eCTD Submission before any pharmaceutical product reaches the market, it must receive approval from the country’s regulatory authority. To obtain this approval, pharmaceutical companies submit a regulatory dossier containing scientific, technical, clinical, and quality information demonstrating that the product is safe, effective, and consistently manufactured.
Over the years, regulatory agencies have standardized dossier formats to simplify product evaluation and promote global harmonization. Today, the four most commonly used dossier formats are:
- CTD (Common Technical Document)
- eCTD (Electronic Common Technical Document)
- ACTD (ASEAN Common Technical Dossier)
- eACTD (Electronic ASEAN Common Technical Dossier)
Although these formats serve the same purpose—supporting drug registration—they differ in structure, submission method, regional acceptance, and technical requirements.
This article explains each dossier format in simple language, highlights their differences, and helps regulatory professionals understand which format is required for different markets.
What Is a Pharmaceutical Dossier- eCTD Submission?
A pharmaceutical dossier is a collection of documents submitted to a regulatory authority to obtain marketing authorization for a medicinal product.
The dossier contains information about:
- Administrative documents
- Product quality
- Manufacturing process
- Stability studies
- Non-clinical studies
- Clinical studies
- Product labeling
- Risk assessment
Regulatory agencies review these documents to determine whether the medicine meets their requirements for quality, safety, and efficacy.
Why Standardized Dossier Formats Important?
Before standardized formats were introduced, pharmaceutical companies had to prepare different dossiers for different countries. This increased workload, delayed approvals, and often resulted in duplicate documentation.
Standardized dossier formats help by:
- Reducing duplicate work
- Improving consistency
- Simplifying regulatory review
- Supporting global submissions
- Facilitating lifecycle management
- Reducing approval timelines
What is CTD vs eCTD Submission
The Common Technical Document (CTD) is an internationally harmonized format developed by the International Council for Harmonisation (ICH).
Instead of changing scientific requirements, CTD standardizes how information is organized and presented.
Today, CTD is accepted in many countries worldwide.
Objectives of CTD
The main objectives of CTD are to:
- Harmonize regulatory submissions
- Reduce duplication of documentation
- Improve review efficiency
- Support simultaneous global submissions
- Simplify dossier preparation
CTD Structure
The CTD consists of five modules.
| Module | Description |
| Module 1 | Regional Administrative Information |
| Module 2 | CTD Summaries |
| Module 3 | Quality (CMC) |
| Module 4 | Non-clinical Study Reports |
| Module 5 | Clinical Study Reports |
Module 1 – Regional Information
Module 1 is country-specific.
Typical contents include:
- Application form
- Cover letter
- Labeling
- Package insert
- Product information
- Certificates
- Environmental risk assessment (where applicable)
Every regulatory agency has its own Module 1 requirements.
Module 2 – Summaries
Module 2 provides summaries of the detailed information contained in Modules 3, 4, and 5.
It includes:
- Quality Overall Summary (QOS)
- Non-clinical Overview
- Clinical Overview
- Written Summaries
Module 3 – Quality (CMC)
This module describes product quality.
Typical sections include:
- Drug Substance
- Drug Product
- Manufacturing Process
- Specifications
- Analytical Methods
- Method Validation
- Batch Analysis
- Container Closure System
- Stability Studies (includes stability data that demonstrate a product maintains its quality throughout its shelf life. To understand how these studies are designed and conducted. Read our Pharmaceutical Stability Studies: Protocol, Storage Conditions guide)
Module 3 is one of the most important sections for both innovator and generic products.
Module 4 – Non-clinical Studies
Module 4 contains laboratory and animal study reports.
Examples include:
- Toxicology
- Pharmacology
- Safety Pharmacology
- Genotoxicity
- Reproductive Toxicity
Module 5 – Clinical Studies
Module 5 includes studies conducted in humans.
Examples include:
- Bioequivalence Studies
- Phase I Studies
- Phase II Studies
- Phase III Studies
- Clinical Safety Reports
What Is eCTD – eCTD Submission?
The Electronic Common Technical Document (eCTD) is the electronic version of CTD.
Rather than submitting paper files or simple PDFs, eCTD uses a standardized electronic structure defined by ICH. Documents are organized into folders and linked using XML backbone files, making navigation and review more efficient.
Regulatory authorities can quickly search, review, and track changes across multiple submissions.
Why eCTD was Introduced?
Paper submissions were often bulky, difficult to manage, and time-consuming to review. eCTD was introduced to improve efficiency by:
- Eliminating paper-based dossiers
- Standardizing electronic submissions
- Supporting lifecycle management
- Simplifying updates and variations
- Improving document traceability
Key Features of eCTD
- Electronic folder structure
- XML backbone
- Hyperlinked documents
- Automatic validation
- Lifecycle management
- Sequence-based submissions
- Faster regulatory review
What is eCTD Sequence?
Every submission made after the initial application is called a sequence.
Examples include:
- Initial Submission
- Response to Queries
- Variation
- Renewal
- Label Update
- Site Change
- Withdrawal
Each sequence updates or replaces specific documents while preserving the complete regulatory history.
Advantages of eCTD Submission
Compared with paper CTD, eCTD offers several advantages:
- Faster dossier compilation
- Reduced printing and shipping costs
- Easier document navigation
- Improved lifecycle management
- Efficient review by regulatory agencies
- Better version control
- Reduced storage requirements
- Environmentally friendly
What Is ACTD?
The ASEAN Common Technical Dossier (ACTD) is the standardized dossier format developed for pharmaceutical product registration within the Association of Southeast Asian Nations (ASEAN).
ACTD follows the same overall objective as CTD but uses a different structure designed specifically for ASEAN regulatory authorities.
Countries Commonly Using ACTD
ACTD is used in many ASEAN member states, including:
- Singapore
- Malaysia
- Thailand
- Indonesia
- Philippines
- Vietnam
- Brunei
- Cambodia
- Laos
- Myanmar
Each authority may have country-specific administrative requirements in addition to the ACTD format.
ACTD Structure
Unlike CTD, ACTD is divided into four parts.
| Part | Description |
| Part I | Administrative Data and Product Information |
| Part II | Quality Documentation |
| Part III | Non-clinical Documentation |
| Part IV | Clinical Documentation |
Part I
Contains:
- Application forms
- Product labels
- Package insert
- Certificates
- Administrative documents
Part II
Contains quality information similar to CTD Module 3:
- Drug substance
- Drug product
- Manufacturing process
- Validation
- Specifications
- Stability
Part III
Contains non-clinical reports.
Part IV
Contains clinical documentation.
What Is eACTD?
eACTD is the electronic version of ACTD.
Instead of paper submissions, documents are submitted electronically following the technical requirements established by individual ASEAN regulatory authorities.
Although eACTD shares the concept of electronic submission with eCTD, the technical specifications and implementation may differ between countries.
CTD vs eCTD
| Feature | CTD | eCTD |
| Submission | Paper or PDF | Electronic |
| Lifecycle Management | Limited | Yes |
| XML Backbone | No | Yes |
| Hyperlinks | Optional | Required |
| Validation | Manual | Automated |
| Review Speed | Moderate | Faster |
| Global Acceptance | High | Increasingly Mandatory |
ACTD vs eACTD
| Feature | ACTD | eACTD |
| Submission | Paper | Electronic |
| Lifecycle | Limited | Better |
| Electronic Validation | No | Yes |
| Hyperlinks | Limited | Required |
| Review | Manual | Faster |
CTD vs ACTD
| Feature | CTD | ACTD |
| Developed By | ICH | ASEAN |
| Structure | Five Modules | Four Parts |
| Global Acceptance | Worldwide | ASEAN |
| Module 1 | Regional | Part I |
| Quality Section | Module 3 | Part II |
| Clinical Section | Module 5 | Part IV |
Comparison of All CTD eCTD ACTD eACTD
| Parameter | CTD | eCTD | ACTD | eACTD |
| Paper Submission | Yes | No | Yes | No |
| Electronic Submission | Limited | Yes | Limited | Yes |
| XML Backbone | No | Yes | No | Depends on Authority |
| Lifecycle Management | Limited | Excellent | Limited | Moderate |
| Main Region | Global | Global | ASEAN | ASEAN |
| Review Efficiency | Good | Excellent | Good | Very Good |
Which Dossier Format Should You Use?
The required format depends on the regulatory authority where the product will be registered.
For example:
- Many ICH-aligned authorities now expect eCTD submissions.
- Several ASEAN authorities continue to use ACTD or are transitioning toward eACTD.
- Some markets still accept CTD in specific circumstances, while others have fully adopted electronic submissions.
Always verify the current submission requirements with the target country’s regulatory authority before preparing a dossier.
Best Practices for Dossier Preparation
- Follow the latest regulatory guidance for the target market.
- Use a consistent document naming convention.
- Ensure all hyperlinks and bookmarks function correctly.
- Keep documents clear, complete, and free of inconsistencies.
- Validate electronic dossiers before submission.
- Maintain a controlled document management system.
- Plan for lifecycle updates from the beginning of the project.
Common Mistakes to Avoid eCTD Submission
- Submitting documents in the wrong module or part.
- Using outdated templates or guidance.
- Missing required administrative documents.
- Inconsistent product information across sections.
- Broken hyperlinks in electronic submissions.
- Incomplete stability or validation data.
- Poor version control during dossier updates.
Frequently Asked Questions (FAQs) regarding eCTD Submission
Q-1. What is the purpose of a pharmaceutical dossier?
Answer: A pharmaceutical dossier provides the scientific and technical information that regulatory authorities need to evaluate a medicine’s quality, safety, and efficacy before granting marketing approval.
Q-2. What is the difference between CTD and eCTD?
Answer: CTD refers to the standardized content and structure of a dossier, while eCTD is the electronic format used to submit that dossier with standardized electronic organization and lifecycle management.
Q-3. Is CTD still accepted?
Answer: Acceptance varies by country. Many regulatory authorities have transitioned to mandatory eCTD submissions, while some still accept CTD in specific situations.
Q-4. What is ACTD used for?
Answer: ACTD is primarily used for pharmaceutical product registration in ASEAN countries.
Q-5. What is eACTD?
Answer: eACTD is the electronic version of the ASEAN Common Technical Dossier used by some ASEAN regulatory authorities.
Q-6. What is Module 3 in CTD?
Answer: Module 3 contains Chemistry, Manufacturing, and Controls (CMC) information, including details about the drug substance, drug product, manufacturing process, analytical methods, specifications, and stability.
References used for eCTD Submission
- ICH M8 – Electronic Common Technical Document (eCTD) Specification.
- World Health Organization (WHO) guidance on marketing authorization of pharmaceutical products.