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Common Technical Document (CTD) Structure: Overview of Modules
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- Common Technical Document (CTD) Structure: Overview of Modules
An Academy Guide
- Why is the CTD Important?
- The Structure of the CTD
- Module 1: Administrative and Prescribing Information
- Module 2: CTD Summaries
- Module 3: Quality (Chemistry, Manufacturing, and Controls)
- Module 4: Nonclinical Study Reports
- Module 5: Clinical Study Reports
- Key Considerations When Preparing a CTD
- Conclusion
Interesting topics
Common Technical Document (CTD) Structure: Overview of Modules
The Common Technical Document (CTD) was developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and adopted by the Therapeutic Goods Administration (TGA) in 2004. [1], [2]
CTD is a set of specifications for a dossier that must be submitted to regulatory authorities (e.g., FDA, EMA, PMDA) when applying for the approval of a new pharmaceutical product. The CTD lays out a way to present all the data needed for harmonization (administrative, quality, safety, and efficacy), and supports agencies’ ability to read, assess, and review submissions.
1. Why is the CTD Important?
Harmonization: Allows pharmaceutical companies to file the same dossier with multiple regulatory agencies to save time and resources.
- Efficiency: A standardized format that facilitates quicker regulatory review.
- Clarity: A structured and consistent presentation of data.
- Compliance: Potential to ensure submission is following the regulations across regions (U.S, E.U., Japan)
2. The Structure of the CTD
The CTD is organized into five modules. Module 1 is region-specific. Modules 2, 3, 4, and 5 are intended to be common for all regions. Conformance with this guideline should ensure that these four modules are provided in a format acceptable to the regulatory authorities.[3]
2.1. Module 1. Administrative and Prescribing Information
The Module should include regional information, e.g., application and proposed label for use in the region. The contents of this module and the format of the submission can be specified by the regulatory authority.[3]
2.2. Module 2. CTD Summaries
Module 2 should begin with a general introduction to the drug product(s), e.g., the pharmacologic class, mode of action, and proposed clinical use for the product information. Generally, the introduction should be no more than one page.[3]
Module 2 should contain 7 sections in the following order:
- CTD Table of Contents
- CTD Introduction
- Quality Overall Summary
- Nonclinical Overview
- Clinical Overview
- Nonclinical Written and Tabulated Summaries
- Clinical Summary
2.3. Module 3. Quality
Quality information should be provided in the structure described in Guideline M4Q.
2.4. Module 4. Nonclinical Study Reports
Nonclinical study reports should be presented in the order described in Guideline M4S.
Image adapted from the ICH Official website: ICH. (n.d.). Ich.org. Retrieved August 16, 2025, from https://www.ich.org/page/ctd
3. Key Considerations When Preparing a CTD
- Accuracy and Consistency: Especially consistency and accuracy in the data across modules, and how the data matches the summaries.
- Clear Documentation: Clear wording commonly used structured templates, and no repeated documents.
- Data Integrity: The traceability and validity of the data, such as from clinical and nonclinical studies.
- Timeliness: Planning for timelines, especially as the preparation is resource-intensive and can have unrealistic timelines.
- Electronic Submission: Most regions now expect eCTD as the submission format, and technical issues related to compliance need to be considered.
Conclusion
The CTD is an important element in global pharmaceutical regulation, facilitating submission and review. It is important to understand its structure and prepare the CTD appropriately. By following the standard CTD format, pharmaceutical companies can save time, improve efficiency, eliminate duplication, and enhance the quality of the submissions to enable medicines to be delivered to patients more quickly and efficiently.
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References
- ICH Official web site : ICH. (n.d.). Ich.org. Retrieved August 16, 2025, from https://www.ich.org/page/ctd
- (N.d.). Gov.au. Retrieved August 16, 2025, from https://www.tga.gov.au/resources/guidance/understanding-common-technical-document-ctd
- (N.d.). Europa.Eu. Retrieved August 16, 2025, from https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-m4-r4-common-technical-document-ctd-registration-pharmaceuticals-human-use-organisation-ctd-step-5_en.pdf