Currently all new marketing authorization applications for medicinal products filed to Registration Agencies in Europe must be submitted in CTD format: Common Technical Document. eCTD is based on the CTD and allows registration dossiers to be submitted to regulatory authorities in electronic form.
The eCTD documentation is made up of 5 modules:
- Regional Administrative Information
- Common Technical Document Summaries
- Quality
- Nonclinical Study Reports
- Clinical Study Reports
There are two categories of modules:
- Regional Module 1 (different for each region; i.e., EU, USA, JP)
- Common Modules 2 – 5 (common to all regions).
Preparing a medicinal product’s dossier in eCTD format reduces the amount of time as well as the effort required in all phases of work with registration documentation.
