The increasing integration of Artificial Intelligence (AI) within pharmaceutical and biotechnology sectors necessitates a robust regulatory framework to guide its application. Industry leaders and regulatory bodies convened at the HMA-EMA joint Network Data Steering Group meeting to address this significant development in drug development and data management. This assembly, held on 6 October 2025, spotlighted collaborative efforts between European agencies and counterparts such as the US FDA, focusing on AI and data frameworks essential for advancing healthcare innovations effectively and safely.
Advancing AI in Drug Development
The session commenced with Joerg Zinserling from BfArM sharing the final draft of the Guiding Principles of Good AI Practice in Drug Development. These guiding principles, co-authored with the FDA, aim to streamline AI terminology and applications across the pharmaceutical lifecycle. Recognizing the significance of global cooperation, the session discussed the necessity for consensus on AI terminology to foster seamless operational standards. An imminent publication date for these principles was announced, with further readiness for presentation at the ICMRA summit later this month.
Data Standardisation and Patient Registry Integration
A pivotal part of the meeting focused on enhancing data standardisation strategies led by Nick Halsey of EMA. Emphasizing a practical framework-based strategy, tangible changes aim to synchronize stakeholders while demonstrating resource allocations and highlighting key process necessities. Kelly Plueschke proceeded with delineating the HMA/EMA approach to integrating patient registries into regulatory frameworks, revealing a strategic plan that includes guidance, stakeholder engagement, and evidence-backed studies. Specialized focus groups and training resources are in pipeline to augment regulatory compliance in registries.
Key points discussed were:
- Establishing a refined EMRN data standardization framework is crucial for streamlined processes.
- Stakeholder engagement and training in AI and patient registries are vital for holistic integration.
- Alignment between EMA, HMA, and other entities like FDA strengthens regulatory consistency.
Participants underscored the need for ongoing collaboration and feedback to refine strategies, ensuring that regulatory practices stay ahead of technological advancements. The assembly determined the importance of creating dedicated guidelines to foster this integration, optimizing clinical trials and patient engagement efforts.
The pursuit of efficient data handling and AI applications in drug development highlights the need for continuous regulatory evolution. As the EMA and HMA drive forward, they stay attuned to the dynamic landscape of AI, ever-mindful of the necessity to balance innovation with patient safety. For individuals engaging in pharmaceuticals and biotechnologies, understanding these guidelines and actively participating in forthcoming training initiatives will empower their roles in shaping a future marked by precision medicine and enhanced regulatory oversight.
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