A Study about the regulatory dossier and CTD

The Uniform Technical Document (CTD) was developed to provide a common format for technical content in a registration application for a human pharmaceutical product in Europe, the United States, and Japan. The CTD dossier is divided into five sections:

Module 1 – Administrative and suggestion data;

Module 2 – Overviews and details of Modules 3-5;

Module 3 – Non-clinical reports (pharmacology/toxicology); and

Module 4 – Quality assurance (pharmaceutical documentation)

Module 5 – Clinical trial reports (clinical trials). Detailed criteria describing the content of each Module are provided, and the bulk of submissions must now adhere to the CTD format for submission dossiers.

The overall organization of the CTD

The ICH M4 guidelines1 outline the CTD’s overall structure, which includes a granularity section that provides advice on document placement and pagination inside the CTD dossier. This granularity information is especially important if the dossier contains many indications or components of the investigational medicinal product (IMP). Aside from the M4 requirements, questions and answers are provided to address the most often mentioned issues.

Although CTD development was mostly successful, and all dossiers now use the CTD format (with newer dossiers moving to the eCTD format), several regions still have some of their old pre-CTD dossier requirements. The most common example is the FDA’s need in the USA application for an Integrated Summary of Efficacy (ISE) and an Integrated Summary of Safety (ISS), despite the Clinical Summary being designed to replace both. As a result, the recommendation included in Module 5 incorporates the whole ISE and ISS and then compresses this into a summary style for the Module.

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