The EU Digital Application Dataset Integration (DADI) project on web-based regulatory application forms

Last updated: 30 May 2024

See history of updates below.

The EU Digital Application Dataset Integration (DADI) project on web-based regulatory application forms is currently in progress.

This project will have a wide ranging and positive impact on industry stakeholders and regulatory agencies in the EU. At its core is a drive to increase efficiencies at many levels by replacing the currently used electronic Application Forms for EU regulatory applications, with web-based forms.

Whilst both human and veterinary medicinal products are covered in the DADI project, only human medicinal products are covered in this post.

Click on the ‘+’ sign next to each heading to access the information under each heading.

DateUpdate
30 May 20241) In the section Product Lifecycle Management (PLM) Portal, the link in point no 2 to the Lifecycle Management Portal -Human variations eAF guide to Registration has been updated to Draft 1.3 16 May 2024.

2) In the section Where can you find further information on the DADI project?, the table has been updated to include a link to the webinar from 7 May 2024, plus the presentation and Q&As.

3) The table in the section What is the delivery timeline of the variation web form(s)? has been updated entirely.
28 Feb 2024Links updated in the section Q&A documents.
5 Feb 2023In the section Product Lifecycle Management (PLM) Portal:
– Information concerning point No 5 (PLM Portal eAF Release notes) was updated.
– point no 6 on PLM Portal eAF FHIR XML Release notes was added.
13 Nov 2023Table in section entitled Where can you find further information on the DADI project? updated to add a link to the following webinar:
Update on Human Variations web based eAF implementation on PLM Portal (6 Nov 2023)
14 Aug 2023In the section Product Lifecycle Management (PLM) Portal, point no 5 has been updated to reflect the updated PLM Portal eAF release notes  released to production on the 07 of August 2023.
1 Aug 2023In the section Product Lifecycle Management (PLM) Portal, point no 5 has been updated to reflect the updated PLM Portal eAF release notes.
15 Jul 2023Section What is the delivery timeline of the variation web form(s)? updated based on updated target delivery timeline provided on the eSubmission website.
12 Jul 2023Table in section entitled Where can you find further information on the DADI project? updated to add a link to the following webinar:
eAF-PMS Q&A Clinic – Session 2 (22 June 2023)
26 Jun 20231) Table in section entitled Where can you find further information on the DADI project? updated to add a link to the following webinar:
eAF-PMS Q&A Clinic – Session 1 (15 June 2023)

2) In the section Product Lifecycle Management (PLM) Portal, link provided (point no 5) to PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.0.1.9 released to production on the 12 of June 2023.
28 May 2023
1) In the section entitled Product Lifecycle Management (PLM) Portal, the details for Item no 5, PLM Portal eAF Release notes has been updated to version 1.0.1.8 released to production on 16 May 2023.

2) The section entitled DADI eAF Project and PMS joint Q&A document has been renamed to Q&A Documents and links added to the following documents:
i. Human Variations eAF-PMS Frequently Asked Questions (FAQs) Document of March 2023
ii. eAF (DADI)-PMS joint Q&A document Version 5 of May 2023.
4 May 2023Section entitled What is the delivery timeline of the variation web form(s)? updated (from information available on the esubmissions website) to present the new delivery timeline of web-based human
variation eAFs.
23 Mar 2023Table in section entitled Where can you find further information on the DADI project? updated to add a link to the following webinar:

Quarterly System Demo Q1 2023 22 Mar 2023
25 Feb 2023Table in section entitled Where can you find further information on the DADI project? updated to add a link to the following webinars:

eAF Q&A Clinica#4 -14 Dec 2022
eAF Q&A Clinica#6 – 24 Jan 2023
eAF Q&A Clinica#7 – 17 Jan 2023
24 Feb 2023In the section Product Lifecycle Management Portal link no 5 (PLM Portal eAF Release notes) has been updated to reflect the version of 21 February 2023.
14 Feb 20231) Table in section entitled Where can you find further information on the DADI project? updated to add a link to the webinar of 2 February 2023 entitled eAF Human Variations training

2) Section entitled DADI eAF portal guide to registration removed and contents added to the section Product Lifecycle Management (PLM) Portal.
12 Feb 20231) Added new section entitled Product Lifecycle Management (PLM) Portal plus relevant content.

2) Added new section entitled DADI eAF Project and PMS joint Q&A document plus relevant content.

3) Made administrative changes to the section Where can you find further information on the DADI project? to improve readability and suability. Wherever available, a link has also been provided to the Q&A document from the webinar.
7 Feb 2023Table in section entitled Where can you find further information on the DADI project? updated to add a link to the webinar of 15 December 2022 entitled Human Variations eAF training
4 Feb 2023Table in section entitled Where can you find further information on the DADI project? updated to add a link to the webinar of 19 December 2022 entitled Human Variations eAF Q&A clinic #5
16 Jan 2023Table in section entitled Where can you find further information on the DADI project? updated to add a link to the webinar of 29 November 2022 entitled Human variations eAF Q & A clinic #3
12 Jan 2023Table in section entitled Where can you find further information on the DADI project? updated to add a link to the webinar of 22 November 2022 entitled Human Variations eAF Q&A Clinic #1. prj221122 Human variations eAF Q&A Clinic #2
22 Dec 2022The following updates were made:

1) Section entitled What is the delivery timeline of the variation web form(s)? updated to provide latest timelines.

2) Table in section entitled Where can you find further information on the DADI project? updated to add a link to the webinar of 21 December 2022 entitled EMA System Demo Q4-2022

3) Section entitled DADI eAF portal guide to registration updated to provide a link to the latest version of the portal guide to registration dated 18 December 2022.
21 Dec 2022Table in section entitled Where can you find further information on the DADI project? updated to add a link to the webinar of 15 November 2022 entitled Human Variations eAF Q&A Clinic #1.
20 Dec 20222The following updates were made:
1) Section entitled What is the delivery timeline of the variation web form(s)? updated to provide latest timelines.

2) Section entitled DADI eAF portal guide to registration updated to provide a link to the latest version of the portal guide to registration dated 14 November 2022.

3) Section entitled Training sessions and Q&A clinics updated to provide a link to the page where you can find details about the latest training sessions.

Further training videos are available on this page.

Before launching into the DADI project, it is important to have a basic understanding of the following terms.

ISO IDMP

The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organisation for Standardisation (ISO) for the identification of medicinal products (IDMP).

EMA is implementing the standards in a phased programme based on the four domains of master data in pharmaceutical regulatory processes: substance, product, organisation and referential (SPOR) master data.

The ISO IDMP standards specify the use of standardised definitions for the identification and description of medicinal products for human use.

Their purpose is to facilitate the reliable exchange of medicinal product information in a robust and consistent manner.

They help to ensure wide interoperability across global regulatory and healthcare communities, which is critical in ensuring accurate analysis and unambiguous communication across jurisdictions.

Commission Implementing Regulation (EU) No 520/2012 (Articles 25 and 26) obliges European Union (EU) Member States, marketing authorisation holders and EMA to make use of the ISO IDMP standards. This will impact on many areas of the pharmaceutical regulatory environment, both in the EU and other regions.

ISO IDMP comprises five separate standards. These standards establish definitions and concepts and describe data elements and their structural relationships. They cover the following aspects to describe a medicinal product:

  • Medicinal product name
  • Ingredient substances
  • Pharmaceutical product (route of administration, strength)
  • Marketing Authorisation
  • Clinical particulars
  • Packaging
  • Manufacturing.

ISO IDMP covers the entire medicinal product lifecycle, including products in development, investigational products, products under evaluation and authorised products.

Although ISO IDMP standards relate to human medicinal products, SPOR applies to both human and veterinary domains.

What are the benefits of using ISO IDMP in the Regulatory Context

Using ISO IDMP within regulatory activities will bring benefits to regulators, industry and ultimately patients. It will do this by:

  • Facilitating the identification and exchange of product and substance information globally, across regulators
  • Improving data integrity and reliability
  • Enabling reuse of data across different procedures and regulators
  • Reducing silos and improving interoperability across EU systems through the optimisation and simplification of data operating models and data management practices
  • Streamlining, optimising and simplifying regulatory processes to fulfil regulatory requirements more efficiently
  • Speeding up decision-making and improving communication with the stakeholders through easily accessible and highly reliable data.
SPOR

The ISO IDMP standards will be implemented in phases, through a set of projects known as SPOR data management services (Substances, Products, Organisations, Referentials). They will establish ISO IDMP compliant business services for the central management of data in each of the four SPOR areas. The four SPOR services cover the four domains of SPOR master data:

  • Substance Management Service (SMS) – harmonised data and definitions to uniquely identify the ingredients and materials that constitute a medicinal product;
  • Product Management Service (PMS) – harmonised data and definitions to uniquely identify a medicinal product based on regulated information (e.g. marketing authorisation, packaging and medicinal information);
  • Organisation Management Service (OMS)– data comprising organisation name and location address, for organisations such as marketing authorisation holders, sponsors, regulatory authorities and manufacturers;
  • Referentials Management Service (RMS)– lists of terms (controlled vocabularies) to describe attributes of products, e.g. lists of dosage forms, units of measurement and routes of administration.

You can read more about ISO IDMP and SPOR in this document entitled Introduction to ISO Identification of Medicinal Products, SPOR programme. Further information is available on the EMA website, here. You can also view a webinar on the process to request access to the SPOR API, here.

FHIR
  • Fast Healthcare Interoperability Resources (FHIR) is a standard for exchanging healthcare information electronically.
  • The DADI project team will create a FHIR specification as backbone for each of the new web-based forms.
  • FHIR is the machine-readable language chosen to support the easy exchange of data between DADI’s forms, systems and product databases such as Product Management Service (PMS)
  • 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. Resources all share the following set of characteristics:
    • A common way to define and represent them, building them from data types that define common reusable patterns of elements
    • A common set of metadata
    • A human readable part

This presentation from Intersystems is useful in helping to better understand FHIR. This short clip should help you to understand what an API is.

The main aim of the DADI Project is to replace current PDF-based electronic application forms (eAFs) for key EU regulatory procedures, with new web-based forms via a new electronic Application Forms (eAF) portal.

The goals of the DADI project are to:

  • Replace current PDF-file based input eAFs with web-based forms on an updated portal.
  • Enable both the familiar human-readable (PDF) output and a new machine-readable output for digital processing (FHIR data exchange standard for medicinal products).
  • Structure input of eAFs to capture standard product data (PMS), ensuring ISO IDMP compliance.
  • Reuse (PMS) data to pre-populate application inputs wherever relevant.
  • EMA will integrate the forms with improved processes for handling Centrally Authorised Products (CAPs) submissions, reducing manual processing, errors and processing time.

The DADI web-based forms are a means to enable more efficient application processing, reducing the administrative burden.

The new web-based forms will:

  • standardise input for eAFs in order to effectively provide standard product master data for human and veterinary medicinal products.
  • enable both the familiar human-readable (PDF) output and a new machine-readable output for digital processing based on the FHIR data exchange standard for medicinal products.
  • also use available product master data from Product Management Services (PMS) for human medicinal products to pre-populate form fields where relevant.

The expected benefits of the web-base forms include the following:

  • support validation of applications by competent authorities, reducing errors and discrepancies.
  • facilitate the feeding of “first-time-right” into databases, making interoperability of systems and sharing of data between competent authorities much easier
  • replacing aging technology that is no longer fit for purpose
  • enabling progressive usability improvements for users over the current PDF input forms such as:
    • upon release, the new forms will help applicants’ form filling by using available PMS data to pre-populate form fields where relevant
    • The use of master data will for instance also mean that drop down lists in the form will have fewer duplicate or similar entries, reducing their length and making them easier and quicker to use.
  • User-friendliness will improve over time as all the standardised Product and Substance Management Service databases become available, for example:
    • substances drop down lists will take much shorter time to load and will have less duplicate or confusing entries

The licensing routes supported web-based forms will be the following:

  • centrally authorised product (CAP) applications and
  • applications routes leading to nationally authorised products (NAP)

The project will replace forms used for the following key EU procedures:

  • centralised procedure (CP)
  • mutual recognition procedure (MRP)
  • decentralised procedure (DCP)
  • national procedures (NP)

Additional procedures will also be considered in the project.

For the above procedure types, the applications impacted will be the following:

  • Initial Marketing Authorisation Applications
  • Variations
  • Renewals

Other applications types are also under consideration.

No, the DADI project will not change:

  • the process to apply for or submit the Marketing authorisation applications.
  • the format of the current PDF output
  • the content of the of output form included in the application.
TimelineActionNotes
Q1 2024• Delivery of eAF features developed in Q4 2023 • -• Consolidation of development activities for PLM Portal product under one service providerSource of information in this table is the website eSubmissions and the Key steps and milestones document.
Q2 2024• Step 1: Release of all CAPs & NAPs in PMS database & updated* CAPs in eAF
• Step 2:Delivery of PMS API (CAPs and NAPs view-only) and Product UI (CAPs view-only)
As announced in May 2024 at the webinar “Information and Q&A session on updated CAPs in web-based eAF” (recording & presentation available), the load of updated* Centrally Authorised Products (CAPs) data to PLM Portal web-based eAF was completed on 19 April 2024. Users can now access this new CAP product data directly within the web-based forms.

The use of the PLM Portal web-based eAF for all CAPs variations is recommended starting from 14 May 2024. However, please be aware that there are still some known issues and limitations that actively being addressed. However, these issues do not prevent the use of the web-based eAF. You to consult the 7 May webinar presentation (at link above) for the complete list of known issues.
Q2 to Q4 2024:Performance improvements and internal testing
Q4 2024: NAPs release in eAF and Product UI, provided performance improvements are done
  • The current PDF-file based input form will be replaced by a web-based input form for CAPs and NAPs applications.
  • All new web-based application form will be pre-populated with available PMS data. Industry will have full visibility of data available on the regulator’s side.
  • The forms will support the collection and use of standardised PMS product master data. The forms are a key component for the target operating model designed for regulators and industry to reap the benefits of PMS in the future.
  • DADI is currently developing the variations form. Once this moves to testing and later, release and implementation a more detailed breakdown of possible impacts for industry will be made available.
  • The aim is to eventually integrate eAF and Data submission on authorised medicines (Article 57) submissions into a single process – the Product Management Service Target Operating Model. This will facilitate greater efficiency, and better data quality overall. This will not be part of the initial releases of the forms.

The web-based application forms will be common for both Nationally Authorised Products (NAPs) as well as Centrally authorised Products (CAPs) which are processed by National Competent Authorities (NCAs) and EMA respectively.

Competent authorities currently using the PDF forms’ XML functionalities will need to adjust their systems to accommodate the new FHIR compliant XML

Competent authorities which are not currently using the PDF forms’ XML functionalities will notice little change – the PDF output of the web-based form may look a little different.

Further detailed information is available on the eSubmission website here.

Of the information provided on the eSubmission website, the document entitled DADI eAF Project and PMS joint Q&A document Digital Application Dataset Integration (DADI) Network Project and Product Management Service (PMS) Questions and Answers is helpful in helping to understand more about the project. The latest version is version 4 of September 2022. You can view it here. The document will be updated on an ongoing basis.

Links are provided below to presentations and webinars from the EMA:

DateItemTitle (click on the link(s))
7 May 2024WebinarUpdated CAPs in web-based eAF information and Q&A session

You can also view the presentation and Q&As from the webinar.

Source: EMA
6 Nov 2023WebinarUpdate on Human variations web based eAF implementation on PLM portal
22 Jun 2023Webinar eAF-PMS Q&A Clinic – Session 2
15 Jun 2023WebinareAF-PMS Q&A Clinic – Session 1
22 Mar 2023Webinar Quarterly System Demo – Q1 2023
24 Jan 2023Webinar eAF Q&A clinic#7
2 Feb 2023WebinareAF Human Variations Training
17 Jan 2023WebinareAF Q&A clinic#6
December 2022NewslettereAF Newsletter
21 Dec 2022WebinarEMA System Demo Q4-2022 which includes
information on the eAF Human variation form
19 Dec 2022WebinarHuman Variations eAF Q&A Clinic #5
15 Dec 2022WebinarHuman Variations eAF training
14 Dec 2022WebinareAF Q&A Clinic#4
29 Nov 2022 WebinarHuman variations eAF Q & A clinic #3
22 Nov 2022Webinarprj221122 Human variations eAF Q&A Clinic #2
15 Nov 2022WebinarHuman Variations eAF Q&A Clinic #1
8 Nov 2022Webinar and Q&A documentHuman variations eAF (DADI) training session

Q&A Document
27 Oct 2022Webinar and Q& A document
Human variations eAF (DADI) go-live Q&A session

Q&A document
28 Sept 2022WebinarHere is a link to the webinar entitled System Demo Q3 – 2022 the first part of which concerns the eAF/DADI Human variation form
2 Sept 2022Webinar slide deck and Q&A Document2nd DADI eAF training webinar

Slide deck

Q&A Document
27 July 2022NewsletterThe 1st DADI newsletter has been published on the EMA website. The newsletter to published four times a year, will provide pharmaceutical companies and the national competent authorities (NCAs) in the EU updates on the progress of the DADI project.
26 July 2022Webinar and Q&A DocumentDADI eAF training webinar

Q&A document
21 July 2022WebinarHere is a link to the webinar entitled
1st DADI access management troubleshooting session
12 July 2022Webinar, slide deck and Q&A documentDADI Go Live Q&A Webinar
Slide deck
Q & A document
28 June 2022Webinar Quarterly System Demo (Q2-2022) – Product Life Cycle Management, R&D and Monitoring Value Streams

In the webinar, between the time points 5 minutes and approx 11 mins, there is further information on DADI and a demo of the variation web form. From 11 mins to approx 32 mins there is further information on the access management of DADI. From approx. 1 hr 20 min in to the presentation, there are responses to questions and these include responses to questions on DADI.
16 May 2022Webinar and slide deckVariations Form for Human Medicinal Products-
What will happen at Go-Live?


Slide deck
15 Mar 2022WebinarSystem Demo DADI & PMS
25 Jan 2022Webinar and slide deckDADI – Common factors in the FHIR data standard for Art. 57(2) and eAF

Slide deck
18 Jan 2022Webinar and slide deckIntroducing DADI – The Digital Application Dataset Integration Network Project to replace electronic application forms

Slide deck

Links to training videos on specific aspects of the web based variation form are available on this page.

1) Here is a link to the Product Lifecycle Management (PLM) portal.

2) Lifecycle Management Portal -Human variations eAF guide to Registration Here is a link to the updated Lifecycle Management Portal -Human variations eAF guide to Registration (Draft 1.3 16 May 2024) .
The guide aims to support the users of the eAF Portal in completing the registration steps before accessing the platform. Most of these steps are independent from the eAF Portal and correspond to those to obtain registration to use other European Medicines Agency (EMA) systems, such as Management Services for Substances, Products, Organisation and Referentials (SPOR).
For any issues or technical support with EMA’s IT systems, please raise a ticket with the EMA Service Desk portal.

3) PLM portal forum – Here is a link to the PLM portal forum.

4) PLM Portal eAF Release notes – Here is a link to an updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.0.1.12 released to production on the 27 November 2023

5) PLM Portal eAF FHIR XML Release notes– An updated version of the PLM Portal eAF FHIR XML Release notes reflecting the implementation of FHIR XML 2.0.0 in the PLM Portal eAF (to be released to production on 30 April 2024) are now available on the PLM Portal and in the section of the PLM Portal eAF, Documentation section, together with several documents to provide consumers of the FHIR XML message the easiest possible way to upgrade to the eAF XML 2.0.0 or to start the implementation now with the latest version.
The new version includes the latest official FHIR version “Release #5 (5.0.0): http://hl7.org/fhir/”. This replaces the current version FHIR Release #5: Draft Ballot (4.6.0): http://hl7.org/fhir/2021May/ which will remain online for approximately 3 months to give consuming systems time to adapt to the change.
  1. Here is a link to the document entitled Human Variations eAF-PMS Frequently Asked Questions (FAQs) Document of February 2024.
  2. Here is a link to the document entitled eAF (DADI)-PMS joint Q&A document Version 5 of February 2024.

You can view details about upcoming training sessions and Q&A clinics on this page.