DIN EN ISO 27953-2:2012-09

To enhance patient safety, it is noted that many countries have strong needs to exchange product safety information between varieties of stakeholders in the healthcare domain. Currently many regulatory agencies collect safety reports of adverse drug reactions, adverse events, infections, contamination and other incidents from consumers, pharmaceutical companies and healthcare professionals. Part 2 of this standard is based on the requirements given in prEN ISO 27953-1 for regulatory reporting for pharmaceutical products in human medicine. Part 2 seeks to create a framework for international regulatory reporting and information sharing by providing a common set of data elements and a messaging format for transmission of Individual Case Safety Reports (ICSRs) for adverse drug reactions (ADRs), 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. The standard supports 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 also includes parallel adoption of the ISO vocabulary work items: Data Elements and Structures for the Exchange of Regulated Product Information for Drug Dictionaries (see prEN ISO 11615, prEN ISO 11616, prEN ISO 11238, prEN ISO 11239 and prEN ISO 11240) and Structures and Controlled Vocabularies for Laboratory Test Units for the Reporting of Laboratory Results (see prEN ISO 11595). The responsible committee at DIN is Working Committee NA 063-07-03 AA "Terminologie" ("Terminology") at DIN.