SPOR (ISO IDMP) Task Force

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.

EMA has established a SPOR (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.

EMA publishes the agendas and minutes of the SPOR (ISO IDMP) Task Force meetings. 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.

How useful was this page?

Add your rating
Average
1 rating