EMA Announces Electronic Applications Pilot Program

The European Medicines Agency (EMA) has launched a pilot program for submitting centralized marketing authorization applications electronically. The pilot began on Mar. 12, 2012, and is expected to be active for four months. During this period, companies will be able 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.

In a press statement, EMA explained that the pilot is a step towards using electronic applications as standard, using the Electronic Common Technical Document (eCTD) format. Electronic applications are expected to simplify and accelerate the application process by improving data quality and consistency during data entry, providing access to data in XML format, and integrating application data with controlled terminology.

Depending on the success of the pilot, the PDF forms may become an alternative, as well as the recommended format for submitting eCTD applications to EMA. The forms were developed in collaboration with the EMA, European Commission services, and medicines regulators in European Union member states, and their content is identical to that of the current application forms published by the European Commission in EudraLex, Volume 2.

Companies wishing to participate in the pilot are being encouraged to register their interest so that they will receive any urgent updates. Details on how companies can take part are described in the EMA’s Electronic Application Forms Pilot Guidance.