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

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.