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 may draw from xEVMPD submissions or other data sources like SIAMED. 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 can no longer 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. However, it's unclear how applicants will be notified after changes take place. We're also waiting on EMA to define the scope of these messages, but we anticipate that they will include additional ISO data points over and above what were outlined in the current IDMP guidance, IG V2.1.
This change represents a smaller and more feasible first step for the industry, although EMA still intends to fully implement IDMP in the near future. We expect that this new DADI process will come into effect during 2022, but remember that EMA will continue to handle all other submissions such as initial marketing authorization 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.
To learn more about how Veeva supports evolving regulations, visit the IDMP Readiness Center.
Veeva Systems Inc. published this content on 19 November 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 19 November 2021 18:23:08 UTC.