Substance and product data management services
This content applies to human and veterinary medicines.
The European Medicines Agency (EMA) plans to deliver a Substance Management Service (SMS) and Product Management Service (PMS) to support EU-wide regulatory activities.
The PMS and SMS will manage two of the four domains of substance, product, organisation and referential (SPOR) master data in pharmaceutical regulatory processes.
The SPOR services support the implementation of ISO IDMP standards in the European Union (EU).
The PMS and SMS will build upon the data foundations of the Referentials Management Service (RMS) and Organisations Management Service (OMS), which EMA launched in June 2017.
Once the PMS and SMS are in place, pharmaceutical companies should start preparing to replace their current data-submission format, the eXtended EudraVigilance Product Report Message (XEVPRM) format, with a new ISO IDMP compatible format.
Data standard for information exchange
In January 2018, the EU Telematics Enterprise Architecture Board (EU TEAB) endorsed using the draft international data standard known as Fast Healthcare Interoperability Resources (FHIR, pronounced “fire”) as the basis for the application programming interface (API) for the PMS.
This means that in future FHIR will be the data standard that supports the exchange of information about medicinal products, substances, and related reference data in the European medicines regulatory network.
EMA, the United States Food and Drug Administration (FDA) and the European medicines regulatory network will work together with Health Level Seven (HL7) to incorporate the ISO IDMP standards into the FHIR specification.
This allows SPOR to become compatible with HL7 standards while retaining flexibility in defining a new data model for ISO IDMP-based data. It ensures that the European medicines regulatory network aligns with international standards, a key objective of the EU Telematics strategy.
It enables EMA to progress in designing technical solutions and messaging formats for the SPOR programme, to realise technical efficiencies while respecting the content and processing requirements of the ISO IDMP standards.
EMA is working closely with partners in the European medicines regulatory network and industry to develop guidance to define the implementation requirements of the ISO IDMP standards and terminologies in the EU. This is known as the EU IDMP implementation guide for the submission of data on substances and products.
Following the launch of the RMS and OMS services in June 2017, a transition phase began in the implementation of SPOR. It contains two sub-phases:
- Product and substance data pre-submission:
- marketing authorisation holders and national competent authorities should align their systems with the released terminologies for referential and organisation data and register any new terms to expand the controlled vocabularies required for the submission of substance and product data;
- marketing-authorisation holders will still have to submit data on authorised medicines in the XEVPRM format during this phase to comply with their regulatory obligations under Article 57 of Regulation 726/2004;
- ISO documents and EU implementation guides are due to be finalised and published.
- Product and substance data submission:
- EMA will convert existing medicinal product and substance entities into the new ISO IDMP compatible format and assist industry in the submission of products via the new format;
- pharmaceutical companies will be required to confirm this conversion performed by EMA, and to enrich the data with additional information;
- EMA will then decommission the XEVPRM format and the new format will become mandatory to comply with Article 57 data submission requirements. The Agency will provide a detailed plan including what data is to be submitted and communicate when the new format is to become mandatory twelve months in advance of any change.
Subsequent iterations of products will be implemented as required to fully complete the implementation of the ISO IDMP standards.
Once EMA has published the EU implementation guide, there will be at least twelve months until EMA launches a first iteration of these data management services and a further twelve months until they become mandatory.
Further information on SMS and PMS, including details on 2018 planning and beyond, are available in the presentation below:
In July 2018, EMA published an update on the progress made and next steps in the implementation of the SMS and the PMS. This update consists of information presented at a workshp and SPOR Task Force meeting in June 2018: