EMA Holds Final Round of Testing Before New Electronic Forms are Required

The European Medicines Agency (EMA) is conducting user-acceptance testing of new electronic application forms (eAF) in preparation for the transition to electronic-only applications on 1 July 2015.

Background

In February, EMA announced it would require all new human and veterinary medicines using the centralized procedure, including variations and renewals, to use eAFs as opposed to paper applications.

EMA began using electronic application forms for marketing authorization applications following a pilot launched in March 2012.

Currently, both paper and electronic application forms are accepted in the EU. However, in October 2014, the EU Telematics Management Board’s adopted the Heads of Medicines Agencies’ eSubmission Roadmap, which makes the case for transitioning to electronic-only application forms and lays out a timeline for the transition.

According to EMA, transitioning to new, PDF-based eAFs will provide numerous benefits, including:

"Removal of manual data extraction processes

Possibility to import data into databases

Higher data quality due to more structured data entry and usage of controlled terms

Built in business validation rules guide the applicants to fill in the forms correctly

Validation rules for the forms are in place and publicly available

Brings industry and [national competent authorities] toward a single application process”

Eventually, the goal of the eSubmissionRoadmap is to develop a single EU-wide submission portal that is fully integrated with the new eAFs by 2018.

User Testing

When EMA announced the transition to eAFs in February, the agency opened a user-acceptance testing period that ran until 5 March 2015.

Since then, EMA says the eAFs "have been significantly amended following feedback received," and that an updated version will be made available for the current round of testing.

Companies are invited to participate in the user-acceptance testing by contacting EMA to receive a test package. EMA requests companies that are part of trade associations provide their feedback directly to the association so feedback can be consolidated and submitted by the 8 June deadline. Additionally, national regulators are invited to participate and provide comment by 12 June.

EMA Press Release