Substance, product, organisation and referential (SPOR) master data

The European Medicines Agency (EMA) is delivering four data management services for centralised management of master data: substance, product, organisation and referential (SPOR). They comply with standards set by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP). These standards make it easier to exchange of medicine information in a reliable manner.

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

For more information, see:

• ISO: Global standards for trusted goods and services

Also on this topic

• SPOR user registration
• Organisation Management Service (OMS)
• Referentials Management Service (RMS)
• Substance and product data management services
• SPOR (ISO IDMP) Task Force

Four domains of master data

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 human medicinal product based on regulated information (e.g. marketing authorisation, packaging and medicinal information)
• Organisations 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

While the ISO IDMP standards relate to human medicinal products, SPOR applies to both human and veterinary domains. Human and veterinary medicines will use the same SMS, OMS and RMS services in terms of data, format and processes for submitting and maintaining master data.

For a more detailed introduction to the SPOR programme and the ISO IDMP standards, see:

Introduction to ISO Identification of Medicinal Products, SPOR programme

Reference Number: EMA/732656/2015 Summary:

Introduction to ISO Identification of Medicinal Products, SPOR programme

For more information on SPOR services, please see:

• Substance and product data management services
• Organisations Management Service (OMS)
• Referentials Management Service (RMS)

Benefits of SPOR services

Implementing the SPOR data management services offers a number of key benefits for the regulation of medicines:

• 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 re-used across different procedures and regulators.

These operational benefits should have a positive impact on public health and safety.

The full benefits will become visible incrementally as EMA implements the SPOR programme phases and exploits opportunities for integrating the SPOR services with other systems used for regulatory procedures, together with EMA's regulatory partners.

Implementing the SPOR programme

The European Commission, European Union (EU) Network Data Board and EU ISO IDMP Task Force have endorsed a phased implementation of the ISO IDMP standards. 

This will allow: 

• lessons learned during each phase to be applied to subsequent phases, processes and systems to mature over time;
• stakeholders to gain an understanding prior to the full roll out.

First phase

The first phase of SPOR implementation focuses on delivering the RMS and OMS, which lay the data foundations for the subsequent delivery of PMS and SMS.

The RMS and OMS already supply master data to the electronic application forms (eAF) for submitting applications to EMA and national competent authorities for initial marketing authorisations, variations and renewals for human and veterinary medicines. 

Users can select information supplied directly by these master data services when preparing their regulatory submission.

OMS and RMS enable organisation and referential data to be entered once, and reused many times in other business processes and related regulatory procedures

Second phase

The second phase of SPOR implementation focuses on delivering the PMS and SMS, as well as extending the RMS and OMS.

EMA is consulting stakeholders on the benefits of using the SPOR services to support regulatory submissions using the Common European Single Submission Portal (CESSP).

The implementation of SPOR required a coordinated Task Force between 2015 and 2022. This brought together EMA and national competent authorities, industry representatives and software vendors.

The Task Force was no longer required following the transition to Agile way of working of SPOR governance.

Events

The regulatory data management service hosts two types of webinars: services webinars and status update webinars.

The webinars provide practical information for users on regulatory data management and the functioning of SPOR and XEVMPD. 

The yearly SPOR services webinar consists of series of sessions organised over two weeks. Each session focuses on a specific SPOR service, covering:

• general principles and rules;
• key processes;
• key performance and data quality metrics;
• updates and next steps.

The quarterly SPOR status update webinar consists of a single session and focuses on:

• achievements from the past quarter;
• plans for the upcoming quarter;
• key highlights for SPOR users.

To find upcoming or past SPOR events, visit the EMA 'Events' page and filter via the keyword 'SPOR':

• Events

Guidance

Guidance is available for stakeholders supporting the implementation of the SPOR master data programme. 

This document supports stakeholders using the SMS, PMS, OMS and RMS services.

In addition, EMA will make a 'frequently asked questions' document available in October 2024.

Submission and maintenance of data on authorised human medicines is mandatory. It is currently based on a format called Extended EudraVigilance Product Report Message (XEVPRM). This will be replaced by the ISO IDMP compatible format in due course.

On-boarding of users to Substance, Product, Organisation and Referentials (SPOR) data services

Reference Number: EMA/307181/2017 version 5

For more information, see:

• Data submission on authorised medicines (Article 57)
• How to submit information on authorised and investigational medicines