SPOR programme: stakeholder engagement

This content applies to human and veterinary medicines.

The European Medicines Agency (EMA) and European medicines regulatory network are pursuing an open dialogue with industry and all stakeholders to discuss aspects of implementing the ISO IDMP standards in the EU through the substance, product, organisation and referential (SPOR) programme.

Stakeholders include national competent authorities, software vendors, the United States Food and Drug Administration, the European Directorate for the Quality of Medicines and HealthCare, the European Commission and will soon extend to the Swiss Agency for Therapeutic Products and veterinary stakeholders.

A webinar on 4 August 2016 supported industry in understanding the SPOR data services, including benefits and high level changes, implementation timelines and engagement approach:

EMA has established an ISO IDMP Task Force with the involvement of terminology organisations, software vendors and developers of medicinal product dictionaries or databases.

The task force is responsible for advising on the planning, development, implementation and maintenance of the ISO IDMP standards in the EU, in line with requirements defined at international level and based on agreed EU implementation principles.

For more information on meetings of the ISO IDMP Task Force:

EMA publishes the agendas and minutes of the task force meetings on the meeting pages. The minutes are made available following their adoption at the subsequent task force meeting.

The PDF iconterms of reference for the task force is also available, as adopted by the Data Integration Steering Committee.

In June 2015, EMA held a dedicated ISO IDMP Information Day on the activities, discussions and outcomes of the ISO IDMP Task Force, as part of the Agency's activities to communicate efficiently and transparently to all interested stakeholders.

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