The EMA eAF electronic application for Variation Forms went live for Centralised Authorised Products on November 4. This is a first major step forward in the effort to digitalise business and the way medicinal products data are handled by regulatory authorities. This enables to digitally process medicinal product and procedure data and facilitates consistency in IT systems including common data repository and is part of a digital business transformation process as set up by the EMA HMA Strategy 2025.

UNICOM together with EMA want to keep up the pace and is now starting to work on Marketing Authorization Applications (eAF MAA)! The preparation work related to the electronic application of eAF MAA has just started: 7 National Competent Authorities active within UNICOM have met in Brussels on November 29 and have together discussed both the vision and strategic cornerstones.

They also discussed the much-needed alignment with the progress of SPOR and PMS (Product Management System) in particular.

All present NCAs representatives confirmed they intend to use the available data of eAF MAA to electronically directly populate national and common Product Management IT Systems and PMS to have high quality structured data according to IDMP for further regulatory work and additional business cases on the horizon.

2023 will thus need to be an acceleration year for all European National Competent Authorities and UNICOM will make sure to involve as much as possible all European NCAs not active in the consortium in order to make sure all European Agencies take the necessary urgent steps to be part of this journey.