EMA Lays Out First Steps in Implementing ISO Standards for Drug Identifiers

The EMA has released guidance on the first steps it will take to prepare drug sponsors to comply with new data standards for the unique identification of drugs set to take effect in 2018.

The new data standards, called SPOR for substance, product, organizations and referentials, are designed to provide a common set of definitions to be used in pharmacovigilance, submission, clinical trials and GMP inspections.

The EMA released details on two of the four SPOR data sets: organizations and referentials. The organizations data set focuses on name and address information for marketing authorization holders, sponsors, regulatory authorities and manufacturers. The referentials data set focuses on product attributes, such as dosage forms, units of measurement and routes of administration.