Substances and products data management services

This content applies to human and veterinary medicines.

The European Medicines Agency (EMA) plans to deliver a Products Management Service (PMS) and a Substances Management Service (SMS) to support EU-wide regulatory activities.

The PMS and SMS will manage two of the four domains of substance, product, organisation and referential (SPOR) master data in pharmaceutical regulatory processes.

The SPOR services support the implementation of ISO IDMP standards in the European Union (EU).

The PMS and SMS will build on the data foundations of the Referentials Management Service (RMS) and Organisations Management Service (OMS), which EMA launched in June 2017.

Once the PMS and SMS are in place, pharmaceutical companies should start preparing to replace their current data-submission format, the eXtended EudraVigilance Product Report Message (XEVPRM) format, with a new ISO IDMP compatible format.

Data standard for information exchange

In January 2018, the EU Telematics Enterprise Architecture Board (EU TEAB) endorsed using the draft international data standard known as Fast Healthcare Interoperability Resources (FHIR, pronounced “fire”) as the basis for the application programming interface (API) for the PMS.

FHIR will be the data standard that supports the exchange of information about medicinal products, substances, and related referential data in the European medicines regulatory network.

EMA, the United States Food and Drug Administration (FDA) and the European medicines regulatory network are working with Health Level Seven (HL7) to incorporate the ISO IDMP standards into the FHIR specification.

    Implementation phases

    Updated: EMA is working closely with partners in the European medicines regulatory network and industry to plan the implementation of the ISO IDMP standards and terminologies in the EU.

    The implementation process is iterative. The first iteration covers a subset of the ISO IDMP standards, while later iterations will see the standards fully implemented in the EU.  

    EMA and the European medicines regulatory network are also discussing the scope of a target operating model for managing medicinal product data. The scope will determine how much development and integration with other IT systems is required to complete the target operating model. 

    The first iteration of PMS and SMS follows a phased approach.  

    Product and substance data preparatory phase

    This phase began after the launch of the RMS and OMS in 2017. During this phase: 

    • marketing authorisation holders and national competent authorities should align their systems with the released terminologies for referentials and organisations data. They should register any new terms to expand the controlled vocabularies required for the submission of substance and product data;
    • marketing authorisation holders still have to submit data on authorised medicines in the XEVPRM format to comply with their regulatory obligations under Data submission on authorised medicines (Article 57) of Regulation 726/2004;
    • EMA published version one of the EU IDMP Implementation Guide ('EU IG v1') in January 2020. It aims to provide information to stakeholders on the specification, data elements and associated business rules in preparation for implementation of ISO IDMP standards in the EU; 
    • EMA will develop and publish version two of the EU IDMP Implementation Guide ('EU IG v2'), which will describe the target operating model for the submission and maintenance of medicinal product data in the EU, and will be the basis for medicinal product data exchange in the EU.

    The European medicines regulatory network is expected to have a minimum twelve-month period to prepare for implementation once EU IG v2 is published. 

    Product and substance data transition phase

    This phase will begin no sooner than twelve months after EMA publishes EU IG v2. During this phase: 

    • marketing authorisation holders may still submit data on authorised medicines in the XEVPRM format but can also use the new FHIR format to comply with their regulatory obligations under Article 57 of Regulation 726/2004 and start enriching their data;
    • EMA will convert existing medicinal product and substance entities into the new ISO IDMP compatible format and assist industry with submitting product data in the new format;
    • marketing authorisation holders will be required to confirm this conversion was performed successfully by EMA, and to enrich the data with additional information.

    EMA is currently developing the strategy and process for enriching legacy data in collaboration with the SPOR (ISO IDMP) Task Force. EMA will publish further information before the start of the data transition phase. 

    Product and substance data submission phase

    During this phase: 

    • based on an agreed timeline, no less than twelve months after the start of the transition phase, EMA will decommission the XEVPRM format and the new FHIR format will become mandatory to comply with Article 57 data submission requirements;
    • EMA will provide a detailed plan, specifying what data to submit and when the new format will become mandatory, twelve months in advance of any change.

    Further information on PMS and SMS, including details on planning, project progress and implementation phases, is available in the minutes and presentations of the SPOR (ISO IDMP) Task Force

    EU IDMP Implementation Guide

    Update: The EU IDMP Implementation Guide for the submission of data on medicinal products defines the implementation requirements of the ISO IDMP standards and terminologies in the EU. 

    It provides information to stakeholders on the timelines, requirements, process, technical specification, data elements and associated business rules for implementation of ISO IDMP standards in EU.

    EMA published EU IDMP Implementation Guide Version 1 ('EU IG v1') in February 2020. It aims to inform stakeholders about the specification, data elements and associated business rules to help prepare for the implementation of ISO IDMP standards. It reflects current understanding based on ongoing discussions at the SPOR (ISO IDMP) Task Force

    EMA is developing version two ('EU IG v2'), which will provide the basis for medicinal product data exchange in the EU.

    The EU IDMP Implementation Guide contains the following chapters:

    • Introduction: Introduction, legal basis and scope of the EU IG for implementation of ISO IDMP
    • Chapter 1 – Pre-registration requirements: Guidance on how to get access to SPOR and what to do prior to submission
    • Chapter 2 – Initial submission: Guidance on which medicinal product information (data fields and business rules) shall be submitted
    • Chapter 3 – Maintenance (not included in EU IG v1)
    • Chapter 4 – Data quality assurance (not included in EU IG v1)
    • Chapter 5 – Data access/export (not included in EU IG v1)
    • Chapter 6 – Technical specifications on structure and format: Technical specifications for the API, contains description of principles, security, resources, calls, end-points
    • Chapter 7 – Migration guide: migration rules between xEVMPD and PMS including backwards compatibility rules.
    • Chapter 8 – Examples (not included in EU IG v1)

    EU IDMP Implementation Guide: Version 1


    About version one

    EU IG v1 is process agnostic and does not contain information on the process for submission, exchange or validation of medicinal product information. EU IG v2 will contain the operating model for PMS. 

    Although the business rules, data fields and specification presented in EU IG v1 are expected to be stable, they may be subject to modification as part of publication of EU IG v2.

    The specification of the SPOR API, as reflected in 'Chapter 6 – Technical specs on structure and Format' is subject to development and testing. As with any software it may evolve over time and will be subject to change control.

    Both this guide and the API can be expected to evolve with understanding of business processes and requirements and application of technological improvements, although no significant changes are expected.

    EU IG v1 promotes awareness and transparency of the work of the SPOR (ISO IDMP) Task Force. Stakeholders can use the available information to anticipate impacts and future workload. However, EMA encourages stakeholders to be cautious when using the information in this document to define any software development or major investment, and to ensure that modifications may be implemented in their systems in the future.

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