, timezone, and associated markets. Authority records drive the publishing and dispatch configuration for each application.
| ID | Short Name | Full Name | Region | Format | Timezone | Portal |
|---|---|---|---|---|---|---|
| AUTH-001 | FDA | Food and Drug Administration | North America | eCTD | America/New_York | FDA Portal ↗ |
| AUTH-002 | EMA | European Medicines Agency | Europe | eCTD | Europe/Amsterdam | EMA Portal ↗ |
| AUTH-003 | PMDA | Pharmaceuticals and Medical Devices Agency | Asia Pacific | eCTD | Asia/Tokyo | PMDA Portal ↗ |
| AUTH-004 | NMPA | National Medical Products Administration | Asia Pacific | CTD | Asia/Shanghai | NMPA Portal ↗ |
| AUTH-005 | ANVISA | Agência Nacional de Vigilância Sanitária | Latin America | CTD | America/Sao_Paulo | ANVISA Portal ↗ |
| AUTH-006 | HC | Health Canada | North America | eCTD | America/Toronto | HC Portal ↗ |
| AUTH-007 | TGA | Therapeutic Goods Administration | Asia Pacific | eCTD | Australia/Sydney | TGA Portal ↗ |
| AUTH-008 | MHRA | Medicines and Healthcare products Regulatory Agency | Europe | eCTD | Europe/London | MHRA Portal ↗ |
| AUTH-009 | SwissMedic | Swissmedic | Europe | eCTD | Europe/Zurich | SwissMedic Portal ↗ |
| AUTH-010 | MFDS | Ministry of Food and Drug Safety | Asia Pacific | eCTD | Asia/Seoul | MFDS Portal ↗ |
| AUTH-011 | TFDA | Taiwan Food and Drug Administration | Asia Pacific | CTD | Asia/Taipei | TFDA Portal ↗ |
| AUTH-012 | HSA | Health Sciences Authority | Asia Pacific | eCTD | Asia/Singapore | HSA Portal ↗ |
| AUTH-013 | CDSCO | Central Drugs Standard Control Organisation | Asia Pacific | CTD | Asia/Kolkata | CDSCO Portal ↗ |
| AUTH-014 | COFEPRIS | COFEPRIS | Latin America | CTD | America/Mexico_City | COFEPRIS Portal ↗ |
| AUTH-015 | ANMAT | ANMAT | Latin America | CTD | America/Buenos_Aires | ANMAT Portal ↗ |
| AUTH-016 | TITCK | Turkish Medicines and Medical Devices Agency | Middle East | CTD | Europe/Istanbul | TITCK Portal ↗ |
| AUTH-017 | SFDA | Saudi Food and Drug Authority | Middle East | CTD | Asia/Riyadh | SFDA Portal ↗ |
| AUTH-018 | SAHPRA | South African Health Products Regulatory Authority | Africa | CTD | Africa/Johannesburg | SAHPRA Portal ↗ |
| AUTH-019 | Roszdravnadzor | Ministry of Health of Russia | Europe | CTD | Europe/Moscow | Roszdravnadzor Portal ↗ |
| AUTH-020 | MOH-IL | Israel Ministry of Health | Middle East | CTD | Asia/Jerusalem | MOH-IL Portal ↗ |