All Europe articles – Page 2
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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.
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Industry newsMHRA cuts approval times for UK clinical trials in half
This industry news update announces the MHRA’s decision to reduce clinical trial approvals from 91 days to 41 days.
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JournalMaximising regulatory success through early EMA engagement in drug development
This article explores the importance of early regulatory engagement with the EMA and some tools, guidance and procedures on offer.
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JournalElectronic patient information: Results of the e-PIL pilot from Belgium and Luxembourg hospitals
This article discusses the 2018 e-PIL pilot in Belgium and Luxembourg including the paper and electronic versions of the patient information leaflet.
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Journal What could the future of labelling look like? The Gravitate-Health story
This article introduces the Gravitate-Health digital lens concept and talks about the value of ePI to help understand patient needs.
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JournalThe EMA/NCA electronic product information initiative: Engagement, implementation and vision for the future
This interview with Juan García Burgos discusses the upcoming EMA/National Competent Authority electronic product information (ePI) initiative.
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JournalTranslating real-world needs into digital medication tools: Good practices for co-creation with patients
This article discusses the importance of patient engagement in digital health tool development, using the case study of the Gravitate-Health project.
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JournalDiversity in clinical research: Regulatory considerations and updates
This article explores how to improve diversity and patient representation in clinical trials and looks at guidance from the EMA.
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JournalThe importance of patient advocacy in the EMA ODD process
This article discusses the role of patient advocacy groups in the orphan drug designation process to incoporate more patient-centred approaches.
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JournalPatient involvement in the regulatory area: Insights into national level dialogues
This article explores the different areas of patient involvement in European NCA regulatory processes.
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JournalRealising opportunities to generate RWE for regulatory decisions through randomised pragmatic trials
This article summarises key features of the EFPIA paper and discusses how randomised pragmatic trials can be used to aid regulatory decision-making.
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