EMA’s webinar “DADI-PMS Webinar Agenda – ‘Variations Form for Human Medicinal Products – What will happen at Go-Live’” made it more than clear: data quality [in PMS] is dependent on xEVMPD.
In our previous blog on PMS Data Migration we highlighted some of the challenges faced by Marketing Authorisation Holders (MAHs) already and these challenges remain. In fact, I believe these challenges became more obvious during the EMA (European Medicine Agency) webinar. xEVMPD (Extended EudraVigilance Medicinal Product Dictionary) data still needs to be submitted, allowing PMS (Product Management Service) updates to happen. In case of inconsistent or even incorrect xEVMPD data, PMS data would also be incorrect. As PMS feeds into other systems, the chain of data reuse highlights the importance of data quality.
What about the eAF and DADI?
The electronic Application Form (eAF) already makes use of SPOR, connecting data fields with the data held by the EMA. With the introduction of DADI (Digital Application Dataset Integration), in a step by step process more and more free text fields will be replaced with dropdown lists to increase data consistency and quality. However, some of these fields will also be fed from PMS and hence indirectly from xEVMPD. Although the output format from DADI will still be PDF, the file itself will already contain information in the new FHIR (Fast Healthcare Interoperability Resources) format. Another reason for keeping the xEVMPD data accurate, clean and consistent.
What are the challenges?
Considerable effort has been made to implement SPOR using an Agile approach by the EMA with all its benefits and drawbacks. A step by step release of SPOR allows all parties to align their processes and procedures early and make use of Organisations and Referentials already. With the PMS data migration ongoing, not all medicinal products are available from day one and hence not all MAHs will benefit. However, the Agile release approach allows a step by step introduction of PMS. There is also a question about products that currently are not on the xEVMPD database such as herbal medicines or homeopathic products. Clear guidance on the best way forward to handle these in PMS will be required.
The recent EMA webinar on DADI clearly highlighted the benefits of getting xEVMPD data up to date, clean, and consistent before any data migration to PMS takes place. Otherwise, any inconsistent or incorrect data will be migrated and will feed other systems and processes such as DADI or the eAF. Afterall, it is the responsibility of MAHs to keep their data correct and up to date.