Description of Collaborative Activity: |
The Global Substance Registration System, formerly known as the Global Ingredient Archival System (Ginas) is a project that aims to provide a common identifier for all substances used in medicinal products, utilizing a consistent definition of substances globally, including active and inactive substances under clinical investigation, consistent with the ISO 11238 standard. The FDA and other stakeholders around the world including the European Union are 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. A public version of FDA's substance definitions for use by researchers outside the agency was made available through NCATS' website for the project. The FDA uses GSRS to publish updates to their substance catalogs on a monthly basis which are also available for public use on the NCATS project site. |
