Data on medicines (ISO IDMP standards): research and development

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).

EMA is implementing the standards in a phased programme based on the four domains of master data in pharmaceutical regulatory processes: substance, product, organisation and referential (SPOR) master data.

In this section

• Substance, product, organisation and referential (SPOR) master data

In other sections

• Data submission on investigational medicines: guidance for clinical trial sponsors