The web-based Digital Application Data Integration (DADI) project will replace the electronic Application Form (eAF) in 2022. DADI is intended to be used for CAPs and non-CAPs and will be pre-populated with product details from EMA’s PMS database.

This launch means that you, as a Marketing Authorization Holder, must have your data ready and under control. Ultimately, you need to define if you want to focus on compliance for DADI or to fully achieve benefits of structured data and setting you up for future IDMP compliance.

DADI is part of the SPOR program of EMA and is a first step in realization of the transition from documents to data.

DADI does not replace IDMP Iteration 1 implementation in the long-term, or XEVMPD in the short-term.

DADI impacts your application process. We recommend you take the following 8 steps to be ready for DADI implementation:

  1. Define focus: compliance or beyond
  2. Define DADI processes
  3. Create awareness
  4. Define Roles and Responsibilities and data governance
  5. Define DADI requirements
  6. Discuss with your technology vendor
  7. Define (RIM) data scope
  8. Perform data check with SPOR

See below for more information on the impact of DADI on your Processes, Organization, Technology and Information.

Timeline

This provisional timeline shows different milestones for DADI implementation and roll-out. Currently only the Human variations are planned and go-live is scheduled for October 2022. There will be a 6 month transition period for MAHs. That means in April 2023 DADI is mandatory for variations.

Preparation work will take place throughout 2023 for veterinary variations, initial MAAs, and renewals but the timelines for these to go-live are not yet scheduled

The Impact of DADI

The introduction of DADI doesn’t change the process of structured data:
➡️ Internal trigger (change control) ➡️ Dossier compilation ➡️ Submission ➡️ Validation / Assessment / Approval ➡️ XEVMPD

DADI is the EMA’s first step towards realizing the Target Operating Model and represents a significant change from the existing process. MAHs need to review their processes and evaluate the impact of DADI. , The introduction of DADI reconfirms the importance of aligning internal data – in your RIMS, XEVMPD and throughout your dossiers – with SPOR.

 

DADI impact on Processes

The impact of DADI on processes is mainly on the data flow. The EMA’s TOM (planned for implementation with IDMP) switches from a post-authorization to a pre-submission process. With the implementation of DADI, whilst xEVMPD continues to be maintained, you need both processes in place.

Even though EMA’s process doesn’t change, performing an assessment of the current eAF process is advised. This includes how interaction with the responsible person for xEVMPD/PMS is managed, together with emergency updates in xEVMPD, if data in xEVMPD is wrong for the eAF.

We identified 4 major process actions to take:

  1. Establishment of processes to align internal (RIM/MDM) data with SPOR
  2. Evaluation and establishment of a process that aligns data between sources eAF/DADI, XEVMPD, SmPC and Module 3.
  3. Update of the existing procedures and work instructions around the creation and updates of the eAFs
  4. Review and update of processes and interactions with local affiliates. DADI will be applicable for all EU regulatory procedures, instead of CP only/first, which will likely have an impact on the scope of your IDMP implementation projects.

 

DADI impact on Organization

The implementation of DADI has its impact on the organization.
It makes sense to continue to lay the foundations of your Data Governance in line with SPOR data elements. This will serve not only IDMP Iteration 1, but also DADI and future regulator implementations of IDMP. You need to decide whether to extend your data governance framework to include the DADI fields – and if you want to focus only on the static data elements or also look to standardize the transactional data elements.

Secondly, focus on Change Management. Keeping everyone well informed about the latest changes will be crucial to maintain program momentum. Inform all your stakeholders of the latest revisions to the plan and the impact on deliverables and timescales.

Training remains critical to ensure that everyone understands not just what’s changed in relation to IDMP Iteration 1, but also what the latest developments mean for the various stakeholders, their data and their processes.

The 2 major actions to take regarding organizational change are:

  1. Define clear Roles & Responsibilities with regards to the creation of eAF/DADI forms. The interaction of dataflows between systems (e.g. RIMS) and forms (e.g. DADI) and structured data submissions (e.g. DADI, XEVMPD) needs to be defined between regulatory headquarters and local affiliates.
  2. All involved stakeholders need to be aware of the new DADI data requirements and processes. A concrete data governance needs to be established to manage data quality for internal SPOR-data usage in addition to meeting submission requirements for DADI.

 

DADI impact on Technology

The introduction of DADI as data carrier of structured data to the authorities, without the possibility of an API, requires MAHs to review and define new technical requirements around the use of Technology. If you currently have capabilities that optimize your eAF creation, then you are now confronted by the loss of this functionality, until an API comes available to populate data directly in DADI or PMS.

With the development of DADI, you will need to review and define your requirements for capturing the data and aligning the processes.

If you haven’t done this already, we advise you to discuss this with your RIM vendor. Technical capabilities that are required in RIM systems regarding DADI are:

  1. Maintain the required xEVMPD data model, while also providing DADI (IDMP) data
  2. Versioning of data elements to track the submitted and approved status (e.g. parallel variations)
  3. Reporting requirements

For this reason, it is very important to define your RIM requirements and discuss these with your RIMS vendor. If you don’t have a RIMS yet, now is really the time!

 

DADI impact on Information

On 10th March 2022, EMA shared the presentation and the FHIR mapping and examples from the Digital Application Dataset Integration (DADI) Network Project Technical Webinar (FHIR) 25/01/2022.

One of the documents shared is an Excel with the “AF Data Requirements”, which provides the details of the data elements required for “variation” and “medicinal product”.

For many companies with an ongoing IDMP project, the alignment of PMS/IDMP with DADI has some serious implications.
As part of ongoing IDMP projects, companies were originally focused on an EU Iteration 1 IDMP data-set for Centralized Procedures (initial MAAs).

With the DADI go-live in October 2022, data from the entire EU portfolio (CAP and non-CAP) for variations are in scope. You will need to balance the need for data collection and the review of current processes and technical capabilities to define how DADI webforms will be populated.

Start with a quality check in xEVMPD vs RIMS and make sure all products are in xEVMPD – especially herbals/homeopathic products.

As a minimal requirement, you will need to guarantee the quality of the information for the entire EU portfolio – by April 2023, at the latest, on the following topics:

  • Medicinal product
  • Marketing Authorization
  • Packaged Medicinal Product
  • Ingredients

And we recommend you to get involved in DADI UAT in September.

 

Supporting you

Reach out to us, if you want to be DADI ready for the go-live in October 2022, so you will be compliant in April 2023.
We can support you with an assessment and implementation of DADI including clear steps on your specific Processes, Organization, Technology and Information.

For ongoing IDMP projects, the DADI plans do have impact on the scope and activities. Ultimately, MAHs need to make a decision on how to address DADI compliance and the fact that DADI also applies for Non-CAPs.

We can also help you with the incorporation of DADI into your existing IDMP projects with us and determine the implications and impact.

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