This article briefly introduces the Substances, Products, Organisations and Referentials (SPOR) data management services for governance of master data, explaining why SPOR has been implemented and what it is. SPOR will make it easier for both regulators and Industry to exchange information on medicines in a reliable manner.
Identification of Medicinal Products (IDMP)
Drug safety and good pharmacovigilance across the globe relies on the correct identification and description of medicinal products for adverse event reporting, thereby driving a need for international standardised terminology. In order to achieve this the International Organization for Standardization (ISO) has developed five standards for the Identification of Medicinal Products (IDMP), namely the ‘Data elements and structures for unique identification and exchange’ of:
- Regulated medicinal product information (ISO 11615:2017)
- Regulated pharmaceutical product information (ISO 11616:2017)
- Regulated information on substances (ISO 11238:2018)
- Regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO 11239:2023)
- Units of measurement (ISO 11240:2012)
Within Europe, the IDMP standards were integrated into EU law through Articles 25 and 26 of the Commission Implementing Regulation (EU) No 520/2012.
Substances, Products, Organisations and Referentials (SPOR)
In order to implement the IDMP standards in the EU, the EMA have developed a repository of standardised data that can be used by both Industry and regulators across Europe to provide information for regulatory procedures. This repository for data management services for master data on Substances, Products, Organisations and Referentials is known as ‘SPOR’, as follows:
- S or SMS – substances management services – NOT ACTIVATED. The active substance has historically been registered within the list of European Union Telematics Controlled Terms (EUTCT), but in 2019 users were able to request the registration of a new substance term or the update of an existing substance term through the EMA Service Desk. When the SMS is activated it will be accessible through the SPOR portal.
- P or PMS – products management services – NOT ACTIVATED. The PMS concerns marketed products and sits within the ‘Product Lifecyle Management (PLM)’ portal and not the SPOR portal. It can be accessed in a read only format using the SPOR tools Application Programming Interface (API) and Product User Interface (PUI). Please note, for regulatory procedures initiated during development, excluding clinical trials, the research product unique to a particular company needs to be registered and given a ‘Research Product Identifier’ or ‘RPI’ which is completed through the EMA IRIS submission portal using data from OMS and RMS.
- O or OMS – organisations management services – ACTIVE. The sponsor (and any company making submissions on the sponsors behalf) needs to be registered and given an organisation number ORG-xxxxxxxxxx and each site given a location number LOC-xxxxxxxxxx. Registration of an individual person is also possible.
- R or RMS – referential management services – ACTIVE. This contains all standard terms used within regulatory procedures and in June 2017 replaced EUTCT as the central repository and provider of referentials data. If a non-standard term is applicable for a specific product, it would have to be included here before regulatory submissions can be made. The referential lists of standard terms are owned by EMA (e.g., age ranges, adverse event report type, terms used for the eligibility of the centralised procedure, and many more) as well as other organisations such as MedDRA MSSO (e.g., Medical Dictionary For Regulatory Activities), World Health Organisation (WHO) (e.g., ATC classification) and European Directorate for the Quality of Medicines (EDQM) (e.g., administration method, dosage form, package, units of presentation, and many more).
The OMS and RMS are operational within the SPOR portal and data is currently being used to inform many regulatory procedures managed through the EMA IRIS portal (such as scientific advice, Paediatric Investigation Plan, orphan designation) as well as the electronic application form (eAF) (web-based forms that developed by the Digital Application Dataset Integration (DADI) project) which replaces the pdf forms used for initial Marketing Authorisations, variations and renewals.
Article 57 information (xEVMPD) and the PMS
Before the incorporation of the ISO IDMPs into EU law in 2012, the 2010 pharmacovigilance legislation provided for the submission of data on medicines by the Marketing Authorisation Holder (MAH) in order to achieve a complete inventory of all medicines authorised centrally via the EMA and those authorised at national level. Article 57(2) of Regulation (EC) No 726/2004 provided for a database where the MAH and sponsors of clinical trials submit data that are published in the eXtended EudraVigilance Medicinal Product Dictionary (xEVMPD) using the EMA’s data-entry tool called EVWEB in XEVPRM format. The xEVMPD includes information on the name of the medicinal product, the MAH, MA status, pharmacodynamic properties, therapeutic indications coded in MedDRA, qualitative and quantitative composition of the medicinal product, including the list of active substances (and strength), adjuvants (and strength) and excipients, medical device description for combined advanced therapy medicinal products, pharmaceutical form, posology and method of administration, pharmacovigilance particulars and an electronic copy of the latest approved Summary of Product Characteristics.
Additionally, Sponsors of clinical trials are required to submit their investigational medicinal product information in the xEVMPD as per Article 81(3) of the Clinical Trial Regulation (EU) No 536/2014. Data on investigational medicinal products within the xEVMPD is currently used to inform the Clinical Trials Information System (CTIS), the online portal submission and supervision of EU clinical trials. The ‘EU product number’ and ‘EU substance number’ for the development medicinal product assigned within the xEVMPD is included within the CTIS submission.
The data within the xEVMPD (Article 57) database (and the EMA pharmacovigilance database SIAMED) have been migrated to the PMS with the aim for the PMS to eventually replace the xEVMPD (Article 57) database, although the exact timelines for this have not been confirmed by the EMA and this is unlikely before 2026.
The PMS is available for registered users within the Product Lifecycle Management portal (PLM portal) and can be accessed by Industry through the PMS Application Programming Interface (API) in read-only mode (from July 2024) as well as the Product User Interface (PUI) in read-only mode for CAPs (May 2024) and non-CAPs (September 2024). From January 2025 Industry have been able to use the edit functionalities of the PUI, although this has been initially limited to PMS manufacturing information and pack sizes for the purposes of managing drug shortages.
As for the OMS and RMS, the data within the PMS will directly inform the EMA submission portal IRIS as well as the electronic application forms (eAFs). The PMS will be implemented in the new ISO IDMP compatible format using ‘HL7 FHIR’ as the application programming interface, which allows the web-based eAFs to read data from the PMS and display it in the web forms.
Conclusions
The evolution of data management services for medicinal products from a tool for international good pharmacovigilance to a repository system for master data on medicinal products is ongoing. The result will be a data management service that allows the EMA to provide high quality information on medicinal products, which can be used by both Industry and all EU regulators during many different EU regulatory processes.
Questions?
We hope you found this article useful. If you have any questions on this topic or need assistance with regulatory data management to support your own programme, please don’t hesitate to get in touch. You can contact us through our website, via email (info@s-cubed.co.uk), or by telephone (S-cubed Ltd: +44 1235 77 22 60).