Goodbye to pdf forms

• Variations
• Initial marketing authorization applications
• Renewals (human)
• Other submissions are under consideration, human and veterinary forms centrally authorized product (CAPs) and nationally authorized product (NAPs) applications

DADI Project Timeline (version August 2021)

Aim of DADI Project

The aim of the DADI project is to make electronic application form (eAF) completion and submission to authorities more efficient[iv].

To achieve this goal, the following steps will need to be achieved:

• Replace current PDF-file based input eAFs with web forms on an updated portal.
• Completing the forms produces both the familiar human-readable (.pdf) output and a new machine-readable output for digital processing (FHIR data exchange standard for medicinal products – more about FHIR below).
• Structure input of eAFs to capture standard product data (Product Management Services, PMS), ensuring ISO IDMP compliance. Reuse PMS data to prepopulate application inputs wherever relevant.
• Integration of the forms with improved processes for handling CAPs submissions, reducing manual processing, errors, and processing time.

The advantages EMA is hoping to get out of this digital transformation are quite generic and high-level (better decision-making using AI, transformation of processes etc.)

But of course, any digitalization EMA is aiming to achieve, is very welcome.

Background to the DADI Project

The plans for eAF in June 2019 (vii)

System Description

• Consists of subject matter experts representing EMA, NCAs and the pharmaceutical industry
• Provides expert insight into the use of forms
• Supports testing of the forms

What will change technically in the forms?

The main thing is, of course, that the applicants fill out a web form instead of the interactive PDF form. Anyone who has used the current .pdf version of eAF knows that at best the form filling is slow. At worst, you might be facing a long list of problems in addition to the slow repetitive work.

The output is currently a filled in .pdf form which is included in the electronic Common Technical Document (eCTD) / VNeeS package which is submitted to the regulators. After the implementation of the electronic forms, the output will include both the same human readable .pdf form and, in addition, a machine readable HL7 FHIR message which can be read and processed by IT systems[viii].

Comparison of current eAF process to the process after DADI

So, the main thing is the update of the input and the new FHIR document that can be further used in other systems of the authorities. For the pharmaceutical companies, the update should bring at least slightly faster and easier submission of variations, applications, and renewals (especially if the pre-population of fields and connection to SPOR elements work as planned). To the authorities this upgrade should give possibilities to automate and integrate and, to achieve the hoped for standardization of data.

How will the project impact industry stakeholders?

There are a set of features that are going to be implemented at one point or the other during the DADI project. These include for example the collection and use of standardized PMS/UPD (Union Product Database) product master data, pre-populating fields with available PMS/UPD data and industry having full visibility of data available on the regulator’s side.

The variations form will soon be in use, and the list of features have been made available[ix]. The list includes for example:

• Organization Search (connected to OMS)
• Product Selection (connected to IRIS and PMS)
• Including proof of payment
• Contextual guidelines for sections and fields and form validation
• Possibility to copy / duplicate application
• Tracked changes

Once the variation web form moves to testing and later, release and implementation a more detailed breakdown of possible impacts for industry will be made available.

In later releases, the aim is to eventually integrate eAF and data submission on authorized medicines (XEVMPD / Article 57 data) submissions into a single process. This would reduce unnecessary administrative burden and would improve the product data quality overall.

How will the DADI project impact NCAs?

• Mutual Recognition Procedure (MRP)
• Decentralized Procedure (DCP)
• National Procedure (NP)
• Subsequent Recognition Procedure (SRP) for veterinary

What is the connection between SPOR and DADI?

• Increased data quality and simplification of data management practices, since data will be reviewed, assessed and approved as part of the new data operating model
• More efficient regulatory action and decision-making, thanks to improved data integrity and reliability
• Regulatory requirements can be met more effectively, by reducing data silos and improving interoperability across EU systems
• Operational savings and efficiencies can be achieved, as pharmaceutical companies need to supply regulatory data only once, which will be reused across different procedures and regulators.

What is FHIR?

• The DADI project team creates a FHIR specification as the backbone of the new online form.
• FHIR aims to simplify implementation without sacrificing information integrity. It leverages existing logical and theoretical models to provide a consistent, easy to implement, and rigorous mechanism for exchanging data between healthcare applications.
• The basic building block in FHIR is a “Resource”. All exchangeable content is defined as a resource that contains a common way to define and represent them, a common set of metadata and a human readable part.

What’s the next step?

Resources