DADI: How Will New Updates Impact IDMP Preparations?

At the end of October, EMA started discussions with industry members regarding a change to their IDMP implementation approach. In addition to completing mandatory xEVMPD data submissions, organizations will now need to use a web-based application form called Digital Application Dataset Integration (DADI). Since its initial inception, EMA designed DADI as a long-term replacement for the electronic Application Form (eAF), which previously supported eCTD submissions. Initially, this form will be used to identify variations to existing products, and later releases will include coverage for both Initial Marketing Applications and Veterinary submissions and renewals.

DADI forms will include pre-populated Product Management Service (PMS) data, which will draw from SIAMED initially, followed eventually by other sources like xEVMPD. Applicants will also need to manually enter some fields and report any inconsistencies or errors that they find.

DADI messages can be added in PDF or fast healthcare interoperability resources (FHIR) format to the submission sequence, but users will not update the PMS database directly. This data will be used to support the EMA reviewer assessment process, ensuring that documents and data are consistent and aligned. Further guidance was issued in July 2022 concerning data model changes (Chapter 2), and some further examples provided (Chapter 8) in the current IDMP guidance, IG V2.1.1.

The use of DADI to collect data updates represents a smaller and more feasible first step for the industry, although EMA still intends to fully implement IDMP. We expect that this new DADI process will come into effect in October 2022 for variations to centrally approved products, followed by variations for products approved by other procedure types (MRP, DCP and National) in April 2023, becoming mandatory for all variations by October 2023, but remember that EMA will continue to handle all other submissions such as initial marketing authorisation applications, renewals, etc. as they have previously.

How can organizations prepare for these changes?

Applicants should continue to collect the necessary IDMP data and make sure their data and documents are always in sync, regardless of IDMP message formats and processes. EMA and other health authorities will increasingly demand data sets in addition to documents, so organizations should maintain high quality data and submissions in a single, unified system.

It’s also important to assess where source data currently resides, what systems and people are managing it, and how much control they have during the entire submission lifecycle. If data quality is poor, companies should make cleansing and enrichment activities a priority.

Putting in place a well-documented data governance model with agreed data quality principles will ensure that biopharma organizations are on the path to readiness. At the end of the day, they need full visibility into submission data and to make sure documents and data are fully aligned.