1. International Council on Harmonisation (ICH)
1.2. ICH Common Technical Document (CTD)
Most of the ICH guidelines contain information for industry on what documentation to provide in a MA application. This helps industry to reduce duplication of work. For example, without harmonised guidelines relating to ‘efficacy’, extra burden would be on companies. They might need to perform extra clinical trials to comply with the different requirements in different regions.
The format of the dossier submitted for a MA is also important. It is helpful for everybody involved if dossiers for different regions can be structured in a similar way. In 2000, the ICH published a very important guideline in this area, the ‘Common Technical Document’, known as the CTD.
CTD Triangle
The CTD Triangle. The Common Technical Document is organized into five modules. Module 1 is region specific and modules 2,3,4 and 5 are intended to be common for all regions. Source: www.ich.org
Figure 1: The CTD Triangle showing the content of
the CTD.
The CTD describes in detail how a dossier for a MA application shall be collected and structured. A description of the content appears in Figure 3 above. The file for an MA application consists of five modules. The triangle illustrates that the broader the section, the larger the amount of documentation required.
Modules 3, 4 and 5 (widest row of the triangle) - contain the full and detailed documentation covering quality, safety and efficacy. For a new innovative medicine, this may well be 200,000 A4 pages or more.
Module 2 (middle row of the triangle) - as Modules 3, 4 and 5 are so lengthy - summaries have to be included to improve the readability of the dossier.
These summaries form Module 2:
- For quality, one summary document is sufficient – an overall summary.
- A two-level approach is needed for non-clinical and clinical - both having a summary and an overview. The summary documents mentioned may be up to a few hundred pages. The overview documents are condensed versions of typically 30 pages.
Module 1 (narrowest row of the triangle) - this is not harmonised between regions. Each region has to elaborate (develop) its own Module 1. The application form and proposed labelling are amongst the elements of this module.
The structure of the CTD makes it more convenient for the experts assessing the dossier. They will normally start with the overviews and summaries to get a broad picture of the documentation on the new medicine. After that, they can dig deeper into the detailed documentation whenever needed to fully understand and evaluate the dossier.