Modernizing How FDA Manages Drug Substance Information
Kudos to the GSRC team at the FDA and NCATS for progress on the Global Substance Registration System. Updates were shared at a recent GSRS User Group Conference, hosted at the University of Iceland. GSRS is an open-source database application for registering and curating substances relevant to medicinal or regulated products.
These substances (now more than 200,000) include drugs, ingredients, metabolites, impurities, foods, and other materials of interest to the FDA, organized into classes including chemicals, mixtures, polymers, proteins, nucleic acids, and structurally diverse substances (e.g., organisms, extracts, etc.).
The GSRS generates unique identifiers (UNII codes) for substances that are used to tie diverse, but important data together. These data include regulatory applications, clinical trials, product information, manufacturing information, adverse events, and conditions. In the future these data will include characterization results from pharmacology and translational bioassays (see progress from the Pistoia Alliance/FDA In Vitro Pharmacology Community). The quality of curation on drug information is foundational to the accuracy and utility of predictive models developed with these data.
The newest version of the software, GSRS 3.1, features a modern, microservice based architecture that supports interoperability and FAIR principles. For more information check out the GSRS project page. For drug information that features GSRS content, access the UNII code search tool at Precision FDA or explore the NCATS Inxight Drugs portal.
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