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  1. FDA Data Standards Advisory Board

Substance Identification

ISO 11238 Substance Identification (SubID) provides an information model to define and identify substances within medicinal products or substances used for medicinal purposes. The standard identifies five types of substances: chemicals; proteins; nucleic acids, polymers and structurally diverse material, such as viruses, cells, and tissues (as well as, mixtures).

Registration of substances enhances the regulatory review of active and inactive substances in submissions, facilitates understanding of the relationships to other substances, and understanding of relationships to products from a quality, safety and drug utilization perspective.

Currently, there is no global substance identifier to use for the implementation of global IDMP, specifically as input to the generation of a global PhPID.   FDA continues to work with other regulatory agencies and with the Global IDMP Working Group to evaluate global substance identifiers.

FDA continues work with the National Center for Advancing Translational Sciences (NCATS) to develop an ISO 11238-compatible Global Substance Registration System (G-SRS) and implement G-SRS within FDA’s information technology environment.  G-SRS allows authorized agents to register new substances, and curate, review, and exchange existing substance data in the repository.  Further, FDA continues to collaborate with the European Medicines Agency (EMA) for their compatible instance of G-SRS, named the EU SRS.  Together EMA and FDA are working with HL7 (HL7) on a Fast Healthcare Interoperability Resources (FHIR) message for exchanging substance information.

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