OVERVIEW OF ACTD AND eCTD
1. ACTD – ASEAN COMMON TECHNICAL DOCUMENT
ACTD is the common format for submission of dossier in ASEAN countries. ASEAN means Association of South East Asian Nations – 10 countries: Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam.
ICH CTD is for US, EU, Japan (developed countries). ACTD is for ASEAN countries (semi-regulated markets). The purpose is same – to harmonize and avoid reformatting for each ASEAN country.
ACTD is organized into 4 Parts, not 5 Modules like ICH CTD.
ICH CTD = 5 Modules (Module 1 region specific, Module 2-5 common)
ACTD = 4 Parts (Part I to Part IV)
Organization of ACTD:
This is similar to Module 1 of CTD. Region specific.
– Table of Contents
– Administrative data: Application form, Letter of authorization, Certifications (GMP, CPP, Patent)
– Product Information: Prescribing Information, Package Insert, Labeling, Mock-ups
This is similar to Module 2.3 + Module 3 of CTD.
– Part II S – Active Pharmaceutical Ingredient (Drug Substance): Same as 3.2.S – Nomenclature, Manufacture, Characterization, Control, Reference Standard, Container, Stability.
– Part II P – Finished Product (Drug Product): Same as 3.2.P – Description, Pharmaceutical Development, Manufacture, Control of Excipients, Control of Product, Reference Standard, Container, Stability.
Similar to Module 4 of CTD.
– Table of contents
– Non-clinical Overview
– Non-clinical Written and Tabulated Summaries: Pharmacology, Pharmacokinetics, Toxicology
– Non-clinical Study Reports
Similar to Module 5 of CTD.
– Table of contents
– Clinical Overview
– Clinical Summary: Biopharmaceutics, Clinical Pharmacology, Efficacy, Safety
– Clinical Study Reports
– List of Key Literature References
Part I (Admin) | Part II (Quality) | Part III (Non-clinical) | Part IV (Clinical)
| ICH CTD (US, EU, Japan) | ACTD (ASEAN) |
|---|---|
| Module 1 – Admin (Region specific) | Part I – Admin and Product Information |
| Module 2 – Summaries (QOS, Non-clinical, Clinical Overview) | Part II includes QOS inside Quality Part |
| Module 3 – Quality | Part II – Quality |
| Module 4 – Non-clinical | Part III – Non-clinical |
| Module 5 – Clinical | Part IV – Clinical |
Note: For generic products in ASEAN, we mainly submit Part I and Part II only. Part III and Part IV are not required if bioequivalence is shown, except for some countries.
2. eCTD – ELECTRONIC COMMON TECHNICAL DOCUMENT
eCTD is not a new dossier format. It is the electronic version of CTD. Same 5 modules, but submitted electronically with XML backbone.
In July 2003, CTD became mandatory paper format. Then from 2006 onwards, eCTD became mandatory for EU, US FDA, Japan PMDA.
Now US FDA accepts only eCTD. Paper NDA / ANDA is not accepted. For EU also eCTD is mandatory for all procedures – Centralized, DCP, MRP, National.
– To make electronic submission easy for review
– To manage life-cycle of dossier (initial, supplements, variations)
– To avoid bulky paper dossiers
– To enable good review practices with hyperlinks and bookmarks
Structure of eCTD:
eCTD has 5 modules same as CTD, but with additional technical features:
- XML Backbone: index.xml file is the backbone which links all documents. This is main difference from paper CTD.
- Folder Structure: Folders named m1, m2, m3, m4, m5 for each module.
- Life-cycle Management: Each document has operation attribute – New, Replace, Append, Delete. So agency can see what changed in variation.
- Envelope and Regional DTD: For Module 1 administrative info.
- PDF Requirement: All documents should be in searchable PDF, with proper bookmarks and hyperlinks.
index.xml (Backbone) -> m1 (Admin) -> m2 (Summaries) -> m3 (Quality) -> m4 (Non-clinical) -> m5 (Clinical) -> util folder
eCTD Life-cycle:
Sequence 0001: First response to deficiency / First supplement
Sequence 0002: Second response, etc.
Each sequence is a separate folder with new index.xml. Reviewer can see cumulative history.
Differences – Paper CTD vs eCTD:
| Paper CTD | eCTD |
|---|---|
| Bulky paper files, multiple copies | Electronic files in CD/DVD or ESG Gateway |
| No life-cycle, new full dossier for variation | Life-cycle managed via replace/append/delete |
| No hyperlinks | All cross-references hyperlinked |
| Review is difficult | Review is easy with navigation and bookmarks |
| Now obsolete | Mandatory in US, EU, Japan, Canada, Thailand etc. |
Software for eCTD:
For industries, eCTD compilation is done using software like:
- DocuBridge (by LORENZ) – Most used
- eCTD Manager (by EXTEDO)
- PHLEX, eCTD Xpress etc.
These software validate against ICH and regional DTDs and give final eCTD ready for submission.
Summary: ICH CTD = For regulated markets (US, EU, Japan) – 5 Modules. ACTD = For ASEAN semi-regulated – 4 Parts. eCTD = Electronic version of ICH CTD with XML backbone and life-cycle. Now eCTD is mandatory everywhere.
The information provided on this page is for educational and informational purposes only. It is not intended to provide regulatory, legal, or compliance advice.
Pharmaceutical regulations including FDA 21 CFR, EU GMP Annexes, ICH Guidelines, EDQM, WHO, and CDSCO requirements are subject to frequent updates and interpretation by regulatory authorities.
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About the Author
Mahummed Asif is a experienced pharmaceutical Quality Assurance professional and publisher of Pharmashare. He has worked with leading Pharmaceutical organizations and has developed extensive expertise in Quality Assurance, deviation management, investigations, CAPA, QMS, Product Life Cycle Management, change control, risk management, validation, product complaints, product recalls, and regulatory compliance. He is passionate about sharing practical pharmaceutical knowledge with professionals, students, and quality practitioners across the industry.