Table of Content
The Common Technical Document (CTD) is a standardized format for submitting regulatory applications for pharmaceutical products. It is used by regulatory agencies around the world, including the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).
The CTD is divided into five main sections:
- Administrative information and prescribing information: This section includes information on the marketing authorization holder (MAH), the product’s brand name and generic name, and the intended use of the product. It also includes the product’s summary of product characteristics (SmPC) and patient information leaflet (PIL), which provide important information for healthcare professionals and patients on the use, dosage, and potential side effects of the product.
- Quality: This section provides information on the quality and manufacturing of the product, including the pharmaceutical form, composition, and methods of manufacture. It also includes data on the stability of the product and a description of the manufacturing site.
- Nonclinical study reports: This section includes nonclinical studies that have been conducted to evaluate the safety and effectiveness of the product. These may include studies on the product’s pharmacology, toxicology, and environmental impact.
- Clinical study reports: This section includes clinical studies that have been conducted to evaluate the efficacy and safety of the product in humans. These may include data on the study design, population, results, and any adverse events that occurred during the study.
- Manufacturing and control: This section provides information on the manufacturing process and controls used to ensure the quality and consistency of the product. It may include data on the raw materials, intermediates, and finished product, as well as information on the equipment and controls used in the manufacturing process.
The CTD format helps to ensure that all relevant information is provided to regulatory agencies in a consistent and standardized way. It is an important tool for facilitating the review and approval process for new pharmaceutical products.
Few more points about the Common Technical Document (CTD):
- The CTD format is used for both new drug applications and supplemental applications, which are used to request changes to an already approved product.
- The CTD format is used for both small molecule and biologics products. However, the specific sections and data requirements may vary depending on the type of product.
- The CTD format is designed to be flexible and allow for the inclusion of additional information as needed. It is not a one-size-fits-all template, and the data requirements may vary depending on the specific product and regulatory agency.
- The CTD format is not the only format used for regulatory submissions. Other formats, such as the Electronic Common Technical Document (eCTD), are also used by some regulatory agencies.
- The CTD format is continually being updated to reflect advances in science and technology and to ensure that regulatory submissions are as efficient and effective as possible.
- In addition to the five main sections, the CTD may also include appendices, such as translations of the SmPC and PIL, or other supporting information.
Overall, the CTD is an important tool for ensuring the safety and effectiveness of pharmaceutical products by providing regulatory agencies with the information they need to make informed decisions about their approval. It is a key component of the drug development and regulatory process.
CTD or ECTD has five modules:
Module 1: Administrative information and prescribing information
Module 2: Overviews and Summaries of Modules 3–5
Module 3: Quality (pharmaceutical documentation)
Module 4: Non-clinical reports (pharmacology/toxicology)
Module 5: Clinical study reports (clinical trials)
Module 1. Administrative Information and Prescribing Information of CTD
This module should contain documents specific to each region; for example, application forms or the
proposed label for use in the region. The content and format of this module can be specified by the
relevant regulatory authorities.
Due to the fact that Module 1 comprises papers unique to each region, such as application forms and the proposed label, it is not precisely included in the CTD. Since the content and format of this module are unique to each Regulatory Authority, further discussion of it in this article is not necessary.
Module 2. Common Technical Document Summaries of CTD
Module 2 should begin with a general introduction to the pharmaceutical, including its pharmacologic
class, mode of action, and proposed clinical use. In general, the Introduction should not exceed one
page.
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
Module 3. Quality of CTD
Information on Quality should be presented in the structured format described in Guideline M4Q.
The chemical, production, and controls reports for the product listed in the registration dossier are presented in Module 3. The ICH M4Q guideline provides comprehensive specifics of what should be covered in Module 3 in its entirety. This module has 5 sections that provide both drug substance and drug product information. The section’s primary headings include
Module 4. Nonclinical Study Reports of CTD
The nonclinical study reports should be presented in the order described in Guideline M4S.
The CTD Safety (M4S) Guideline specifies the organisation of Module 4—the Nonclinical Study Reports—and the structure and format of the nonclinical summaries in Module 2 of the Common Technical Document. The Nonclinical Overview, which typically does not exceed 30 pages, should give a comprehensive and critical assessment of the pharmacologic, pharmacokinetic, and toxicologic examination of the medication. It is advised to give more thorough summaries and discussion of the nonclinical information on pharmacology, pharmacokinetics, and toxicology in the Nonclinical Written Summaries (100-150 pages). For the creation of the Nonclinical Tabulated Summaries, 34 templates are provided, along with 31 sample tables. Finally, a description of the Nonclinical Study Reports organisation in Module 4 follows.
Module 5. Clinical Study Reports of CTD
The human study reports and related information should be presented in the order described in Guideline M4E.The clinical reports included in the dossier are presented in Module 5. The ICH M4E guidelines9, which offered a particular location of clinical research reports and supporting information to simplify preparation and review and to ensure completeness, specify the structure and content of Module 5. Each report only appears in one area, and its placement is chosen by the main goal of the study. The study should be cross-referenced in the various sections if there are several objectives.
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