All Artificial intelligence (AI) articles
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PodcastsRegRapPod − InConversation with Aman Khera
InConversation talks about opportunities and disruptors within the regulatory affairs industry with Aman Khera
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Industry newsEuropean Commission targets high-risk AI with new draft guidelines
The European Commission has published draft guidelines to help developers determine whether their artificial intelligence (AI) qualifies as ‘high-risk’ under Article 6 of the AI Act. For developers of AI-enabled medical devices, the stakes are particularly high.
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Industry newsThe HMA-EMA NDSG publishes report on AI in medicines development
Industry is bringing artificial intelligence (AI) to EU medicines regulators faster than ever before, with the number of new AI applications discussed with applicants as part of regulatory procedures having risen sharply, according to a new report by the Heads of Medicines Agencies (HMA) and the European Medicines ...
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Industry newsMHRA releases AI Airlock Phase 2 programme report
The AI Airlock Phase 2 Programme Report has been published by the MHRA, providing information on the insights and subsequent recommendations from Phase 2 of the initiative.
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Industry newsThe National Commission into the Regulation of AI in Healthcare releases survey findings
A summary of the findings from the UK National Commission into the Regulation of Artificial Intelligence in Healthcare’s Call for Evidence has been published, which highlights the need for a significant overhaul of the current framework.
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ContentsRegulatory Rapporteur June 2026 – Contents
The June issue of Regulatory Rapporteur focuses on lifecycle management.
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EditorialLifecycle management: Enhancing regulatory agility
Navigating complex regulatory requirements across multiple regions and dealing with fragmented data are common challenges for keeping marketing authorisations and technical files compliant. This June issue of Regulatory Rapporteur looks at how AI and advanced digital technologies can help by integrating data and generating predictive insights, enabling more proactive lifecycle management and time for innovation.
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JournalEnhancing post-market surveillance with Artificial Intelligence and predictive analytics
Fragmented data and manual review can limit the impact of PMS. Find out more about how AI, can modernise PMS workflows to improve early issue detection and support corrective actions, using a 20-year analysis of arthroscopic-device recalls to illustrate predictive analytics in practice.
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CommentaryThe future of regulatory affairs: From siloed structures to data-driven healthcare innovation
As biologicals, AI, combination products and personalised therapies continue to reshape healthcare, this article explores what models will define the future of the regulatory affairs profession.
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JournalTOPRA Annual Lecture 2026: The Global Imperative for Responsible AI in Healthcare
This article summarises the discussions at TOPRA’s Annual Lecture 2026, which focused on the responsible global govenance of AI in healthcare
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Industry newsMHRA invites Call for Evidence to assess AI regulation
This industry news update explains the reason for the MHRA’s Call for Evidence for AI regulation and provides guidance.
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Industry newsFDA and EMA publish guiding principles of good AI practice in drug development
This industry news updates shares the ten principles of best practice for AI.
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Journal2025 UK MDR Regulatory Conference: Meeting report
This article is a report of the 2025 UK MDR Regulatory Conference that was hosted by TOPRA and RAPS.
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JournalThe evolving role of the regulatory professional in the age of Artificial Intelligence
This article explores how artificial intelligence can be used across dossier preparation, CMC, clinical development and more.
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ContentsRegulatory Rapporteur January 2026 – Contents
The January issue of Regulatory Rapporteur focuses on complex products.
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EditorialNavigating complexity: Regulation at the interface of innovation, technology and confidence
This issue focuses on complex products, with articles on brain-computer interfaces, radiopharmaceuticals and sophisticated generic products, and explores how regulatory systems can remain robust and predictable while enabling novel technologies to reach patients.
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Journal2025 Regulatory Intelligence Conference Europe: Meeting report
This article summarises sessions from the TOPRA/RAPS 2025 Regulatory Intelligence Conference Europe.
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JournalIVD8: The hunt for evidence – An IVD perspective
This is a report of the IVD8 session that took place at this year’s Symposium.
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JournalIVD6: The evolution of the In Vitro Diagnostic Regulation
This is a report of the IVD6 session that took place at this year’s Symposium.
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JournalMD7: Updates on Artificial Intelligence legislation and policy
This is a report of the MD7 session that took place at this year’s Symposium.