What is the Common Technical Document?
The Common Technical Document (CTD) is an internationally agreed format for preparing regulatory submissions for the registration of human pharmaceuticals. Developed through the International Council for Harmonisation (ICH), the CTD provides a standardized structure that facilitates the review process and reduces duplication of effort across different regulatory authorities.
The CTD is accepted by regulatory authorities in the European Union, United States, Japan, Canada, Switzerland, and many other countries, making it the global standard for marketing authorization applications.
Key Benefits of the CTD Format
- Standardized structure recognized globally
- Reduced preparation time for multi-regional submissions
- Improved efficiency in regulatory review
- Clear organization of quality, safety, and efficacy data
The Five Modules of the CTD
The CTD is organized into five modules, each serving a specific purpose in the regulatory submission:
Module 1: Regional Administrative Information
Module 1 is region-specific and contains administrative documents required by the particular regulatory authority. This includes application forms, product information (SmPC, labeling), and other administrative documents. The content varies by region (EU, US, Japan, etc.).
Key Components:
- Application forms and cover letters
- Product information (SmPC, PIL, labeling)
- Information about experts and manufacturing sites
- Environmental risk assessments (where applicable)
Module 2: Common Technical Document Summaries
Module 2 provides high-level summaries and overviews of the quality, nonclinical, and clinical information presented in Modules 3, 4, and 5. This module is critical as it's often the first section reviewed by assessors.
Key Sections:
- 2.3: Quality Overall Summary (QOS)
- 2.4: Nonclinical Overview
- 2.5: Clinical Overview
- 2.6: Nonclinical Written and Tabulated Summaries
- 2.7: Clinical Summary
Module 3: Quality (Chemistry, Manufacturing, and Controls)
Module 3 contains detailed information on the drug substance (active pharmaceutical ingredient) and drug product (finished dosage form), including manufacturing processes, specifications, analytical methods, and stability data.
Main Sections:
- Drug Substance (API) information
- Drug Product (finished product) information
- Manufacturing process and controls
- Specifications and analytical procedures
- Stability data and shelf-life justification
- Container closure system
Module 4: Nonclinical Study Reports
Module 4 presents the complete nonclinical (preclinical) study reports, including pharmacology, pharmacokinetics, and toxicology studies conducted in animals and in vitro systems.
Study Categories:
- Pharmacology studies (primary and secondary)
- Pharmacokinetic and ADME studies
- Toxicology studies (acute, repeat-dose, genotoxicity, carcinogenicity)
- Reproductive and developmental toxicity
- Local tolerance studies
Module 5: Clinical Study Reports
Module 5 contains the complete clinical study reports from all clinical trials conducted to support the safety and efficacy of the medicinal product. This is typically the largest module in terms of volume.
Clinical Documentation:
- Clinical study reports (CSRs) following ICH E3 format
- Study protocols and amendments
- Sample case report forms
- Individual patient data listings
- Bioavailability and bioequivalence studies
- Post-marketing experience reports
Critical Sections: Module 2.5 and 2.7
Among all CTD sections, Module 2.5 (Clinical Overview) and Module 2.7 (Clinical Summary) are particularly critical as they provide the primary clinical narrative and data summaries that assessors use to evaluate the benefit-risk profile of the medicinal product.
Module 2.5: Clinical Overview
The Clinical Overview provides a critical analysis of the clinical data, presenting the applicant's interpretation of the data and how it supports the proposed indication, dosing, and safety profile. It should be written by a clinically qualified expert and typically ranges from 30-50 pages.
Module 2.7: Clinical Summary
The Clinical Summary provides detailed factual summaries of clinical information, including integrated analyses of efficacy and safety data across studies. It includes extensive tables, figures, and listings that support the conclusions drawn in Module 2.5.
Best Practices for CTD Preparation
- Start early and maintain a well-organized document management system
- Ensure consistency across all modules and summaries
- Use clear, concise scientific writing appropriate for regulatory review
- Follow ICH M4 guidance documents precisely
- Conduct thorough quality control and cross-referencing
- Prepare electronic submissions according to eCTD specifications
Electronic Common Technical Document (eCTD)
The eCTD is the electronic format of the CTD, providing a standardized structure for electronic submissions. Most regulatory authorities now require or prefer eCTD format, which offers advantages in terms of submission efficiency, review speed, and lifecycle management.
The eCTD uses XML backbone files to organize the submission and allows for efficient submission of variations and updates throughout the product lifecycle.
How We Can Help
At Noetus Solutions, we provide comprehensive support for CTD preparation and submission:
- Complete CTD dossier compilation and authoring
- Module 2.5 and 2.7 medical writing services
- Quality review and gap analysis of existing CTD documents
- eCTD publishing and validation
- Regulatory strategy and submission planning
- Post-submission support and responses to regulatory questions
Need Expert CTD Support?
Our team has extensive experience in preparing CTD submissions for marketing authorization applications across multiple therapeutic areas and regulatory regions. Contact us to discuss your regulatory submission needs.