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.
The aim is to facilitate the reliable exchange of medicinal product information in a robust and consistent manner.
EMA is delivering a set of SPOR data management services for the centralised management of master data that comply with the ISO IDMP standards.
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);
- 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.