Implementation of the ISO IDMP standards
| | Implementation of the ISO IDMP standards
The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP). These are a set of common global standards for data elements, formats and terminologies for the unique identification of and the exchange of information on medicines. Following a phased implementation process, pharmaceutical companies will be required to submit data on medicines to EMA in accordance with these formats and terminologies. The five ISO IDMP standards should simplify the exchange of information between all stakeholders, enhancing interoperability of systems at European Union (EU) level and internationally. They define data elements and structures for unique identification and exchange of regulated information on: - substances (ISO 11238);
- pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO 11239);
- units of measurement (ISO 11240);
- regulated pharmaceutical product information (ISO 11616);
- regulated medicinal product information (ISO 11615).
EMA's approach to implementing the ISO IDMP standards is based on the four domains of master data in pharmaceutical regulatory processes: substance, product, organization and referential (SPOR) data. More about implementation of the ISO IDMP please find on the website of the European Medicines Agency. 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: |
