EFPIA Calls for Clearer AI Governance to Safely Transform Drug Development

Regulatory agencies have emphasized the need for trustworthy and explainable AI; however, while current regulatory guidelines lay the groundwork for AI governance, greater clarity is needed on how AI should be governed throughout its lifecycle.

This is according to the latest report released by the European Federation of Pharmaceutical Industries and Associations (EFPIA ) on Tuesday, which presents its assessment of preliminary policy considerations for European regulators.

EFPIA calls for lifecycle governance, regulatory harmonization, and industry dialogue to ensure safe and effective AI integration in drug development

This report, they assert, “offers real-world perspectives from pharmaceutical leaders, based on structured interviews about AI risk and governance, drawing on international best practices from various sectors.” Among the institutions consulted were the OECD, NIST, ISO, IEC, and ENISA. The goal is “to articulate the opportunities and challenges that regulators could leverage to develop new guidelines on AI.”

This report presents a cross-sectoral perspective on how AI governance can be effectively integrated into drug research and development (R&D) and post-authorization processes, with the aim of ensuring trust, transparency and regulatory harmonization through ongoing dialogue between industry and regulatory bodies.

EFPIA considers a series of measures essential to “complement governance findings and support responsible innovation”

First, Efpia sees a need to “clarify the scope and application of AI-related exemptions,” and cites as a specific example the exemption for scientific R&D in the EU AI Act , including the possibility of conducting clinical trials by putting products into service before CE marking.

It also considers it necessary to foster iterative dialogue and collaboration opportunities between regulatory bodies and industry on AI policy issues, with transparency through greater sharing of AI use cases and governance strategies.

On the other hand, EFPIA see it as necessary to “support regulatory efforts to collaborate and harmonize, whenever possible, expectations for AI, and to consider the use of regulatory testing environments to explore AI use cases and industry-led governance solutions.”

Finally, they also value the integration of AI oversight into existing regulatory frameworks, such as the qualification/validation of endpoints for AI-based imaging and RWE processes for AI-generated synthetic controls, to ensure consistency, efficiency, and trust.

In summary, EFPIA believes that “AI has the potential to revolutionize drug development, enabling smarter and more efficient development processes. However, to achieve this potential, trust is required, both in the technology and in the processes that govern it.”

Therefore, EFPIA believe that “integrating governance throughout the AI ​​lifecycle can help pharmaceutical companies ensure that its use is effective and, at the same time, ethically compliant with constantly evolving regulatory standards.”

This report will serve as a basis for further dialogue between industry and policymakers on appropriate regulatory and governance frameworks, based on industry experience.

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First published in diariofarma. A third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.

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