- The common technical document (CTD) is a standard format used for submitting pharmaceutical applications to regulators in ICH countries.
- CTD consists of five modules that include administrative details, product quality, nonclinical studies, clinical studies, and region-specific requirements.
- Electronic CTD (eCTD) has become the preferred submission format in most regulatory regions, replacing paper-based applications.
- Module 3 (Quality) requires detailed manufacturing information such as batch records, validation data, and facility details.
- Most pharmaceutical companies need 6-12 months to prepare a complete CTD for a new drug application.
Pharmaceutical companies file thousands of regulatory submissions each year. Each country historically required different formats, different organization, and different documentation standards.
The common technical document solved this problem. Created through the International Council for Harmonisation (ICH), the CTD provides one universal format that regulatory agencies accept across major markets.
This guide explains how the CTD works, what each module contains, and how manufacturers prepare submissions that meet global regulatory standards.
What Is a Common Technical Document?
The common technical document is the internationally agreed format for pharmaceutical regulatory documentation submitted to health authorities. The CTD organizes all information about a drug’s safety, efficacy, and quality into five distinct modules.
The ICH developed this format through collaboration between regulatory authorities and pharmaceutical industry representatives from the U.S., Europe, and Japan. The goal was simple: create one structure that works everywhere.
Before the CTD, companies assembled completely different application packages for different countries. The FDA wanted information in one sequence. The European Medicines Agency (EMA) required a different organization. This created massive duplication of effort.
The CTD doesn’t eliminate all regional differences. Each region still has specific requirements for Module 1. But Modules 2-5 remain identical across all ICH regions, which represent the bulk of the technical content.
| CTD Module | Content Focus | Regional Variation | Typical Page Count |
| Module 1 | Administrative & prescribing info | Completely regional | 50-200 pages |
| Module 2 | Overviews and summaries | Identical across regions | 200-400 pages |
| Module 3 | Quality (chemistry, manufacturing) | Identical across regions | 500-1,500 pages |
| Module 4 | Nonclinical study reports | Identical across regions | 1,000-3,000 pages |
| Module 5 | Clinical study reports | Identical across regions | 2,000-10,000+ pages |
Understanding the regulatory strategy for drug development helps companies plan when and how to prepare CTD submissions throughout the development lifecycle.
The Five CTD Modules Explained
Each module serves a specific purpose in the regulatory review process. Reviewers from different disciplines focus on different modules based on their expertise.
Module 1: Administrative Information
This module varies completely by region. In the U.S., Module 1 contains FDA forms, proposed labeling, and administrative documents.
In Europe, it includes application forms and draft product information. In Japan, it contains documents specific to PMDA requirements.
Module 2: Common Technical Document Summaries
Module 2 provides high-level summaries that allow reviewers to quickly understand the key aspects of the application.
| Module 2 Section | Purpose | Target Audience |
| 2.3 – Quality Overall Summary | Summarizes manufacturing and controls | Chemistry reviewers |
| 2.4 – Nonclinical Overview | High-level view of animal studies | Pharmacology/toxicology reviewers |
| 2.5 – Clinical Overview | Key clinical data and conclusions | Medical reviewers |
| 2.6 – Nonclinical Written Summary | Detailed nonclinical results | Nonclinical specialists |
| 2.7 – Clinical Summary | Detailed clinical trial results | Clinical specialists |
These summaries help reviewers quickly identify potential issues before they dive into detailed reports.
Module 3: Quality
Module 3 contains all the chemistry, manufacturing, and controls (CMC) information. This module proves that the manufacturer can produce the drug consistently with acceptable quality standards.
From our experience working with pharmaceutical manufacturers, Module 3 often takes the longest to compile. It requires extensive documentation from multiple departments.
| Section | Content | Key Documents |
| 3.2.S – Drug Substance | API manufacturing and characterization | Synthesis flowcharts, specifications, stability data |
| 3.2.P – Drug Product | Final dosage form manufacturing | Formulation details, manufacturing process, container closure |
| 3.2.A – Appendices | Supporting analytical data | Validation reports, certificates of analysis |
| 3.2.R – Regional Information | Region-specific requirements | Varies by submission region |
The quality module must demonstrate compliance with current Good Manufacturing Practices (cGMP). Companies need detailed electronic batch record documentation, validation protocols, and analytical method validation data to support Module 3 claims.
Module 4: Nonclinical Study Reports
Module 4 contains reports from animal studies that assess safety and pharmacology. These studies evaluate how the drug works in animal models.
The module includes pharmacology studies, pharmacokinetic data, toxicology studies, and carcinogenicity studies when required.
Module 5: Clinical Study Reports
Module 5 contains detailed reports from all clinical trials conducted to support the application. This typically represents the largest portion of the CTD in terms of page count.
The module includes biopharmaceutics studies, efficacy trial results, safety data across all clinical studies, and special population studies. Each clinical study report follows a structured format defined by ICH E3 guidelines.
For products developed under the 505(b)(2) pathway, companies may reference existing clinical data. Understanding 505b2 drugs helps manufacturers determine which studies they need to conduct versus which can rely on published literature.
Understanding ICH M4 Guidelines
The ICH M4 guidelines provide the official specifications for how to organize a drug registration dossier.
| Guideline | Title | What It Covers |
| ICH M4(R4) | Common Technical Document Organization | Overall CTD structure and granularity |
| ICH M4S(R2) | Safety | Detailed requirements for nonclinical sections |
| ICH M4Q(R1) | Quality | Detailed requirements for quality sections |
| ICH M4E(R2) | Efficacy | Detailed requirements for clinical sections |
These guidelines specify the exact numbering system, section titles, and granularity level for organizing information. Following M4 precisely ensures regulatory agencies can find information quickly during their review.
CTD vs eCTD: Key Differences
The electronic Common Technical Document (eCTD) represents the next evolution of the CTD format.
While the underlying content organization remains identical, eCTD adds standardized file formats and electronic submission specifications.
| Feature | Paper/PDF CTD | Electronic CTD (eCTD) |
| Submission Format | Paper or simple PDF files | Structured XML with PDF content |
| Hyperlinks | Manual cross-references | Automated navigation between sections |
| Lifecycle Management | Complete resubmission of sections | Incremental updates tracked by sequence |
| Validation | Manual review only | Automated validation tools check structure |
| Agency Preference | Outdated in most regions | Required or strongly preferred |
| File Organization | Folders with documents | Backbone file with linked content |
The CTD vs eCTD difference matters because most regulatory agencies now require or strongly prefer eCTD submissions. The FDA mandated eCTD for most submission types.
eCTD submissions use a “backbone” XML file that defines the structure and points to individual PDF documents for each section.
Companies submit eCTD updates as numbered sequences. Sequence 0000 represents the initial application. Subsequent sequences contain only changed documents.
How to Prepare a CTD Submission
A successful CTD compilation process requires careful planning and cross-functional coordination. Most pharmaceutical companies need 6-12 months to assemble a complete new drug application.
Companies should define their target product profile early in development, as this guides what data to generate and how to present it in the CTD.
Phase 1: Planning (2-3 months before compilation)
Identify a submission lead who coordinates all contributors. Map out which departments provide which sections. Establish a master timeline with interim deadlines.
Phase 2: Content Generation (4-6 months)
Each functional area prepares their CTD sections:
| Department | Primary Responsibility | Key Deliverables |
| Regulatory Affairs | Modules 1 and 2, overall coordination | Summaries, overviews, administrative forms |
| Quality/CMC | Module 3 | Manufacturing descriptions, specifications, validation |
| Nonclinical | Module 4 | Toxicology and pharmacology study reports |
| Clinical | Module 5 | Clinical study reports, integrated summaries |
| Medical Writing | Support across modules | Formatting, editing, consistency checks |
Technical writing support proves valuable for consistent terminology and formatting across sections.
Phase 3: Review and Quality Control (1-2 months)
Senior scientists review technical content for accuracy. Regulatory affairs staff verify compliance with ICH M4 guidelines structure. Quality control teams check formatting and document numbering.
Phase 4: Assembly and Validation (2-4 weeks)
For eCTD submissions, technical specialists assemble the backbone XML file and validate the package. These tools check for structural errors and broken links.
CTD Format Requirements by Region
While Modules 2-5 remain identical across ICH regions, Module 1 requirements differ significantly.
| Region | Regulatory Agency | Module 1 Key Requirements | Submission Portal |
| United States | FDA | Forms 356h/1571, proposed labeling | FDA ESG or Gateway |
| European Union | EMA | Application forms, QRD-compliant info | EMA CESP Portal |
| Japan | PMDA | Japanese-language documents | PMDA eCTD Portal |
| Canada | Health Canada | Administrative forms, Canadian labeling | HC eCTD Portal |
| Australia | TGA | Evaluation fees, Australian documents | TGA Business Services |
Each region also has specific technical requirements for eCTD submission. File size limits and validation tool versions vary by agency.
For products that cover multiple development stages, understanding pharma regulatory compliance across these regions helps avoid costly submission errors.
Common CTD Preparation Challenges
From working with pharmaceutical manufacturers, we have observed that certain challenges appear repeatedly during CTD compilation.
Challenge 1: Inconsistent Data Across Studies
Clinical trials conducted over years may use different protocols or analytical methods. Explaining these differences clearly prevents reviewer concerns.
Challenge 2: Manufacturing Changes During Development
Companies often optimize their manufacturing process between early trials and commercial production. Module 3 must clearly describe these changes with comparability data.
Challenge 3: Missing Validation Data
Analytical methods and manufacturing processes all require validation. Companies sometimes discover gaps in validation documentation late in CTD preparation. These gaps can delay submissions by months.
Challenge 4: Cross-Reference Management
CTDs contain thousands of internal cross-references. Module 2 summaries reference detailed reports in Modules 3-5. Accurate tracking systems are essential.
Expert CTD Preparation Support for FDA-Regulated Manufacturers
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Frequently Asked Questions (FAQ) Related To Common Technical Documentation
What is the difference between CTD and eCTD?
CTD refers to the content organization defined by ICH M4 guidelines. eCTD is the electronic format for submitting that content using XML backbone files. Most agencies now require eCTD format.
How long does it take to prepare a CTD?
A complete new drug application typically requires 6-12 months to prepare. Complex biologics may need longer. Variations or supplements often take 2-4 months depending on scope.
Which module takes the longest to prepare?
Module 5 typically has the highest page count, but Module 3 often takes the longest calendar time. Module 3 requires input from multiple departments and extensive manufacturing documentation.
Do all countries accept the CTD format?
All ICH member regions (U.S., EU, Japan, Canada, Switzerland) accept and often require CTD format. Many non-ICH countries also accept CTD submissions.
Can I reuse CTD modules across different products?
Module 1 must be created specifically for each product and region. Modules 2-5 are product-specific and cannot be reused directly. However, companies may reuse certain sections with appropriate modifications.
