Identification of Medicinal Products – Implementation and Use

30 March 2023 – the FDA published the final guidance on identifying medicinal products.

This guidance is for sponsors, applicants, and registrants who are involved in the regulatory submission of medicinal product data. The guidance supports the development and implementation of the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards for substances, terminologies, and other information for use throughout the global medicinal product development lifecycle. The purpose of these standards is to enable improved accuracy, completeness, and consistency in the international exchange of medicinal product information among stakeholders.