When people want to understand a word, they turn to a dictionary for its widely accepted definition, history, and relation to other words. In the scientific field, the need to access standardized definitions is no different, and that’s exactly why the Global Substance Registration System (GSRS) was developed.
Initiated in 2013 by the US Food and Drug Administration (FDA), United States Pharmacopeia (USP), European Medicines Agency (EMA) and NIH’s National Center for Advancing Translational Sciences (NCATS), the GSRS open-source software serves to make it easier for regulators and stakeholders to exchange information about substances which affect public health. By defining substances in a standardized format by assigning Unique Ingredient Identifiers (UNIIs), the GSRS supports faster regulatory submissions and enhances drug safety.
Data-centric drug submissions are soon likely to become compulsory, which we are already seeing with the EMA’s early adoption of the International Organization for Standardization’s (ISO) identification of medicinal products (IDMP) standards. These regulatory shifts mean it will no longer be optional for pharma companies and others involved in the supply chain to adhere to robust, harmonized data standards. Adopting the GSRS is one way to ensure substance data is stored and shared in a compliant way. Though many have used the platform, there is still some way to go before there is widespread adoption on a scale that will allow the whole industry to fully realize the intended cost, time, and safety benefits.
Pharma companies, governmental agencies, and non-government organizations must collaborate to address the barriers preventing the platform’s adoption and ensure that it is developed in a mutually beneficial direction. Here, we explore those challenges and suggest how a global consortium could guide GSRS’s development and fuel industry-wide adoption.
What is the GSRS?
The GSRS is a registry for substances, including information on their structure, how they are made, and their classification as chemical, protein, nucleic acid, polymer, structurally diverse, or mixture. While names of substances may vary across regulatory domains, countries, and regions, GSRS offers standardized scientific descriptions in line with the International Organization for Standardization ISO11238 standard.
The GSRS UIs provide a strong data backbone that is important for both regulators and the pharmaceutical company teams handling drug submissions.
The system also plays an important role in drug safety, especially during recalls. For example, in 2018, several commonly prescribed drugs were discovered to contain nitrosamine impurities, a probable carcinogen in certain forms. Investigations revealed the contamination likely stemmed from changes in manufacturing processes, involving certain solvents and reagents. With a centralized database like the GSRS that catalogs all substances and manufacturing processes, UNIIs manufacturers could trace contamination sources quickly and more accurately. The system thus facilitates better cross-border communication in recall situations, so regulators can rapidly alert stakeholders using standardized identifiers, minimizing recall delays.
Challenges Felt By All Involved – Regulators, Pharma, and Healthcare Institutions
Despite the benefits of GSRS, the platform and adoption of its data standards face barriers to widespread global implementation. The GSRS standards currently align with submission formats used by the FDA and EMA, but do not yet fully cover the requirements of other regulatory agencies, such as Japan’s Pharmaceuticals and Medical Devices Agency or Australia’s Therapeutic Goods Administration.
Another challenge is the practical adoption of GSRS. For pharmaceutical companies to embrace GSRS, they would have to prepare their data so that it can be imported into their local version of GSRS. While the GSRS provides flexibility in implementing the system, understanding all the components of GSRS is a learning curve. Transition to GSRS thus demands a considerable investment of time.
From the pharmaceutical industry’s perspective, GSRS is sometimes perceived as a platform “made by regulators, for regulators.” This perception leads to a sense that GSRS overlooks the needs and preferences of pharma companies in managing substance data. For example, there are concerns around intellectual property (IP) security. While the GSRS public dataset is kept separate from the version used internally by pharma companies, apprehension remains about proprietary information potentially being exposed through the system.
A Collaborative Consortium for GSRS
To address the current barriers to GSRS adoption, a stronger connection between pharmaceutical companies, regulators, and other healthcare institutions is needed. A collaborative approach could shape a unified vision for the GSRS, paving the way for globally harmonized regulatory systems.
The proposed governing body would focus on developing a shared direction for the GSRS, alongside a roadmap with actionable steps. These steps would support many aspects of implementation, from software development to the creation of a ‘help desk’ and GSRS documentation/ tutorials. Other key outcomes would include showcasing practical business use cases for the GSRS to encourage buy-in from senior stakeholders, and scalable governance and standards.
The consortium was first suggested by the NIH, FDA, and US Pharmacopeia and brought to the Pistoia Alliance due to its history in successfully managing collaborative, data-focused projects in life sciences and working with regulatory agencies worldwide. For example, the Alliance’s IDMP Ontology project was also developed to align with ISO standards on substance-related data. By fostering a community through workshops and pilot projects, the consortium aims to address both industry and regulatory needs, ultimately accelerating the GSRS’s adoption across the sector.
Shaping the Future of Substance Data: Join the GSRS Initiative
For GSRS to fulfill its vision of harmonized substance data, a broad range of expertise is needed, spanning pharmacology, data science, and regulatory fields. The industry must start adjusting and re aligning the platform now, to ensure the needs of both regulator and pharma companies are met before ISO standards and GSRS use become mandatory. It’s much easier for the industry to shape its future proactively than to adapt to a deadline.
The Pistoia Alliance now invites interested organizations and experts to come forward to build this new consortium, share ideas, and pledge funding: gsrsconsortium@pistoialliance.org.
Author Details
Dr. Birthe Nielsen, Project Manager, Pistoia Alliance
Publication Details
This article appeared in American Pharmaceutical Review:Vol. 28, No. 3
April 2025Pages: 8-9
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