The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have jointly established ten guiding principles for the use of artificial intelligence (AI) in the medicine lifecycle, a significant step toward regulatory alignment in drug development across major markets.
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ddw-online.comappliedclinicaltrialsonline.comThis initiative is expected to enhance international collaboration among regulatory bodies, organizations, and stakeholders involved in pharmaceuticals.
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appliedclinicaltrialsonline.comThe principles encompass a broad range of applications, providing guidance on AI's role in evidence generation and monitoring throughout the stages of drug development—from early research and clinical trials to manufacturing and post-market safety surveillance.
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ddw-online.comappliedclinicaltrialsonline.comAccording to Olivér Várhelyi, European Commissioner for Health and Animal Welfare, these principles mark a renewed cooperation between the EU and the US in novel medical technologies, aiming to maintain a leading role in global innovation while ensuring high patient safety standards.
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ddw-online.comhealthpolicy-watch.newsThe recent increase in AI adoption in the pharmaceutical sector has prompted regulators to shift from mere oversight to establishing a principles-based framework.
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ema.europa.eutmf-ev.deThe EMA and FDA's initiative follows previous collaborative efforts, particularly after a bilateral meeting in April 2024, which highlighted the need for coherent regulations in the face of rapid technological advancements.
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tmf-ev.dehealthpolicy-watch.newsAI technologies have shown great promise in accelerating the development of safe and effective medicines, as outlined in the European Commission's Biotech Act proposal.
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ema.europa.euHowever, leveraging these technologies requires meticulous management to mitigate risks associated with their use.
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ema.europa.euBy establishing these principles, both agencies aim to provide a solid foundation that supports responsible AI adoption while ensuring compliance with ethical and regulatory standards.
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appliedclinicaltrialsonline.comThe ten guiding principles emphasize a human-centric, risk-based approach to AI integration.Key components include clear definitions of AI's context of use, adherence to applicable standards, and robust data governance.
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appliedclinicaltrialsonline.comtmf-ev.deFurthermore, the principles call for multidisciplinary expertise, transparent model development practices, and continuous performance monitoring to address concerns such as "data drift," which can affect AI performance over time.
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healthpolicy-watch.newsIndustry associations have welcomed this landmark accord, recognizing it as a crucial step toward harmonizing regulations between the EU and US and enhancing the accountability and integrity of AI applications in drug development.
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healthpolicy-watch.newsHowever, they also stress the need for more concrete measures to ensure effective implementation of these principles across both regions.
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healthpolicy-watch.newsThe EMA and FDA have made it clear that these principles are not prescriptive requirements but rather a framework intended to evolve with the technology.
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appliedclinicaltrialsonline.comAs AI continues to advance, the agencies plan to supplement these principles with additional guidance reflecting emerging use cases and scientific progress.
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ddw-online.comtmf-ev.deThis ongoing development will include the exploration of opportunities for global convergence on AI-related topics in collaboration with international public health partners, aiming to foster responsible innovation in drug development.
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ema.europa.euappliedclinicaltrialsonline.comIn conclusion, the establishment of joint AI principles by the EMA and FDA represents a pivotal moment in the regulatory landscape of drug development.By fostering collaboration and setting clear guidelines, these agencies are taking significant steps to ensure that AI can be safely and effectively integrated into the pharmaceutical industry, ultimately benefiting patient safety and enhancing therapeutic innovations.
