v4.0
eCTD v4.0 worldwide
Every market with an official eCTD v4.0 document, linked to its country page and current document status.
eCTD v4.0 worldwide
Australia · eCTD v4.0 TGA · Therapeutic Goods Administration · In forceAU
Brazil · eCTD v4.0 ANVISA (Brazilian Health Regulatory Agency) · In forceBR
Canada · eCTD v4.0 Health Canada · In forceCA
China · eCTD v4.0 Center for Drug Evaluation (CDE), NMPA · In forceCN
European Union · eCTD v4.0 EC · EMA (European Commission & European Medicines Agency) · In forceEU
Japan · eCTD v4.0 MHLW · PMDA (Pharmaceuticals and Medical Devices Agency) · In forceJP
United States · eCTD v4.0 FDA · U.S. Food and Drug Administration · In forceUS
Gulf Cooperation Council (GCC) · eCTD v4.0 SFDA (Saudi) leads the GCC Module 1 Specification · In forceGCC
Republic of Korea · eCTD v4.0 Ministry of Food and Drug Safety (MFDS, formerly KFDA) · In forceKR
Singapore · eCTD v4.0 HSA · Health Sciences Authority · In forceSG
South Africa · eCTD v4.0 SAHPRA · South African Health Products Regulatory Authority · In forceZA
Switzerland · eCTD v4.0 Swissmedic · In forceCH
Jordan · eCTD v4.0 JFDA (Jordan Food and Drug Administration) · In forceJO