Whitepaper: FHIR in eCTD - SPOR - DADI - ePI: A new Age begins.

Highlighting the technical aspects across all 4 initiatives.

The IDMP standard from the ISO is a great step towards patient safety and security. The European implementation of IDMP – called SPOR – focuses on better communication between industry and agencies, improving regulatory processes overall. Together with the approach to unify the message standard (FHIR) in all 4 initiatives (SPOR, eCTD, DADI and ePI) it promotes a more streamlined and secure step towards an exceptional future for the life sciences sector.

In this whitepaper we highlight the possibilities and challenges that will emerge across all 4 initiatives. Each has its own complexity and bringing them all together may initially cause confusion for organizations. This whitepaper aims to help you achieve your first steps into a new regulatory world with the potential for harmonized, international patient safety.


By Dr. Anna Thaidigsman and Dr. Gerhard Neurauter