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On July 28, 2022, the EMA released an incremental update to the IDMP-SPOR implementation guide (IG). The latest version, 2.1.1, addresses a few gaps in product data definition, including corrections and clarifications.
The new version enables web-based forms to replace the existing electronic application forms (eAF), making them more efficient. The web-based forms project is called DADI (Digital Application Dataset Integration), and its implementation is planned to start in October 2022 with an initial web form for variation procedures only.
Whilst this IG update is limited in terms of new data elements in scope, it does set out methods from the EMA for migrating centrally authorized product data from their internal corporate system (known as SIAMED2) to the emerging SPOR-PMS (Product Management Service). Previous versions of the IG covered the migration of the pharmacovigilance product database (xEVMPD) to PMS.
Several additional attributes are identified in IG v2.1.1, the majority of which are related to medical devices, e.g., device descriptions. Other changes to attributes expand on definitions for existing data elements related to manufacturers. It will help to align product data with the eAF replacement – DADI. Additional information is also included that covers the special post-Brexit case of submitting information about medicinal products authorized in Northern Ireland (XI).
The updated IG also includes comprehensive working examples of product data definitions compliant with the latest data element changes and further help in the practical illustration of defining product data for PMS.
Clear definitions of Mandatory, Conditional, and Optional for some data fields, new RMS lists with updated existing lists, and updated FHIR paths for data elements are stated as well.
At the time that DADI go-live, only 15 fields from PMS will be fully populated and made available for use, of which 12 are sourced from SIAMED2.
In the second DADI release, CAP and non-CAP data from xEVMPD will be migrated and incorporated into the PMS data model. A match-and-merge will occur during the migration of CAP data from SIAMED2 and xEVMPD, whereas for non-CAPs, data will only be migrated from xEVMPD.
The conformances of expression of strength in patterns 2b, 3a, and 3b were modified in chapter 8. The manufactured item quantity value has also been updated.
Recommendations
Given the scope of changes in the latest implementation guide, the recommendations remain relatively low impact. DADI’s implementation is expected to start in a limited fashion for CAPs from October 2022. Once the EMA has completed its initial data migration from SIAMED2 to PMS, there may be a requirement to re-confirm the Regulatory definition of medicinal product data. Existing data collection activities should be reviewed to ensure that the new and updated data elements comply with EU IG v 2.1.1. Firms with integrated Regulatory Information Management platforms and submission tools must check and confirm that the required support is available from their platform vendors.
The Essential link between IDMP and Data Governance
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