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USFDA Guidance: Identification of Medicinal Products — Implementation and Use

Today (31 March 2023) USFDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research released updated guidance on "Identification of Medicinal Products — Implementation and Use".

IDMP stands for Identification of Medicinal Products, which is a global standard for identifying and exchanging information about medicinal products. In order to improve the safety, efficacy, and availability of medicines in the United States, the FDA (United States Food and Drug Administration) recognizes the importance of IDMP and is working toward its implementation.

The guidance is aimed at sponsors, applicants, and registrants involved with the regulatory submission of medicinal product data and supports ISO Identification of Medicinal Products (IDMP) standards for substance, terminologies, and other information for use throughout the entire lifecycle of medicinal product development.

In this guidance, FDA explains its position and progress on aligning its standards with IDMP standards, which the Agency supports, so that marketed medicines, with the exception of investigational medications, can be identified and described with the goal of harmonizing international standards for the exchange of medicinal product data.

For the purpose of reducing the risk of errors in data entry and interpretation, interoperability of healthcare information systems and standards is crucial, as is the ability to identify global medicinal product safety issues, including counterfeit products, using advanced analytics.

The FDA collaborates with a wide range of stakeholders to resolve issues hindering IDMP implementation beyond local or regional boundaries, including international standards development organizations (i.e., ISO, HL7 (Health Level 7 International)), regulatory agencies, and nongovernmental organizations.

Click this LINK to understand more about the USFDA's standpoint & envision for the Identification of Medicinal Products.


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