CTD – Common Technical Data for Medicines registration
The Common Technical Document (CTD) is a set of specifications for application dossier for the registration of Medicines and nowadays is used mainly in Europe, United States, Japan, Canada and Switzerland among others.
CTD entered into force in Europe and Japan in July 2003 and is the system that US FDA favours.
It was developed by the EMEA (European Medicines Agency), the US FDA (Food and Drug Administration) and the Ministry of Health, Labour and Welfare (Japan). The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
The Common Technical Document is divided into five modules
- Administrative and prescribing information. Module 1 is region specific.
- Overview and summary of modules 3 to 5. Modules 2 is common to all regions.
- Quality (pharmaceutical documentation). Modules 3 is common to all regions.
- Safety (toxicology studies). Modules 4 is common to all regions.
- Efficacy (clinical studies). Modules 5 is common to all regions.