The European Medicines Agency has launched a pilot of electronic application forms
for submissions of centralised marketing authorisation applications yesterday.
for submissions of centralised marketing authorisation applications yesterday.
The pilot, which runs for four months until mid-July 2012, allows
pharmaceutical companies to apply for initial marketing authorisation
applications for human medicines, and variation and renewal applications for
human and veterinary medicines, using an interactive PDF form.
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:
(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.
.