Description of Collaborative Activity: |
The Global Ingredient Archival System is a project that aims to provide a common identifier for all of the substances used in medicinal products, utilizing a consistent definition of substances globally, including active substances under clinical investigation, consistent with the ISO 11238 standard. The Food and Drug Administration (FDA) is utilizing software from this project to meet their obligations under the Identification of Medicinal Products (IDMP) global regulatory scheme. In 2016, the software was deployed onto FDA internal systems and FDA’s existing data was migrated into their instance (internally called Global Substance Registration Service (GSRS)). A public version of FDA’s substance definitions for use by researchers outside the agency was made available through the National Center for Advancing Translational Sciences(NCAT) website for the project. |
