v3.2.2
eCTD v3.2.2 worldwide
Every market with an official eCTD v3.2.2 document, linked to its country page and current document status.
eCTD v3.2.2 worldwide
Australia · eCTD v3.2.2 · AU M1 TGA · Therapeutic Goods Administration · In forceAU
Canada · eCTD v3.2.2 Health Canada · In forceCA
China · eCTD v3.2.2 Center for Drug Evaluation (CDE), NMPA · In forceCN
European Union · eCTD v3.2.2 · EU M1 EC · EMA (European Commission & European Medicines Agency) · In forceEU
Japan · eCTD v3.2.2 MHLW · PMDA (Pharmaceuticals and Medical Devices Agency) · In forceJP
United States · eCTD v3.2.2 FDA · U.S. Food and Drug Administration · In forceUS
Egypt · eCTD v3.2.2 · EG M1 Egyptian Drug Authority (EDA) · In forceEG
Gulf Cooperation Council (GCC) · eCTD v3.2.2 · GCC M1 SFDA (Saudi) leads the GCC Module 1 Specification · In forceGCC
Republic of Korea · eCTD v3.2.2 Ministry of Food and Drug Safety (MFDS, formerly KFDA) · In forceKR
Singapore · eCTD v3.2.2 · SG M1 HSA · Health Sciences Authority · In forceSG
South Africa · eCTD v3.2.2 · ZA M1 SAHPRA · South African Health Products Regulatory Authority · In forceZA
Switzerland · eCTD v3.2.2 Swissmedic · In forceCH
Taiwan, China · eCTD v3.2.2 · TW M1 Taiwan Food and Drug Administration (TFDA) · In forceTW
WHO Prequalification · eCTD v3.2.2 · WHO M1 WHO Prequalification Unit (PQT) · In forceWHO
Bosnia and Herzegovina · eCTD v3.2.2 · EU M1 Medicines Agency of BiH (ALMBIH) · In forceBA
Jordan · eCTD v3.2.2 JFDA (Jordan Food and Drug Administration) · In forceJO
Tunisia · eCTD v3.2.2 · TN M1 National Agency for Medicines and Health Products (ANMPS) · In forceTN
Ukraine · eCTD v3.2.2 · UA M1 State Expert Center of the Ministry of Health (DEC) · In forceUA