In order to obtain a marketing authorisation, the applicant must submit a dossier to the regulatory authorities containing extensive technical data on the quality, safety and efficacy of the drug. This submission is supplemented with administrative documents such as application forms, declarations, labels and information leaflets.
Previously, despite requiring the same technical information, different national Regulatory Authorities had specified their own format for how the dossier should be assembled. To facilitate the review process, a common process was developed and accepted through the International Conference on Harmonisation (ICH). The Common Tehnical Document (CTD) was recommended for adoption by regulatory authorities in November 2000.
The CTD is organised into five modules
Module 1 is designed to contain region-specific information (e.g. application forms). This section is not harmonised and is not considered to be part of the CTD.
The other 4 Modules present technical data in a harmonised format. Module 2 contains a critical overview of the quality, non-clinical and clincal data, together with summaries of the non-clinical and clincal data. The objective of this section is to provide reviewers with an introduction to the submission, and to orient them as to how the applicant believes the data supports the granting of the marketing authorisation.
Modules 3, 4 and 5 provide the detailed qualtiy, non-clincal and clinical data,.
Module 4
Non-clinical study reports and references
CTD defines consistent order of reports and references but has no impact on content and format of individual reports
4.1 Table of Contents of Module 4
4.2 Study Reports
4.2.1 Pharmacology
4.2.2 Pharmacokinetics
4.2.3 Toxicology
4.3 Literature References
Module 5
Clinical pharmacology and clinical reports
CTD has no impact on format or content of individual reports
Data not to be included under some headings in particular regions, e.g.
CRFs not routinely submitted in EU
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
regaffairs.home.blog 