EVS-EN ISO 27953-2:2011

This part of ISO 27593, which contains material drawn from ISO 27593-1, seeks to create a standardized framework for international regulatory reporting and information sharing by providing a common set of data elements and a messaging format for transmission of ICSRs for adverse drug reactions (ADR), adverse events (AE), infections, and incidents that can occur upon the administration of one or more human pharmaceutical products to a patient, regardless of source and destination. This International 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; conformance for this part of ISO 27953 includes parallel adoption of the ISO vocabulary work items Data Elements and Structures for the Exchange of Regulated Product Information for Drug Dictionaries (see ISO 11615, ISO 11616, ISO 11238, ISO 11239 and ISO 11240) and Structures and Controlled Vocabularies for Laboratory Test Units for the Reporting of Laboratory Results (see ISO 11595).