Electronic Application Forms (eAF) update

By 16. March 2016Blog

Since January 1st 2016, all Submissions to the European Union have to include electronic application forms instead of the previously used word templates. This initiative has been underway since January 2015 and is a joint initiative by Regulatory Authorities together with Industry representatives.

The official announcement can be reviewed here: Link to EMA

Since enforcement, the already well tested eAF forms have undergone a minor update that is available on the EMA website for download, with the following release notes:

Version 01.19.0.2 of the eAFs has been made available to fix technical issue related to the locking of the variation form and issues with the availability of the controlled terminologies in all forms. If you have already started to fill in version 1.19.0.1 of the variation form please import the user filled data to the new version to ensure that the form is fully locked. This can be done using the functionality to export the user filled data from 1.19.0.1 and import it into 1.19.0.2.

Version 1.19.0.1 will continue to be accepted for Renewal and Initial MAA Human and Vet applications, however you may wish to use the data import functionality to ensure optimum performance.

The goal of eAF is to simplify the ongoing transition from paper based submissions to full electronic communication between industry and regulators. Instead of only focusing of digitalization of existing format, EMA and local regulators are using the transition for major process optimizations. Electronic application forms play a significant role in this process, providing the industry with easier form filling capabilities based on standard terminology while standardized forms like these can be used by the regulators to develop semi-automated workflows that ensure the correct routing of submission to the necessary parties as well as process speed improvements.

Cunesoft started to support the eAF standard out of the box with its first official release in July 2015 and is currently working on increasing the support by creating automated generation functionalities based on the Cunesoft Regulatory Master Data Management System.

For further details and download of the related forms, please visit the EMA website at: http://esubmission.ema.europa.eu/eaf/

Daniel Koppers

Author Daniel Koppers

Cunesoft CTO, He has more than 7 years experience with software development and project management. Moreover, he has a deep knowledge of life sciences and regulated industries. His previous employers include Nextdocs and Adlib Software. He has a degree in business informatics.

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