‘SPOR’ – you are reminded of your Latin lessons during school years long ago and it is ‘SPQR’ that emerges before your mind’s eye? Mind the difference – the little stroke that makes the latin letter “Q”.
The Senatus Populusque Romanus (SPQR, “The Roman Senate and People”) might probably have not disputed about ‘Substance, Product, Organization and Referential (SPOR) master data’ on medicines – as has become an issue in the digital age more than 2000 years later.
To make a long story short:
SPOR is the EMA’s concept to implement the standards on data on medicines, the so-callled ISO IDMP standards (IDentification of Medicinal Products), in the European Union. IDMP standards were established by the International Organization for Standardization (ISO) to “specify the use of standardised definitions for the identification and description of medicinal products for human use”.
Theses standards were established “to facilitate the reliable exchange of medicinal product information in a robust and consistent manner, by providing a common product ’language’ ” (1).
The ISO IDMP standards comprise a framework of 5 ISO standards as are listed in Figure 1.
Figure 1: ISO IDMP – Framework of 5 ISO Standards
In order to comply with the ISO IDMP standards – as is mandated by Commission Implementing Regulation (EU) No. 520/2012 (here articles 25, 26) (2) – the European Medicines Agency (EMA) is delivering four SPOR data management services for the centralized management of master data (3):
- 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. MA, packaging and medicinal information).
- Organisations Management Services (OMS): Single source of validated organization data that be used as a reference to support EU regulatory activities and business processes. Stores master data comprising organization name and location address such as MAH, sponsors, regulatory authorities and manufacturers.
- Referentials Management Service (RMS): Stores referential master data, i.e. list of terms (controlled vocabulary) to describe the attributes of medicinal products, such as lists of dosage forms, units of measurement and routes of administration.
In this respect, EMA has established a SPOR portal (https://spor.ema.europa.eu/sporwi/), where pharmaceutical companies are invited to register and enter or update their related SPOR data. The SPOR portal provides various data management services like viewing, searching and exporting SPOR data (an important feature to import SPOR data into other documents/systems).
In summary: SPOR will – to put it in the words of Nicols (4) – be the «home of an EU-wider source of validated data that can be re-used by EMA, NCAs and industry in support of regulatory activities (e.g. Pharmacovigilance, marketing applications or clinical trials) across the product lifecycle, for products that are regulated in the EU.»
At this point you may groan while thinking about another platform to register on, another database to fill with data additional work – while hoping for relief from “drowning in data”.
A ray of hope – with an example from EU-eCTD publishing: When filling out one of the (fillable) EU electronic application form (e.g. electronic Application Form (eAF) or electronic Variation Application Form (VAF)) , RMS and OMS data can be directly imported from the SPOR portal into the fillable forms (see Figure 2 as an example) – provided the applicant had previously registered on the SPOR portal and entered the related data.
The import of standardized data into an eAF – a process that is faster, less prone to errors, less content validation issues. A small step in daily business – but a major step towards digital transformation. It’s probably more than the little stroke that makes the difference.
- (1) Introduction to ISO Identification of Medicinal Products, SPOR Programme. EMA/732656/2015. European Medicines Agency. Information Management Division. 29 November 2016. https://www.ema.europa.eu/en/documents/other/introduction-iso-identification-medicinalproducts- spor-programme_en.pdf (accessed 11 July, 2019).
- (2) Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council. https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1562850778829&uri=CELEX:32012R0520 (accessed 11 July 2019).
- (3) Offical website of the European Medicines Agency. Human regulatory / Research and development / SPOR master data. https://www.ema.europa.eu/en/human-regulatory/research-development/data-medicines-iso-idmp-standards/substance-product-organisation-referential-spor-master-data (accessed 11 July 2019).
- (4) Nichols, J. eCTD, xEVMPD, SPOR and IMPD update: Prepare yourself for 2019. (Webinar recording). Posted on 13.12.2018. https://www.youtube.com/watch?v=HSqoYV9Emas; accessed May 13, 2019.