Common Technical Document (CTD), Pharmaceutical Regulatory Science Notes
Common Technical Document (CTD) introduction
The Common Technical Document (CTD) is a set of specifications for an application dossier for the registrations of Medicines and is designed to be used across Europe, Japan and the United States.
It is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries. Prior to the implementation of the Common Technical Document (CTD) in 2002, each of the three major regulatory regions (European Union, USA and Japan) had its own set of guidelines and format for the submission of a regulatory dossier to obtain marketing approval for a new drug or the variation to the licensing of an existing drug.
In 2000, representatives from the European Medicines Agency (EMA), the USFDA and the Ministry of Health Labor and Family Welfare in Japan developed a set of guidelines defining the structure and content of the dossier for an application for the registration of a new medicine that could be used across all three regions.
These guidelines were developed under the umbrella of the International Council on Harmonization (ICH) and are part of ICH guidelines.
Aim of CTD
The aim of CTD was to provide a common format for the technical documentation that could significantly reduce the time and resources needed to compile applications for registrations of human pharmaceuticals and would be facilitated by a standard document of common elements and the exchange of regulatory information between Regulatory authorities would be simplified.
The first set of ICH CTD guidelines was published in 2002 and currently, there are four ICH guidelines on the CTD (M4. M4Q, M45, and M4E).
General Principles
Throughout the Common Technical Document, the display of information should be unambiguous and transparent, in order to facilitate the review of the basic data and to help a reviewer to become quickly oriented to the application contents. Texts and tables should be prepared using margins that allow the document to be printed on both A4 paper (EU and Japan) and 8.5×11″ paper (US). The left-hand margin should be sufficiently large so that information is not obscured by the method of binding. Font sizes for text and tables should be a style and size that are large enough to be easily legible, even after photocopying. Times New Roman, 12- point font, is recommended for narrative text. Every page should be numbered, according to the granularity document.
Organization of the Common Technical Document
The Common Technical Document 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 guidelines should ensure that these four modules are provided in a format acceptable to the regulatory authorities.
Module 1: Administrative Information and prescribing information
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.
- 1.1 Table of Contents of the Submission including Module 1.
- 1.2 Documents Specific to Each Region (for example, application forms, prescribing information).
Module 2: Common Technical Document Summaries
Module 2 should begin with a general introduction to the pharmaceutical, including Its pharmacologic class, mode of action and propped clinical use. In general, the introduction should not exceed one page. Module 2 should contain seven sections in the following order: CTD Table of contents. CTD introduction. Quality Overall Summary. Non-clinical overview. Clinical Overview. Non-clinical Written and Tabulated Summaries. Clinical Summary. The organization of these summaries is described in the guidelines for M4Q, M4S and M4E
- 2.1 Common Technical Document Table of contents (Modules 2-5).
- 2.2 CTD Introduction.
- 2.3 Quality overall summary.
- 2.4 Non-clinical overview.
- 2.5 Clinical overview.
- 2.6 Non-clinical written and tabulated summaries: Pharmacology Pharmacokinetics Toxicology.
- 2.7 Clinical summary: Biopharmaceutical studies and associated analytical methods, Clinical pharmacology studies, Clinical efficacy, Clinical safety, Literature references, and Synopses of individual studies.
Module 3: Quality
Information on quality should be presented in the structured format described in Guidelines M4Q.
- 3.1 Table of contents of Module
- 3 3.2 Body of data
- 3.3 Literature references
Module 4: Non-clinical Study Reports
The non-clinical study reports should be presented in the order described in the guidelines M4S.
- 4.1 Table of contents of Module
- 4 4.2 Study reports
- 4.3 Literature references
Module 5: Clinical Study Reports
The human study reports and related information should be presented in the order described in guidelines M4E.
- 5.1 Table of contents of Module
- 5 5.2 Tabular listing of all clinical studies
- 5.3 Clinical study reports
- 5.4 Literature references
Frequently Asked Questions (FAQs) on CTD Format
The Common Technical Document (CTD) format is a standard format for submitting regulatory information on pharmaceuticals to regulatory authorities, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Here are some frequently asked questions to help you understand the CTD format in pharmaceutical regulatory science
The CTD format is an internationally recognized standardized format for organizing and presenting regulatory information related to the development, registration, and approval of pharmaceutical products.
The CTD format streamlines the submission process for pharmaceutical regulatory applications by providing a consistent and organized structure for presenting data, studies, and other information required for regulatory evaluation.
The CTD format consists of five main modules:
Module 1: Administrative and Prescribing Information
Module 2: Summaries of the Quality, Safety, and Efficacy Data
Module 3: Quality
Module 4: Nonclinical Study Reports
Module 5: Clinical Study Reports
The CTD format facilitates efficient and effective communication between pharmaceutical companies and regulatory agencies. It allows reviewers to quickly locate and assess relevant information, leading to faster and more consistent evaluation processes.
While the CTD format is widely accepted and recommended by regulatory agencies, its adoption can vary by region. Many countries, including the U.S. and European Union, encourage the use of CTD for regulatory submissions.
The CTD format can streamline the regulatory submission process, potentially reducing the time required for regulatory approval. It helps avoid delays caused by disorganized or incomplete submissions.
Clinical data is presented in Module 5 of the CTD, which includes summaries of clinical study reports, patient exposure data, safety and efficacy results, and other relevant information from clinical trials.
Yes, the CTD format is adaptable and can be used for various types of pharmaceutical products, including new drug applications, biologics, generic drugs, and over-the-counter medications.
Benefits of using the CTD format include improved organization of data, reduced likelihood of deficiencies, enhanced communication with regulatory agencies, and potentially expedited regulatory approvals.
Pharmaceutical companies should ensure that they have comprehensive and accurate data, studies, and reports for each module of the CTD. Consulting regulatory guidelines specific to the intended region is essential.
Yes, regulatory agencies provide detailed guidelines on formatting, content, and organization of documents within each module of the CTD format. Adhering to these guidelines is crucial for a successful submission.
Yes, many regulatory agencies now accept electronic submissions in the CTD format. Electronic Common Technical Document (eCTD) is an electronic version of the CTD that allows for easier electronic submission and review.
Yes, the CTD format may undergo updates or revisions to align with changing regulatory requirements and advancements in pharmaceutical science. It’s important to stay informed about the latest guidelines.
Regulatory agencies benefit from the CTD format by receiving well-organized, standardized submissions that facilitate efficient review processes and better decision-making.
You can find comprehensive information about the CTD format, including guidelines and templates, on the official websites of regulatory agencies such as the FDA, EMA, and other relevant authorities.
Adopting the CTD format in pharmaceutical regulatory submissions contributes to a more streamlined and effective process, benefiting both pharmaceutical companies and regulatory agencies in ensuring the safety, quality, and efficacy of pharmaceutical products.
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