GSRS Community

The GSRS Community unites regulators, industry, and technology partners to advance the quality, adoption, and worldwide use of the Global Substance Registration System (GSRS), the open-source substance registry maintained by the FDA and NCATS.

A community to advance use of GSRS worldwide

The mission of the GSRS Community is to advance the quality and use of GSRS worldwide as a registration system for the ingredients in medicinal products across multiple organizations. This initiative represents a critical opportunity to foster global cooperation, accelerate standardization, strengthen the reliability of regulatory data, and maximize the benefits of open data.

The GSRS Community of Interest provides a neutral, pre-competitive forum for regulators, industry, and technology partners to collaborate on advancing the quality, adoption, and practical use of GSRS through knowledge sharing, implementation support, and targeted collaborative activities.

What is the Global Substance Registration System (GSRS)?

Developed and maintained by the FDA and NCATS, the Global Substance Registration System (GSRS) is an open-source, API-driven platform that 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 Development Roadmap

The community’s work is guided by a shared roadmap for GSRS development, produced collaboratively by this community, the FDA, and other regulatory agencies. The roadmap sets out the platform’s planned direction, including modernizing the architecture, adding new capabilities, and improving data quality across upcoming releases.

Download the GSRS development roadmap

Please note that this roadmap is subject to change. Timelines and deliverables may be adjusted as circumstances evolve.

Who & Why

The GSRS Community is a global forum that invites engagement by:

Regulators and health authorities to help govern shared standards, so substance data stays consistent and exchangeable across agencies.
Pharma and industry teams to shape the direction of the GSRS and adopt one open and shared source of substance information.
Technology partners and vendors to innovate the integration of GSRS into the tools and services for pharma R&D today and into the future.