Understanding CTD eCTD and ACTD Key Differences in Pharmaceutical Dossier Submissions.pdf

Let’s be honest: pharma submissions can feel like a bureaucratic endurance test. Mountains of data. Endless formatting rules. And then, just to make life harder, you’re hit with three acronyms—CTD, eCTD, ACTD, all promising to be the “right” way to submit.
Here’s the truth: choosing the right dossier format isn’t optional. It can mean the difference between a fast-track review and months of regulatory limbo. Most professionals stumble because they treat CTD, eCTD, and ACTD as interchangeable. They’re not.
In this guide, I’ll strip away the jargon and give you a simple playbook: what each format is, where it works, and how to use it strategically. Think of it as your shortcut to one of pharma’s most frustrating bottlenecks.

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Understanding CTD, eCTD, & ACTD: Key
Differences in Pharma Dossier Submissions
Let’s be honest: pharma submissions can feel like a bureaucratic endurance test. Mountains
of data. Endless formatting rules. And then, just to make life harder, you’re hit with three
acronyms—CTD, eCTD, ACTD, all promising to be the “right” way to submit.
Here’s the truth: choosing the right dossier format isn’t optional. It can mean the difference
between a fast-track review and months of regulatory limbo. Most professionals stumble
because they treat CTD, eCTD, and ACTD as interchangeable. They’re not.
In this guide, I’ll strip away the jargon and give you a simple playbook: what each format is,
where it works, and how to use it strategically. Think of it as your shortcut to one of pharma’s
most frustrating bottlenecks.
What Is CTD?
The Common Technical Document (CTD) is a standardized drug-submission format created
under the International Council for Harmonisation (ICH), harmonizing regulatory
requirements across the EU, US, Japan, and beyond.
Importance of CTD
 It replaced disparate regional formats with a single, logical structure.
 It simplifies dossier approval, reduces duplication, and improves global submission
efficiency.
5 Modules of CTD
Module 1 – Administrative & Prescribing Info: Tailored per region (forms, labels, patient
info) and not harmonized.
Module 2 – Summaries & Overviews: Presents high-level summaries of Modules 3–5,
including:
 Table of Contents & Introduction
 Quality Overview (QOS)
 Non-clinical Overview & Summary
 Clinical Overview & Summary.
Module 3 – Quality: Contains detailed chemistry, manufacturing, controls, and stability data.
Module 4 – Non-Clinical Data: Includes pharmacology, pharmacokinetics, and toxicology
study reports.
Module 5 – Clinical Data: Covers clinical study reports: safety, efficacy, trial summaries,
and literature references.

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Benefits of CTD
 Harmonizes submission formats globally—no reinventing the wheel every time.
 Eases cross-border reviews and speeds regulator understanding.
 Cuts drafting time and eliminates redundant content.
What About eCTD?
The eCTD (electronic Common Technical Document) is the digital evolution of the CTD,
built on the same five-module structure but with an XML backbone enabling smarter
submission.
It was formalized by the ICH in 2002–2008 and is now the required format in regions like the
FDA and EMA.
Key Enhancements Over CTD
 XML Backbone for Metadata and Structure: It replaces static tables of contents
with a dynamic XML framework that maps files, tracks metadata, and ensures file
integrity via MD5 checksums
 Version Control & Incremental Updates: Submission sequences are organized
clearly. Only new or amended documents need inclusion—old files remain intact and
traceable.
 Mandatory in Key Markets: The FDA and EMA now require eCTD submissions for
NDAs, ANDAs, BLAs, and other drug applications. It’s also accepted broadly in
regions like Canada, Japan, and GCC countries.
Advantages of eCTD
 Streamlined Submissions: Sponsors can clone, update, and re-use content across
versions effortlessly
 Reviewer-Friendly Navigation: Regulators can search, hyperlink, and traverse
documents quickly, speeding up review cycles.
 Audit-Ready and Lifecycle-Managed: Automated validation, checksum monitoring,
and submission sequencing ensure documents remain tamper-proof and traceable over
time.
What Is ACTD? (ASEAN)
The ASEAN Common Technical Dossier (ACTD) is a regional CTD variant built for
Southeast Asia. It was created to harmonize dossier requirements across ASEAN regulators.
ACTD is simpler than the ICH CTD and designed for resource-sensitive settings. It uses four
parts, not five. That makes local submissions easier to assemble and review.
Key structural differences:
 Four parts: administrative data and product info, quality, non-clinical, and clinical.

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 No Module 2 summary like ICH CTD; summary elements are embedded in each
part.
 No XML backbone — navigation is table-of-contents based, not XML driven.
When to use ACTD: for marketing applications across ASEAN countries, especially where a
lighter, region-specific dossier speeds review. It’s often used as a first step before migrating
to CTD/eCTD for global filings.
CTD vs. eCTD vs. ACTD: Quick Comparison Table
Aspect
CTD (Common
Technical Document)
eCTD (Electronic
CTD)
ACTD (ASEAN CTD)
Origin/Scope
ICH standard to
harmonize dossiers across
major regulators.
Digital evolution of CTD
using the same five-
module logic.
Regional dossier for
ASEAN members, built
to harmonize local
submissions.
Structure
Five modules: M1
(regional) + M2–M5
(summaries, quality, non-
clinical, clinical).
Same five modules, but
organized and referenced
via XML backbone.
Four parts: Part I (admin),
Part II (quality), Part III
(non-clinical), Part IV
(clinical).
Module-2
(Summaries)
Module-2 holds high-
level summaries for
Modules 3–5.
Module-2 is retained;
summaries are indexed in
XML for reviewers.
No separate Module-2.
Summary elements are
embedded at the start of
each part.
XML/Backbone
No XML backbone (file-
based dossier).
Uses an XML backbone
(index.xml) for structure,
metadata, and lifecycle
actions.
No XML backbone;
navigation is table-of-
contents based.
Geographic
Acceptance
ICH regions and many
others accept CTD for
harmonized filings.
Mandatory or preferred in
key markets (FDA,
EMA); widely adopted
globally.
Targeted at ASEAN
regulators; used for
Southeast Asia filings.
Updates and
Versioning
Whole dossier
replacements or manual
updates; less automated.
Incremental updates
allowed; sequences track
changes and lifecycle.
Updates handled as
document sets per
submission; less
automated than eCTD.
Primary Advantage
Global harmonization;
reduced duplication
across regions.
Streamlined submissions,
reviewer-friendly
navigation, audit-ready.
Simpler, region-
appropriate format; useful
for resource-constrained
settings.
Best Use Case
Preparing a dossier for
ICH markets or multi-
region filings.
Any sponsor planning
lifecycle management and
multiple filings.
Mandatory in many
regions.
Quick regional
registrations across
ASEAN; first step for
some exporters.

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Complexity / Resource
Need
Moderate; requires
disciplined document
management.
Higher technical need
(XML tooling, validation,
lifecycle planning).
Lower technical
overhead; easier for local
companies to assemble.

Conclusion
CTD remains the global standard for harmonized dossiers in ICH regions. eCTD is the digital
powerhouse: it speeds updates, enforces version control, and eases regulator review. ACTD is
ASEAN-focused, lighter, and fit for resource-sensitive regional filings.
Choose the format based on your target region, filing cadence, and long-term roadmap. If
multiple lifecycle filings are planned, prioritize eCTD to future-proof workflows. Regulatory
teams should map their dossier strategy, assess gaps, and phase eCTD adoption as they scale.
Ready to streamline your regulatory submissions? Lifescience Intellipedia helps pharma
teams choose the right dossier format, align with global standards, and avoid costly delays.