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# Guide on Harmonized Medicinal Product Identification
- URL: https://www.fdaweb.com/guide-on-harmonized-medicinal-product-identification/
- Published: 2023-03-31T12:00:00.000Z
- Updated: 2026-09-14T18:23:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154110

FDA has released a [final guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/identification-medicinal-products-implementation-and-use?ref=fdaweb.com) entitled “Identification of Medicinal Products — Implementation and Use” that is intended to support 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,” the document says. “The five IDMP standards, along with their corresponding technical specifications, were developed within the ISO network member organizations.”

The agency says that the standards, which were published by ISO in 2012, “provide a framework to uniquely identify and describe medicinal products with consistent documentation and terminologies to provide for the reliable exchange of product information between global regulators, manufacturers, suppliers, and distributors.” It includes data models, terms, definitions, and some controlled vocabulary code lists. The guidance also explains FDA’s position and progress on harmonizing its standards to IDMP standards to identify and describe marketed medicinal products particularly in the international product data exchange arena.