Issue Date: March 30, 2023
Issued by: Center for Drug Evaluation and Research
Topic(s): Electronic Submissions,
Status: Final
Identification of Medicinal Products — Implementation and Use
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.
Download the Guidance Document
