Substance, product, organisation and referential (SPOR) master data
This content applies to human and veterinary medicines.
The European Medicines Agency (EMA) is implementing the ISO IDMP standards for the identification of medicinal products in a phased programme, based on the four domains of master data in pharmaceutical regulatory processes: substance, product, organisation and referential (SPOR) data.
EMA is delivering four SPOR data management services for the centralised management of master data that comply with the ISO IDMP standards.
The aim is to facilitate the reliable exchange of medicinal product information in a robust and consistent manner.
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 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.
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 .
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 learnt during each phase to be applied to subsequent phases, processes and systems to mature over time and stakeholders to gain an understanding prior to the full roll out.
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
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 requires a coordinated programme involving all key stakeholders, including EMA, national competent authorities, industry representatives and software vendors.
The submission and maintenance of data on authorised human medicines is already mandatory since July 2012. This is based on a format called Extended EudraVigilance Product Report Message (xEVPRM), which will be replaced by the ISO IDMP compatible format.
EMA has a master data management roadmap, which aligns with the approach to implementing the ISO IDMP standards. It is currently being updated.