The EU Digital Application Dataset Integration (DADI) project on web-based regulatory application forms is currently in progress.
This project should have a wide ranging and positive impact on industry stakeholders and regulatory agencies in the EU. At its core appears to be a drive to increase efficiencies at many levels by replacing the currently used electronic Application Forms (eAFs) 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.
Before launching into the DADI project, it is important to have a basic understanding of the following terms.
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
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.
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.
- 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
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
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.
The delivery timeline is as follows:
|Month/year||Release of initial Fast Healthcare Interoperability Resources (FHIR) message specification for the form||Form release date|
|September 2021||human medicinal product variation applications form|
|February 2022||human medicinal products initial marketing authorisation applications|
|Late April 2022||human medicinal product variation applications form.|
|September 2022||human medicinal product initial marketing authorisation applications form|
|April 2023||human medicinal products renewal application form. |
- 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 EU commission website here. Of the information provided, this document entitled DADI eAF Project Q&A Digital Application Dataset Integration (DADI) Project Question and Answers is quite helpful in helping to understand more about the project. This document will be updated on an ongoing basis.