Global Substance Registration System

Project Charter

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 the ingredients in medicinal products.

The Challenge

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.

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.

What does the project aim to achieve?

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
NIH/NCATS
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.

The resulting deliverables will include:

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