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 release 3.0.3 updated export pipelines, improved registration searching and name formatting as well as allowed for the application to have a customizable homepage for instances hosted by other institutes and companies. GSRS release 3.1 will include the ability to stage and review records during bulk import to improve the process for data sharing and collaboration between GSRS instances of global regulators as well as the submission of new drug applications from pharmaceutical companies.