{"id":455,"date":"2026-08-14T12:06:39","date_gmt":"2026-08-14T10:06:39","guid":{"rendered":"https:\/\/www.pqra.gr\/ai-in-the-medicines-lifecycle-what-eu-regulators-now-expect\/"},"modified":"2026-08-27T11:35:42","modified_gmt":"2026-08-27T09:35:42","slug":"ai-in-the-medicines-lifecycle-what-eu-regulators-now-expect","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/ai-in-the-medicines-lifecycle-what-eu-regulators-now-expect\/","title":{"rendered":"AI in the Medicines Lifecycle: What EU Regulators Now Expect"},"content":{"rendered":"<p style=\"font-size:19px;line-height:1.7;color:#33414d;\"><strong>Artificial intelligence has moved from the margins of drug development into the mainstream of discovery, clinical trials, manufacturing and pharmacovigilance. EU regulators have responded with a fast-growing body of expectations &mdash; the EMA&#8217;s reflection paper on AI, a multiannual regulatory workplan, and the horizontal EU AI Act. For marketing authorisation holders, the question is no longer whether to use AI, but how to use it in a way that will survive regulatory scrutiny.<\/strong><\/p>\n\n<h2>The EMA&#8217;s position: principles, not prohibition<\/h2>\n<p>The EMA set out its thinking in the <em>Reflection paper on the use of artificial intelligence in the medicinal product lifecycle<\/em> (EMA\/CHMP\/CVMP\/83833\/2023), issued in draft in July 2023 and adopted in final form in September 2024. It is not a binding guideline, but it is the clearest signal available of how European assessors will approach AI in a dossier.<\/p>\n<p>The central message is a <strong>risk-based approach<\/strong>. The level of regulatory scrutiny should be proportionate to the AI system&#8217;s potential impact on patient safety, data integrity and benefit-risk decision-making. A model used to triage internal research carries very different risk from one that informs a dosing algorithm or a batch-release decision. The reflection paper applies across the whole lifecycle: drug discovery, non-clinical development, clinical trials, manufacturing and post-authorisation safety.<\/p>\n\n<h2>What &#8220;good&#8221; looks like to an assessor<\/h2>\n<p>Read together, the EMA&#8217;s outputs point to a consistent set of expectations. Applicants and holders should be prepared to demonstrate:<\/p>\n<ul>\n<li><strong>Human oversight and accountability.<\/strong> The applicant remains responsible for AI-derived results; qualified people must be able to understand, challenge and override model outputs.<\/li>\n<li><strong>Data quality and integrity.<\/strong> Training and test data should be relevant, representative and free from unmanaged bias, with particular care where models influence precision-medicine decisions.<\/li>\n<li><strong>Transparency and traceability.<\/strong> Model development, validation and decision logic must be documented well enough for an assessor to follow.<\/li>\n<li><strong>Validation fit for intended use, with lifecycle monitoring.<\/strong> Performance must be validated against the intended purpose and then monitored over time, with controls for model drift and retraining.<\/li>\n<li><strong>Early regulatory dialogue.<\/strong> Where an AI methodology could have regulatory impact, the EMA encourages sponsors to seek scientific or qualification advice early rather than defending choices at assessment.<\/li>\n<\/ul>\n<p>The EMA has also published guiding principles on the use of large language models in regulatory work, stressing human oversight, governance and awareness of accuracy and &#8220;hallucination&#8221; risks &mdash; a useful barometer of the caution regulators expect around generative tools.<\/p>\n\n<h2>The EU AI Act adds a second, binding layer<\/h2>\n<p>Alongside the EMA&#8217;s science-based guidance sits hard law. The EU AI Act (Regulation (EU) 2024\/1689) entered into force on 1 August 2024 and applies in phases: prohibited AI practices and AI-literacy duties from February 2025, obligations for general-purpose AI models from August 2025, and the core high-risk rules from August 2026, with product-embedded high-risk systems following in 2027.<\/p>\n<p>The Act uses a four-tier, risk-based classification: unacceptable (banned), high-risk, limited-risk (transparency duties) and minimal-risk. Crucially for life sciences, an AI system is <strong>high-risk<\/strong> where it is a safety component of &mdash; or is itself &mdash; a product covered by EU harmonisation legislation such as the Medical Device Regulation (MDR) or IVDR, and that product must undergo notified-body conformity assessment. In practice, AI-based software qualifying as a medical device in the higher MDR\/IVDR risk classes will generally be treated as high-risk under the AI Act, triggering obligations on risk management, data governance, technical documentation, human oversight and post-market monitoring. The Medical Device Coordination Group has issued guidance (MDCG 2025-6) on how the two frameworks interact.<\/p>\n<p>One moving part worth watching: the Commission has proposed a &#8220;digital omnibus&#8221; simplification that would postpone some high-risk AI Act deadlines and tie them to the readiness of harmonised standards. That proposal was still working through the legislative process in 2026, so the timeline should be treated as liable to change rather than settled.<\/p>\n\n<h2>Medicines versus devices: know which regime bites<\/h2>\n<p>A recurring source of confusion is that medicines themselves are not regulated as &#8220;high-risk AI.&#8221; AI used <em>within<\/em> the medicine lifecycle is addressed through the EMA&#8217;s science guidance and the general pharmaceutical framework. The AI Act bites directly when there is a device or general-purpose AI component in play. Many real products &mdash; a digital companion diagnostic, an AI-enabled delivery device, a clinical-decision-support tool &mdash; sit across both regimes at once, and the compliance strategy has to reflect that overlap rather than treating each in isolation.<\/p>\n\n<h2>How PQRA helps<\/h2>\n<p>PQRA helps marketing authorisation holders and device manufacturers turn these overlapping expectations into a practical plan: classifying AI use cases by regulatory impact, preparing the documentation and validation evidence assessors expect, mapping where the AI Act applies alongside the MDR or IVDR, and framing early scientific-advice or qualification requests to the EMA. The goal is to adopt AI confidently &mdash; with the governance in place to defend it.<\/p>\n\n<p>To discuss how the EMA&#8217;s AI expectations and the EU AI Act affect your development or device portfolio, <a href=\"\/el\/contact\/\">get in touch with the PQRA team<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"<p>Artificial intelligence has moved from the margins of drug development into the mainstream of discovery, clinical trials, manufacturing and pharmacovigilance. EU regulators have responded with a fast-growing body of expectations &mdash; the EMA&#8217;s reflection paper on AI, a multiannual regulatory workplan, and the horizontal EU AI Act. For marketing authorisation holders, the question is no [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":456,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"saved_in_kubio":false,"_swpsp_post_exclude":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-455","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>AI in the Medicines Lifecycle: What EU Regulators Now Expect - PQRA<\/title>\n<meta name=\"description\" content=\"Artificial intelligence has moved from the margins of drug development into the mainstream of discovery, clinical trials, manufacturing\u2026\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.pqra.gr\/el\/ai-in-the-medicines-lifecycle-what-eu-regulators-now-expect\/\" \/>\n<meta property=\"og:locale\" content=\"el_GR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"AI in the Medicines Lifecycle: What EU Regulators Now Expect - 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