29/30 November 2023
This guidance, published in March, is aimed at all persons involved in the submission of medicinal product data. It supports the development and implementation of the International Organization for Standardization (ISO) drug identification standards (IDMPs) for substances, terminologies and other information used throughout the medicinal product development life cycle worldwide. The aim of these standards is to make the international exchange of medicines information between stakeholders more accurate, complete and consistent.
The five IDMP standards and associated technical specifications were developed within the member organisations of the ISO network. Originally published by ISO in 2012, the standards provide a framework for unambiguously identifying and describing medicines with consistent documentation and terminology to enable reliable exchange of product information between regulators, manufacturers, suppliers and distributors worldwide. This framework includes data models, terms and definitions.
The guidance also explains the FDA's position and progress in harmonising the agency's standards with IDMP standards. FDA supports these standards for identifying and describing marketed non-investigational drugs with the goal of harmonising standards for the international exchange of medicinal product data. The documents should only be considered as a recommendation and not a guideline.
For more information, see the FDA Guidance "Identification of Medicinal Products - Implementation and Use".