What is CTD?
The Common Technical Document (CTD) is an internationally harmonized format for organizing pharmaceutical product data — including quality, safety, and efficacy information — into a five-module dossier structure. Developed by the International Council for Harmonisation (ICH), CTD is now the universally accepted standard for regulatory submissions to authorities such as the EMA, US FDA, CDSCO, and Health Canada.
By standardizing the document structure across regions, CTD eliminates the need for companies to prepare entirely different submission packages for each country — dramatically reducing time-to-market and cost of global drug registration. Most modern regulatory agencies now mandate its electronic version, known as the eCTD (electronic Common Technical Document).
CTD Structure
The ICH CTD format organizes pharmaceutical product information into five distinct modules. Understanding each module is essential for a complete and compliant regulatory submission. Below is a structured overview of what each module contains and why it matters.
The only country-specific module in the CTD. Its content is customized according to the regulatory requirements of each target country or region. This is where cover letters, application forms, and country-specific labeling are compiled.
A structured summary of Modules 3, 4, and 5 — designed to provide regulatory reviewers with a concise, high-level overview of the entire dossier. It includes the Quality Overall Summary (QOS), Nonclinical Overview, and Clinical Summary.
Contains comprehensive Chemistry, Manufacturing, and Controls (CMC) information for both the drug substance (API) and drug product. Covers manufacturing processes, specifications, stability studies, and container closure systems.
Compiles all preclinical data from animal and in vitro studies that demonstrate the safety profile of the drug. This includes pharmacological, toxicological, and pharmacokinetic evaluations conducted prior to first-in-human trials.
The most critical module for demonstrating human safety and efficacy. Includes Phase I–III clinical trial reports, bioavailability/bioequivalence data, biostatistics, and post-marketing pharmacovigilance plans.
Related: What is Module 2.4? A Guide to the Nonclinical Summary Section | What Is a Regulatory Dossier? A Complete Guide
ASEAN Markets
The ASEAN Common Technical Dossier (ACTD) is the regional adaptation of the ICH CTD, developed specifically for pharmaceutical product registration across ASEAN member states including Malaysia, Thailand, Philippines, Indonesia, Vietnam, Singapore, and others. If you are targeting ASEAN markets, your dossier must follow ACTD structure — not standard CTD.
While the ACTD is broadly based on the ICH CTD framework, it has distinct structural differences — particularly in the arrangement of quality, nonclinical, and clinical sections. Understanding these differences is essential to avoid costly rejections.
| Aspect | ICH CTD | ACTD |
|---|---|---|
| Total Parts | 5 Modules | 4 Parts |
| Administrative Info | Module 1 | Part I |
| Quality (CMC) | Module 3 | Part II |
| Nonclinical | Module 4 | Part III |
| Clinical | Module 5 | Part IV |
| Scope | Global | ASEAN Region |
MedWisdom Lifescience offers expert ACTD dossier compilation services customized for each ASEAN member state's regulatory authority requirements — from NPRA Malaysia to FDA Thailand and BPOM Indonesia.
Why CTD?
Adopting the CTD format is not just a regulatory requirement — it is a strategic advantage that accelerates approvals and opens doors to global markets.
CTD is accepted by 60+ regulatory agencies worldwide, including EMA, USFDA, Health Canada, CDSCO, ANVISA, PMDA, and SFDA — enabling a true "one dossier, multiple submissions" strategy.
The structured, reviewer-friendly format reduces back-and-forth queries from regulatory agencies, accelerating the overall review timeline and time-to-market.
A single CTD core (Modules 2–5) can be reused across multiple countries, with only Module 1 adapted per country — saving significant resources and preparation time.
The standardized format ensures that quality, safety, and efficacy data are consistently organized, making it easier for reviewers to locate and cross-reference information.
Document Checklist
A successful CTD dossier relies on the completeness and quality of the source documents provided. Below is a reference checklist of the most critical documents our team will need from your organization. Our experts will conduct a gap analysis before commencing work to identify any missing or incomplete data.
| Document | Abbreviation | Relevant CTD Module | Purpose |
|---|---|---|---|
| Drug Master File | DMF | Module 3 (Drug Substance) | API manufacturer quality and manufacturing data |
| Process Validation Report | PVR | Module 3 (Drug Product) | Confirms manufacturing process consistency |
| Batch Manufacturing Record | BMR | Module 3 | Documents actual batch production details |
| Batch Protocol Report | BPR | Module 3 | Records results of batch testing |
| Stability Data (Accelerated & Long-Term) | — | Module 3 | Demonstrates shelf-life and storage conditions |
| Master Formula Record | MFR | Module 3 | Product formulation and composition details |
| Finished Product Specifications | — | Module 3 | Release and shelf-life specifications for the FPP |
| Excipient Specifications | — | Module 3 | Quality standards for each excipient used |
| Nonclinical Study Reports | — | Module 4 | Animal/in vitro safety and pharmacology data |
| Clinical Study Reports | CSR | Module 5 | Human clinical trial efficacy and safety data |
Don't have all documents ready? Our regulatory team can advise on acceptable alternatives and help you prioritize. Contact us to start a gap assessment.
Our Process
With over a decade of experience in pharmaceutical regulatory affairs, MedWisdom Lifescience provides a systematic, quality-assured approach to CTD and ACTD dossier preparation — from initial gap analysis to final submission-ready package.
We assess your target countries, product category, and existing documents to build a tailored regulatory roadmap aligned with applicable guidelines.
Our team reviews all submitted source documents against the relevant CTD/ACTD requirements and provides a detailed gap report before preparation begins — preventing costly delays downstream.
Our regulatory writers compile each module in strict adherence to ICH M4 guidelines, country-specific variations, and eCTD technical specifications where required.
Every dossier undergoes an internal QC review by a senior regulatory consultant before handover, ensuring completeness, consistency, and compliance.
We support you through the submission process and remain available to address regulatory queries, additional information (AI) requests, and deficiency letters from the authority.
"MedWisdom's team delivered a complete CTD dossier for our EU submission within one week. Their regulatory expertise saved us months of back-and-forth with the authority."
— [Client Name], Regulatory Affairs Manager, [Company Name]
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FAQs
Have questions about the CTD dossier process? Here are the most common questions we receive from pharmaceutical and biotech companies.
Pharmaceutical manufacturers, generic drug companies, biotech firms, and medical device manufacturers all require CTD dossier preparation when seeking product registration in any country that mandates the ICH CTD format. This includes most of Europe, North America, Japan, Australia, and an increasing number of emerging markets. Companies entering multiple markets benefit most from a centralized CTD dossier strategy.
The preparation timeline primarily depends on the availability and completeness of source technical documents from your organization. Once all required documents are received, our team typically completes a full CTD dossier compilation in 5–6 business days. Complex products (biologics, combination products) or multi-country dossiers may require additional time, which will be clearly communicated upfront.
Yes, the ICH CTD format (Modules 2–5) is recognized and accepted by the vast majority of major regulatory authorities globally. However, Module 1 (Administrative Information) must be customized for each country, as it contains region-specific documents such as the application form, labeling, and certificates. ASEAN countries use the adapted ACTD format. A few emerging markets may have their own dossier formats, but most are transitioning toward CTD or accepting it with minor modifications.
The CTD defines the content and structure of the regulatory dossier, while the eCTD (electronic Common Technical Document) is the electronic format and submission standard for delivering that CTD content digitally to regulatory agencies. The eCTD uses a specific file structure, XML backbone, and lifecycle management features. Most major agencies — including the US FDA, EMA, and Health Canada — now mandate eCTD submissions. MedWisdom provides both CTD compilation and eCTD publishing services.
The most critical documents required include the Drug Master File (DMF), Process Validation Report (PVR), Batch Protocol Report (BPR), Batch Manufacturing Record (BMR), accelerated and long-term stability data, Master Formula Record (MFR), and specifications for the finished product and all excipients. Clinical study reports and nonclinical study reports are also required for Modules 4 and 5. Our team will provide a complete checklist and conduct a gap analysis before work begins.
Related reading: What is a Drug Master File (DMF)? | eCTD Submission Latest Validation Criteria