The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have jointly published a set of ten common principles aimed at guiding the use of artificial intelligence (AI) in the development of medicines.This initiative comes as the adoption of AI technologies among biopharmaceutical companies accelerates, significantly altering traditional practices across the entire product lifecycle, from drug discovery to clinical testing and commercial rollout.
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pharmaphorum.comThe principles are designed to underpin future guidance on AI in both the US and EU, supporting international standard-setting in the field.They provide broad guidance on the use of AI in evidence generation and monitoring throughout all phases of a medicine's lifecycle, including early research, clinical trials, manufacturing, and safety monitoring.
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pharmaphorum.comAt the forefront of these principles is the requirement that AI systems must be human-centric by design and align with ethical values.This means that AI technologies should be developed using a risk-based approach that considers the context of their use, while adhering to existing legal, ethical, technical, scientific, cybersecurity, and regulatory standards.
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pharmaphorum.comMoreover, the principles emphasize the importance of having a clear context of use for AI systems.They should be developed with multidisciplinary expertise and under strict data governance and documentation controls, particularly concerning privacy and the protection of sensitive data.Best practices in model and system design, as well as software engineering, are also highlighted as essential components of responsible AI development.
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pharmaphorum.comRisk-based performance assessments are mandated, which include testing human-AI interactions before the systems can be deployed.Ongoing monitoring and periodic re-evaluation are necessary to ensure that these AI systems remain fit for their intended purposes.Additionally, the regulators stress the need for AI outputs to be communicated in plain language that is clear, accessible, and contextually relevant to users and patients.
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pharmaphorum.comThe EMA and FDA's collaborative effort reflects a broader commitment to managing the risks associated with AI technologies while harnessing their potential benefits.As noted by Olivér Várhelyi, European Commissioner for Health and Animal Welfare, these guiding principles represent a renewed cooperation between the EU and the US in the realm of novel medical technologies.He emphasized that this collaboration is crucial for maintaining leadership in global innovation while ensuring the highest levels of patient safety.
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pharmaphorum.comThe rapid integration of AI in the biopharmaceutical industry is evident from the increasing frequency of partnerships between biopharma companies and AI specialists.Recent collaborations include Iktos with Servier and Pierre Fabre, Insilico Medicines with Servier, and GSK with Noetik and Helix.Additionally, AstraZeneca has acquired Boston-based Modella AI to enhance its research and development operations through advanced AI capabilities.
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pharmaphorum.comAs AI continues to evolve, the EMA and FDA's principles will serve as a foundational framework for the responsible use of these technologies in medicine.This proactive approach aims to ensure that AI not only accelerates innovation but also prioritizes patient safety and regulatory compliance throughout the drug development process.
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ema.europa.eufda.govIn conclusion, the establishment of these common principles marks a significant step towards integrating AI into the healthcare landscape responsibly.By fostering collaboration and setting clear guidelines, the EMA and FDA are paving the way for a future where AI can enhance the efficacy and safety of medical products while addressing the ethical considerations inherent in their use.
