The GSRS resource is a registration system for the ingredients in medicinal products. This project, developed by NCATS scientists, makes it easier for regulators and other stakeholders to exchange information about substances in medicines, supporting scientific research on the use and safety of these products.
The GSRS effort is similar to the periodic table of elements, which is a basic system of classifying chemical elements based on specific scientific criteria. These classifications are accepted worldwide, but that was not always the case. Scientists and alchemists of the past used to describe simple substances using arbitrary names, symbols and categorization. It was difficult for early scientists to agree about what was a real element and even more difficult to be sure, systematically, that the scientists were describing the same substance with their specific names and symbols.
The development of the periodic table of elements revolutionized the way scientists talked about substances, enabling the use of a common terminology for known and unknown elements. However, no such system currently exists for identifying the complex substances that are ingredients in today’s medicinal products. The main goal of GSRS is the production of software, called GSRS, to assist agencies in registering and documenting information about substances found in medicines.
Instead of relying on drug or chemical names, which vary across countries and regions, GSRS will enable substances to be defined by standardized, scientific descriptions. First, the substance is classified into one of a few categories (e.g., chemical, protein, plant substance). Then researchers use certain criteria (e.g., chemical structure, DNA sequence) to distinguish substances in each category from one another. When enough information is available, a substance is assigned a unique identification code, which can be used as a quick way to refer to that substance in the future.
Staff from the U.S. Food and Drug Administration (FDA) and regulatory authorities from several other countries work together with NCATS on GSRS software development. FDA deployed GSRS software in 2017 as a replacement for the agency’s previous registration system. In addition, the European Medical Agency has committed to using the GSRS software.
The GSRS effort provides a common identifier for ingredients in medicinal products by using a consistent definition of substances, including active substances under clinical investigation, based on the ISO 11238 standard.
Working closely with that standard’s authors and regulatory authorities from various countries, NCATS is developing an information system to register and store substance-related information and provide identifiers. This effort will ensure that a robust substance registration software (GSRS) supports the additional needs of national and regional authorities and is consistent with the ISO 11238 standard. The system will support all substance types described in the standard and provide multiple language capability for the naming of substances and controlled terminology used within the system.
Public Health Impact
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 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 for pharmaceutical ingredients.