The PMS and SMS will manage two of the four domains of substance, product, organisation and referentials (SPOR) master data in pharmaceutical regulatory processes. SPOR data management services will facilitate the reliable exchange of medicinal product information in a robust and consistent manner.
The SPOR services support the implementation of ISO IDMP standards in the EU / EEA.
The PMS and SMS build on the data foundations of theReferentials Management Service (RMS) andOrganisations Management Service (OMS), which EMA launched in June 2017.
The PMS and SMS implementation process is iterative, in steps. The first iteration covers a subset of ISO IDMP data fields. Later iterations will see the standards fully implemented in the EU.
The first iteration of the SMS, in 2019, enabled users to request the registration of a new substance term or the update of an existing substance term through EMA Service Desk. This allows EMA to manage the substance data. Future iterations of SMS will include synchronising SMS with the European substance reference system (EU-SRS) database and delivering an SMS user interface.
The first iteration of the PMS will cover a subset of the authorised medicinal product part of the ISO IDMP standards. As part of this iteration, the new ISO IDMP compatible data submission format (HL7 FHIR) replaces the current data submission format, the eXtended EudraVigilance Product Report Message (XEVPRM).
Future PMS iterations will implement other product data elements of the authorised medicinal product and the investigational medicinal product part of the ISO IDMP standards.