EMA Establishes Standards for Producing Unique Identifiers for Drugs
Drugmakers selling into the EU will have two years to begin complying with a new set of ISO global standards that will create a unique identifier for drugs.
The five ISO IDMP standards define the data elements and structures for the unique identification of 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 pharma product information (ISO 11616); and
- Regulated medicinal product information (ISO 11615).