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August 18, 2023

IDMP - New FDA Guidance for Medicinal Products

Advisory Team

In March 2023, the FDA released a new guidance for the "Identification of Medicinal Products — Implementation and Use" in the Life Sciences Industry.

As a result of their analysis, FDA determined the conformance of FDA standards of Unique Ingredient Identifier (UNII); Structured Product Labeling (SPL) Pharmaceutical Dosage Form Terminology; Unified Code for Units of Measure (UCUM), and National Drug Code (NDC) to the ISO IDMP standards ISO 11238, ISO 11239, ISO 11240, and ISO 11615, respectively.

FDA has also determined that for global implementation of ISO 11616 (PhPIDs), global identifiers for substances and dosage forms will need to be defined. They envision that global implementation of the IDMP standards should be conducted using a phased approach.

Red Nucleus' global teams can help your organization understand what these guidances mean for you. Contact us to learn more.

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