12 March 2012

European Medicines Agency (EMA) launches electronic application form pilot for CP Submissions

The European Medicines Agency has launched a pilot of electronic application form for submissions of centralized marketing authorization applications on Monday (12th March 2012).

The pilot, which runs for four months until mid-July 2012, allows pharmaceutical companies to apply for initial marketing authorization 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 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.

To find more information please click here


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