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).