scope:

1.1 ISO 27593-2: International regulatory reporting Human Pharmaceuticals This standard seeks to create a framework for international regulatory reporting and information sharing by providing a common set of data elements and messaging format for transmission of ICSRs for adverse drug reactions (ADR), adverse events (AE), infections, and incidents that may occur upon the administration of one or more human pharmaceutical products to a patient, regardless of source and destination. The standard provides a structure where reports can be exchanged in a clear and unambiguous manner such that the nature of the case, the circumstances in which it arose, and particularly the identity of the medicinal product(s) in question, can be communicated with certainty. Requirements for this use case were initially based upon ICH and conformance includes parallel adoption of ISO vocabulary work items: Data Elements and Structures for the Exchange of Regulated Product Information for Drug Dictionaries (See ISO 11615, 11616, 11238, 11239, and 11240) and Structures and Controlled Vocabularies for Laboratory Test Units for the Reporting of Laboratory Results (See ISO 11595).