Global Substance Registration System

National Center For Advancing Translational Sciences

Investigators

Linked publications, trials & patents

Abstract

Globalization presents tremendous challenges and opportunities for national regulatory agencies, the pharmaceutical industry and global health. Emerging diseases and the health effects of catastrophic events respect no national boundaries, nor does the increasing volume of substandard, contaminated and count for pharmaceutical ingredients, counterfeit products that overburdens national regulators. Ingredients for pharmaceutical products are typically sourced on a global basis, and it is rare that all ingredients for a single product are produced within one jurisdiction. To regulate the global supply chain efficiently and better respond to and prepare for catastrophic events, it is essential to have a global information system. GSRS (Global Substance Registration System) is a registration system for the ingredients in medicinal products. This project, developed by NCATS scientists, makes it easier for regulators at FDA and other stakeholders to exchange information about substances in medicines, supporting regulatory oversight and scientific research on the use and safety of medicines. GSRS introduced a new Wiki which provides comprehensive information for both use, installation, and customization of the application. GSRS continues to introduce additional modules for tracking products and impurities related to substances as well as handling large structures and extending the definition of structurally diverse substances. NCATS was an integral stakeholder in the formation of the GSRS Consortium, led by the Pistoia Alliance in conjunction with GSK and USP.