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.
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.
- 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. |
| 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.
