Global Substance Registration System (GSRS) Consortia

Date Submitted: 20 September 2023

Person Creating Document: Hall Gregg and Becky Upton

Idea Originator: NIH, FDA, US Pharmacopeia

Strategic Priority: Deliver Data-Driven Value at Scale

Problem Statement

The GSRS is a registration system for the ingredients in medicinal products. The creation of the GSRS was a collaborative effort between the FDA, NIH and EMA, and driven by the need to accurately track the global supply chain of ingredients in regulated products. The goal of the system is to make 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.
In practice, the system serves a multiplicity of use cases beyond providing a standard substance registry, and there is limited stakeholder governance to guide ongoing and future system development, and to provide financial stability.

Idea Proposal and Value Proposition

In order to address the current challenges with the GSRS system, and to build a vision for the future that could include the harmonisation of regulatory systems, the proposal is to create a consortium of GSRS stakeholders led by the Pistoia Alliance.
The proposed Consortia would form the governing body for the GSRS. The mission of the Consortia would be to develop a shared vision for GSRS, develop and enact a business plan to attain the vision, and guide ongoing development and maintenance of the system.
The consortia should, at a minimum, include stakeholders from:

● Pharmaceutical companies
● Health Authorities including, but ideally not limited to the FDA and EMA
● US Pharmacopeia
The multi-year vision, strategy and business plan should include the:
● As is state of the GSRS and the vision for the future
● Viable governance framework
● Business model with a sustainable funding mechanism
● Architectural analysis
● Process for release management including testing, documentation, release schedules, implementation and support guides
● Support models
● Alignment on standards, terminologies and minimum metadata requirements.
We propose initiating a multi-stakeholder project to define the multi-year strategy, vision and governance framework, and to determine if there is a viable business model to sustain the Consortia.

Critical Success Factors

● Development of a business case that meets the needs of all primary stakeholders with a viable funding model for development and maintenance of the system
● Agreement on a governance approach that balances immediate and long-term needs and delivers value to all stakeholders
● A governance, development model and system architecture that works with in today’s fast changing business, regulatory and technology environments

Preliminary Funding Request

The effort would be divided into two phases.
In Phase 1, the Pistoia Alliance would:

  1. Complete interviews with key stakeholders to confirm the scope of a potential consortium effort
  2. Form and run a working group of stakeholders to define business case, governance framework and financial model for the GSRS
  3. Based on the developed vision, business case and governance framework, work to secure the proposed funding to launch the consortia

The estimated cost for Phase 1 is $60K and the estimated time frame is 9-12 months.
Phase 2 would be the official launch, stand-up and running of the consortia. Costs and timelines would be developed in Phase 1.