Drug Safety Coordinator
The EMA is currently implementing the standards developed by the International Standardisation Organisation (ISO) for the Identification of Medicinal Products (IDMP). To support the continuous improvement of pharmacovigilance oversight, the ISO IDMP standards provide data elements, formats and terminologies to unambiguously identify medicines and exchange information about them across all ICH regions. Following a phased implementation process, pharmaceutical companies will be required to submit data to EMA in accordance with the new formats and terminologies.
To facilitate the implementation of these ISO IDMP standards, the EMA is delivering a set of master data management services for the four domains of master data in pharmaceutical regulatory processes: substance, product, organisation and referential (attributes such as pharmaceutical form and route) data. These four domains or areas are known collectively as SPOR.
EMA Industry Change Liaisons have been appointed to facilitate close interaction with industry stakeholders on SPOR. The first two services, the Referentials Management Service (RMS) and Organisations Management Service (OMS) have been launched and as a next step, the EMA plans to deliver Substance Management Service (SMS) and Product Management Service (PMS) to support EU-wide regulatory activities building upon the data foundations of RMS and OMS. During 2018, this will have no impact on the submission of information on medicinal products (Article 57 Extended EudraVigilance Product Report Message, XEVPRM submissions) by MAHs or the registration of Investigational Medicinal Products (IMPs) by sponsors of clinical trials. XEVPRM submissions allow MAHs and sponsors to create proposed terms and create but also update organisations.
For the 4th quarter of 2018 the integration of RMS and OMS is planned for the Extended EudraVigilance Medicinal Product Dictionary, XEVMPD. In 2019, SPOR transition phase 1 is scheduled to start, which implies that new referentials (with the exception of substances) and new organisations will need to be pre-registered via the Agencys SPOR portal. The submission process of XEVPRMs will remain unaffected although it will no longer be possible to create proposed terms and create or update organisations via XEVPRM.
In 2020, transition phase 2 is planned will include substances, as well as referentials and organisations will need to be pre-registered via the Agencys SPOR portal. The submission of XEVPRMs will again remain unaffected. Before the IDMP standard goes into force, companies must ensure that their XEVMPD obligations are achieved.
Our cross-functional pharmacovigilance regulatory change management team is working intensely on an implementation and roll-out plan and accordingly, is on track to assure readiness in advance of the EMA mandated timelines.
For more information on this topic view EUCROF document.