The document describes how to organize applications based on the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines on the CTD. The CTD is currently only applicable to human, not veterinary, medicines.
This guideline describes the following points;
- Module 1 – Administrative information and prescribing information
- Module 2 – Summary of the dossier
- Module 3 – Quality
- Module 4 – Non-clinical study reports
- Module 5 – Clinical study reports
- European Union guidelines on quality, safety, and efficacy