Global Directory
A comprehensive directory of regulatory authorities worldwide. Explore the agencies responsible for drug registration in ICH regions, ASEAN countries, and emerging markets.
Understanding eCTD vs ACTD
The difference between the two major dossier formats used globally for drug registration.
eCTD
Electronic Common Technical Document
- Module 1: Regional Administrative Information
- Module 2: CTD Summaries (QOS, Non-clinical & Clinical Overview)
- Module 3: Quality Data
- Module 4: Nonclinical Study Reports
- Module 5: Clinical Study Reports
Used in ICH regions including USA, Europe, Japan, Canada, Australia, Switzerland, and the United Kingdom.
ACTD
ASEAN Common Technical Document
- Part I: Table of Contents & Administrative Data
- Part II: Quality Document (equivalent to eCTD Module 3)
- Part III: Nonclinical Document (equivalent to eCTD Module 4)
- Part IV: Clinical Document (equivalent to eCTD Module 5)
Used in ASEAN regions including Singapore, Malaysia, Thailand, Philippines, Vietnam, and Indonesia.
Section 1: ICH Regions & Western Markets
These countries follow the eCTD format with 5 Modules, as defined by the International Council for Harmonisation (ICH).
USA
US FDA
Food and Drug Administration
Europe
EMA
European Medicines Agency
Japan
PMDA
Pharmaceuticals and Medical Devices Agency
United Kingdom
MHRA
Medicines and Healthcare products Regulatory Agency
Canada
Health Canada
Health Canada
Australia
TGA
Therapeutic Goods Administration
Switzerland
Swissmedic
Swissmedic
Section 2: ASEAN Region
These countries follow the ACTD format with 4 Parts, as adopted by the Association of Southeast Asian Nations (ASEAN).
Singapore
HSA
Health Sciences Authority
Malaysia
NPRA
National Pharmaceutical Regulatory Agency
Thailand
Thai FDA
Thai FDA
Philippines
FDA Philippines
FDA Philippines
Vietnam
DAV
Drug Administration of Vietnam
Indonesia
BPOM
National Agency of Drug and Food Control
Section 3: Emerging Markets & ROW
These countries have their own unique submission formats. Each market has specific requirements that differ from the standard eCTD or ACTD.
India
CDSCO
Central Drugs Standard Control Organization
China
NMPA
National Medical Products Administration
Brazil
ANVISA
National Health Surveillance Agency
South Africa
SAHPRA
SAHPRA
Saudi Arabia (GCC)
SFDA
SFDA
Quick Reference Summary
7
ICH Countries
eCTD - 5 Modules
6
ASEAN Countries
ACTD - 4 Parts
5
Emerging Markets
Country-Specific Formats
Explore Dossier Formats in Detail
Now that you know which format each country uses, dive into the Dossier Masterclass to learn the structure of each eCTD module in detail.