Global Substance Registration System

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