The pilot is a key step forward in the Agency's drive towards the use of electronic applications as standard, using the Electronic Common Technical Document (eCTD) format. This is expected to simplify and speed up the application process by:
- improving data quality and consistency;
- providing access to data in Extensible Markup Language (XML) format;
- integrating application data with controlled vocabulary lists.
The forms were developed by the European Medicines Agency, working together with the European Commission services and medicines regulatory authorities in European Union Member States.
Full details on how to register are available in the electronic application forms pilot guidance.