Regulatory Dossier and Its Contents

A regulatory dossier is a package of documents, which may include all required information regarding newly developed drug products and/or generics. The main information included in the package is administrative information, safety, efficacy and quality data of drug product.

CTD (Common Technical Document)

Presently there are four ICH guidelines on the CTD (M4, M4Q, M4S, and M4E), along with four question and answer documents. Let’s take look at different modules:

The CTD dossier is divided into five main modules

Module 1 – Administrative information and prescribing information:
Module 1 describes the administrative and prescribing information. It should contain documents that are specific to each region; for example, application forms or the proposed label for use in the region.

Module 2 - Overviews and summaries:
The Module provides an overall summary of the ‘quality’ formation, as well as the non-clinical overview and the clinical overview, the non-clinical written summaries and the tabulated summaries, and the clinical summary. Module 2 contains seven sections that should be maintained in the following order:

2.1 Table of contents
2.2 Introduction
2.3 Quality Overall Summary
2.4 Non-clinical Overview
2.5 Clinical Overview
2.6 Non-clinical Written and Tabulated Summaries
2.7 Clinical Summary.

Module 3 – Quality (pharmaceutical documentation):
Module 3 presents the chemistry, manufacturing, and controls reports for the product included in the registration dossier. The main sections in this module are:
3.1 Table of contents
3.2 Body of data
3.2.S Drug Substance
3.2.P Drug Product
3.3 Literature references used in Module 3

Module 4: Non-clinical reports (pharmacology/toxicology):
Module 4 presents the non-clinical reports included in the dossier. These study reports are prepared based on the careful evaluation of the proposed drug's pharmacologic, pharmacokinetic, and toxicological effects, and are presented and discussed very extensively. The section includes:
4.1 Table of contents
4.2 Study reports
4.2.1 Pharmacology
4.2.2 Pharmacokinetics
4.2.3 Toxicology
4.3 Literature references used in Module 4.

Module 5: Clinical study reports (clinical trials):
Module 5 contains the raw data of the clinical study reports on the efficacy of the drug in length, with a particular focus on the benefit-risk aspect of the drug. The module includes:
5.1 Table of contents
5.2 List of all clinical studies
5.3 Clinical study reports
5.3.1 Reports of biopharmaceutic studies
5.3.2 Reports of studies pertinent to PK using human biomaterials
5.3.3 Reports of human PK studies
5.3.4 Reports of human PD studies
5.3.5 Reports of efficacy and safety studies
5.3.6 Reports of post-marketing experience
5.3.7 Case report forms and individual patient listings
5.4 References

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