Improving Regulated Product Safety and Availability
Globalization has fueled an ever-rising number of imported FDA-regulated products and ingredients. It has also spurred the growing movement of clinical trials abroad. As our world becomes more interdependent, FDA has been working closely with the National Institutes of Health (NIH) and international stakeholders to promote the knowledge-sharing required to tackle globalization’s impacts on our nation’s public health.
Among these impacts has been an unmet need for a system that can accurately track the global supply chain of ingredients in FDA-regulated products. Currently, consumers, clinicians, and researchers do not always have a way to tell what ingredients are contained in commercial products that are domestically and foreign-sourced. This is due to the fact that certain ingredients are not included in the labeling and others are labeled ambiguously. For example, food product labels often contain very general terms like “spices” or “artificial flavoring.” There is clearly a need for an accurate substance repository. This common system with common content will enable global monitoring of food, medicinal, tobacco, and cosmetic products and help the global community achieve this goal.
To this end, FDA’s Health Informatics team, NIH's National Center for Advancing Translational Sciences (NCATS), and the European Medicines Agency (EMA) have collaborated to create a Global Substance Registration System (GSRS) that will enable the efficient and accurate exchange of information on what substances are in regulated products.
Instead of relying on names--which vary across regulatory domains, countries, and regions—the GSRS knowledge base makes it possible for substances to be defined by standardized, scientific descriptions. It classifies substances as chemical, protein, nucleic acid, polymer, structurally diverse, or mixture as detailed in the ISO 11238 (International Organization for Standardization) and ISO DTS 19844.
FDA’s GSRS generates Unique Ingredient Identifiers (UNIIs) used in electronic listing as seen in DailyMed. It is also used for other regulatory activities throughout product life cycles. This would encompass clinical trial phases, product marketing and postmarket surveillance.
Beginning in 2006, FDA created a Substance Registration System and unique ingredient identifiers because no other code system met the agency’s regulatory needs. UNIIs can be generated at any time in the regulatory life cycle for any substance, from an atom to an organism.
Public UNII sources include: A flat file (spreadsheet) and simple search developed for electronic listing submitters hosted at precisionFDA and a public Global Substance Registration System hosted by the National Center for Advancing Translational Sciences. Users of precisionFDA can filter and export GSRS public data and create GSRS JSON records in their own user space. They can also use a precisionFDA shared space to collaborate with the FDA-SRS team.
For UNII requests, data issues, or questions about GSRS contact:
Quick Guide for Creating a Structure Data (SD) File
The Quick Guide to Creating a Structure-Data File (SD File) for Electronic Common Technical Document (eCTD) Submissions assists industry in how to prepare SD Files for ANDAs, NDAs, and BLAs and provides additional resources.