Conclusion and Outlook to the Application Form (eAF) as a Vehicle for IDMP Data Submissions
Both EMA as well as FDA obviously have chosen a pragmatic approach to introduce the concepts, identifiers and systems from the IDMP standards.
The eAF with embedded SPOR-OMS data is seen as a paradigm for further structured data to be included in electronic application forms. There are significant benefits expected from this which all result from the opportunity to reuse the structured data for a number of use cases.
This will bring significant benefits for the pharmaceutical company, the health authority, and, last, but not least, the patient.
Link to EMA´s Publication giving more Details on the Application Form (eAF) as a Vehicle for IDMP Data Submissions
EMA´s SPOR Webinar on Using OMS and RMS in eAF (as of 28.11.2017)
 Pharmaceutical Quality/ Chemistry Manufacturing and Controls (PQ/CMC) Data Elements and Terminologies, círculated by the FDA in August 2017 for annotation and review
IDMP1 will be present at the upcoming Regulatory Submissions, Information and Document Management Form (RSIDM), at North Bethesda, from February 5-7, 2018. If you are there, too, don’t forget to visit us at the booth (no. 212) of our partner IDENTIFICA.
 SPOR-OMS: Organisation management system component
 SPOR – RMS: Referentials management system component
 European Federation of Pharmaceutical Industries and Associations