All Europe articles
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CommentaryMedical Device Regulation 2.0: Why stakeholder disagreement is bad for all
Proposals for MDR 2.0, published in December 2025, have exposed deep divisions across the EU medical devices community. This thought leadership article argues that, without genuine stakeholder consensus and structural reform, history risks repeating itself, with serious consequences for patients and industry alike.
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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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Industry newsEMA recommends marketing authorisation extension for Wegovy tablets
The European Medicines Agency (EMA) has endorsed an extension to the marketing authorisation of Wegovy (semaglutide) in the EU for weight management. The extension enables the use of tablets, making it the first glucagon-like peptide (GLP-1) receptor agonist for weight management developed for oral use.
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JournalConsiderations in building and maintaining regulatory intelligence
Rising regulatory volume, cross-jurisdictional variation and resource pressures make regulatory intelligence increasingly critical. Explore how AI and technology can support smarter monitoring, planning and risk management.
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JournalFrom gatekeepers to collaborators: Regulatory evolution toward risk-based lifecycle approaches in an era of innovation
Rapid advances in AI, software and drug discovery are reshaping regulation. This article challenges the view that regulation hinders innovation, framing it as a collaborative, risk-based partnership with real-world examples from AI diagnostics, in silico methods and medical device tools.
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JournalDriving efficiencies in global submissions through RIMS: Practical perspectives from industry
Manual processes are holding many teams back. Using a case study on complex EU procedures, this article explores how RIMS can help build future-ready regulatory functions.
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JournalNavigating divergence: Practical lessons from the UK lifecycle management of licences
Four case studies demonstrate how marketing authorisation holders can optimise UK lifecycle strategy through the strategic use of national routes, the International Recognition Procedure and parallel submissions, despite increasing EU-UK regulatory divergence.
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Industry newsHarmonisation, fast track and reliance activities in focus at recent EDQM meetings
Leaders from the European Directorate for the Quality of Medicines & HealthCare (EDQM), which is home to the European Pharmacopoeia (PhEur), participated in two public outreach events in May 2026. The first was on pharmacopoeial harmonisation in collaboration with United States Pharmacopoeia (USP), and the second on fast ...
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Industry newsEMA launches pilot to support breakthrough medical devices
The European Medicines Agency (EMA) has launched a pilot programme to support the development of breakthrough medical devices in the EU. This tests a new regulatory pathway that supports patient access to highly innovative technologies while maintaining rigorous safety and performance standards and will offer enhanced support for ...
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Industry newsGene therapies, first-in-class medicines and label updates: CHMP delivers a busy April session
The Committee for Medicinal Products for Human Use’s April 2026 session covered significant ground, making fourteen positive decisions in four days. The outcomes have direct implications for lifecycle managers and regulatory teams across the EU.
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Industry newsMHRA publishes draft 2026 medical device regulations for GB market
Regulatory pathways for medical devices in Great Britain are set for further change, following the publication of new pre-market requirements by the Medicines and Healthcare products Regulatory Agency (MHRA). The proposals introduce new measures on reliance, traceability and classification as part of the evolving post-Brexit regulatory framework.
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Industry newsCVMP advances discussions on AMR and quality guidance
During the April 2026 session, the European Medicines Agency’s (EMA) Committee for Veterinary Medicinal Products (CVMP) addressed a range of regulatory and scientific topics covering authorised products, pharmacovigilance, antimicrobial resistance (AMR) and ongoing guideline development.
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Industry newsClinical trials amendment regulations to take effect from 28 April 2026
The UK will implement its major clinical trials regulatory overhaul on 28 April 2026, introducing faster approvals and a more flexible, risk-based system, although some areas of regulatory and ethical alignment still require careful consideration.
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JournalPlain language results in UK clinical trials: Navigating new regulatory requirements and practical challenges
This analysis examines the new regulatory requirements for providing plain language summaries of trial results to participants, outlines operational challenges and offers practical recommendations for compliance with the HRA’s transparency framework.
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JournalThe regulatory valuation of patient experience data in rare diseases: A review of FDA and EMA labelling outcomes and methodological determinants
This article summarises a review carried out to evaluate patient experience data inclusion in regulatory assessements and labelling for rare diseases in the EU and the US
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Industry newsACT EU issues draft guidance on clinical trials during emergencies
Accelerating Clinical Trials in the EU (ACT EU) has issued new draft guidance that outlines clinical trial conduct during public health emergencies (PHEs). Public consultation is open until 30 April 2026.
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Industry newsEMA launches #HealthNotHype campaign
This industry news update shares the EMA’s new social media campaign to raise awareness for GLP-1 medicines.