Why is this important?
The European Medicines Agency (EMA) will be the first health agency to mandate compliance with ISO IDMP (Q1, 2023), with the FDA not far behind. Governance of essential IDMP standards and implementations is not assigned to a specific, overarching governing body. Diverging implementations of IDMP across geographical regions and jurisdictional domains are already causing inconsistencies in the interpretation across implementing organizations. Given that there is no semantic alignment between regulatory bodies, there exists a risk that regulatory compliance needs will lead to large integration and interoperability costs and that the benefits from IDMP in drug safety, innovation, and other areas will not be fully realized. Rather than concentrating on the discovery of new medicines, organizations will be struggling with data issues, e.g., the need to map product data across the organization, throughout the product lifecycle.
What will the project achieve?
Due to our robust framework for pre-competitive collaboration. the Pistoia Alliance was selected to manage this initiative with the goal of creating a minimal viable product (MVP) ontology that demonstrates added value to the ISO IDMP standards for data usability across organizational boundaries and regulatory jurisdictions. We have pulled together a core team consisting of Pharmaceutical stakeholders, regulatory bodies, standards organizations, non-profit groups, and solutions providers for this project.
The key success factors for the project include:
- Phase 1 implementation of a quality MVP that can be used by pharmaceutical companies and others.
- Demonstration of the usability and added value of the ontology, which will be the foundation to obtain investment for the next phase of the project to build out the ontology more fully.
- Demonstration of governance capabilities.
- Open communication with all relevant stakeholders with results being shared openly.