Drug regulators from the US, Europe, Canada, France, Netherlands, Germany and Switzerland are attempting to build a database of substances used in medicinal products to ease the exchange of such information.
The database, known as Global Ingredient Archival System (ginas), provides a common identifier for all APIs and provides a consistent definition of substances globally, consistent with the ISO 11238 standard.
The effort, which its developers describe as similar to the periodic table of elements, will help to create a system whereby complex substances that are drug ingredients are more easily identified by regulators and other stakeholders, including the US Pharmacopeial Convention and European Directorate for the Quality of Medicines & Healthcare. At the center of the project is a developing software system, called G-SRS, which aims to assist agencies in registering and documenting information about such drug substances.
“Instead of relying on drug or chemical names, which vary across countries and regions, ginas will enable substances to be defined by standardized, scientific descriptions,” NIH scientists at the National Center for Advancing Translational Sciences (NCATS) explained. “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 US Food and Drug Administration (FDA), European Medicines Agency (EMA) and others are working together with NCATS to develop the software and G-SRS is currently using 58 look-up lists to help populate the database.
FDA is currently in the process of deploying and evaluating G-SRS as a replacement for the agency’s current registration system, while the EMA is looking to incorporate more EU requirements into the database.
Working closely with the ISO standard’s authors and regulators, NCATS says the system will support all substance types described in the ICH standard and provide multiple language capabilities for the naming of substances and controlled terminology used within the system.
FDA, EMA and the World Health Organization are also planning to submit a proposal to ICH to create a group aimed at fostering the creation of more global substance identifiers.
“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,” NCATS says. “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.”
The regulators and NIH held one of their first meetings on the project last September.
NCATS Global Ingredient Archival System