The submission and maintenance of data on authorised human medicines is already mandatory since July 2012.
The implementation of SPOR requires a coordinated programme involving all key stakeholders, including EMA, national competent authorities, industry representatives and software vendors. OMS and RMS enable organisation and referential data to be entered once, and reused many times in other business processes and related regulatory proceduresĮMA is consulting stakeholders on the benefits of using the SPOR services to support regulatory submissions using the Common European Single Submission Portal (CESSP). Users can select information supplied directly by these master data services when preparing their regulatory submission. 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.
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.
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 European Commission, European Union (EU) Network Data Board and EU ISO IDMP Task Force have endorsed a phased implementation of the ISO IDMP standards. 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. These operational benefits should have a positive impact on public health and safety.
Referentials Management Service (RMS)- lists of terms (controlled vocabularies) to describe attributes of products, e.g.Organisation Management Service (OMS)- data comprising organisation name and location address, for organisations such as marketing authorisation holders, sponsors, regulatory authorities and manufacturers.
marketing authorisation, packaging and medicinal information) Product Management Service (PMS) - harmonised data and definitions to uniquely identify a medicinal product based on regulated information (e.g.Substance Management Service (SMS) - harmonised data and definitions to uniquely identify the ingredients and materials that constitute a medicinal product.The four SPOR services cover the four domains of SPOR master data: The aim is to facilitate the reliable exchange of medicinal product information in a robust and consistent manner. 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.ĮMA is delivering four SPOR data management services for the centralised management of master data that comply with the ISO IDMP standards. This content applies to human and veterinary medicines.