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.
FDA is collaborating with 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. FDA and the European Medicines Agency are exploring the feasibility of Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) message for exchanging substance information.