Description of Collaborative Activity: |
GSRS is a public software and web application that supports the registration and documentation of substances found in medicinal products. Importantly, the definition of substances is based on a global and consistent definition (ISO 11238 standard). The software has been heavily utilized at the FDA since 2016, and has also been adopted by other regulatory agencies around the world, such as EMA (European Medicines Agency), BfArM (Federal Institute for Drugs and Medical Devices) and WHO-UMC. NCATS provides access to a public instance of the software, and to the latest publicly available data on substance definitions and properties, as provided by the FDA, for use by the broader translational research community. |
