All Europe articles
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Industry newsUK confirms indefinite recognition of CE-marked medical devices
The UK government has confirmed that Great Britain will recognise CE-marked medical devices and in vitro diagnostic devices indefinitely, removing the prospect of a mandatory additional approval route for products already authorised for the EU market.
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JournalCOMBINE EU pilots: Roche’s experience as first pilot participants
Drawing on two successfully approved COMBINE pilot combined studies, this article shares practical experience of coordinated submissions and assessments, highlighting the benefits, operational challenges and potential solutions for making cross-regulation studies more efficient.
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JournalMultistakeholder collaboration to translate the ICH GCP E6(R3) guideline into Finnish: Supporting clinical trial conduct in Finland
This article summarises the process and outcomes of the ICH GCP E6(R3) translation and terminology project, an example of multistakeholder collaboration to advance a shared understanding of a well-established international guideline in a national context
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Industry newsEMA launches new pre-submission interactions model pilot
Beginning in September 2026, the European Medicines Agency (EMA) has invited marketing authorisation applicants to participate in an 18-month pre-submission interactions (PSI) model pilot.
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Industry newsNew diabetes treatment and a Vetmedin referral: Inside the CVMP July 2026 meeting
The July meeting of the Committee for Veterinary Medicinal Products (CVMP) covered product opinions, a Union referral, scientific advice outcomes, and several guideline updates spanning fixed combinations, novel RNA-based therapies and pharmacovigilance.
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Industry newsCHMP July meeting brings first-of-its-kind eye implant and oral psoriasis breakthrough
At its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended 12 new medicines for marketing authorisation (three generics, one biosimilar, and eight extensions of indication), while issuing negative opinions on three applications.
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Industry newsCVMP June 2026 meeting update: Vaccines, guideline reviews and an AMR strategy refresh
The Committee for Veterinary Medicinal Products (CVMP) met on 16-18 June 2026. Alongside its usual product decisions, the Committee advanced two guideline reviews for sponsors working on vaccines and other immunological products.
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Industry newsEU roadmap sets out 22 actions to phase out animal testing in chemical safety assessment
The European Commission has released a long-awaited roadmap towards phasing out animal testing for chemical safety assessments, having pledged to develop such an initiative in response to the European citizen’s initiative titled ‘Save Cruelty-Free Cosmetics – Commit to a Europe Without Animal Testing’, which was submitted to the ...
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Industry newsNew MHRA framework sets out IMA pathway for rare disease therapies
The MHRA has revealed its draft rare disease framework, open for consultation until 30 July. The current development model does not always suit the conditions for rare diseases as they require greater flexibility in how they are evaluated. The framework emphasises earlier engagement with regulators, flexible evidence requirements, ...
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Industry newsFAST-EU pilot delivers first results: 70-Day approval timelines prove feasible ahead of Biotech Act
The first results from the Facilitating and Accelerating Strategic Clinical Trials in the EU (FAST-EU) Pilot programme have been published by the Heads of Medicine Agency (HMA). Initial results indicate strong interest and engagement from stakeholders and the possibility of a 70-calendar-day approval timeline for clinical trial ...
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Industry newsEuropean Commission publishes first joint clinical assessment under EU HTA regulation
The European Commission released the first joint clinical assessment (JCA) report on 9 June for the orphan medicine tovorafenib (Ojemda®), developed by Ipsen, used to treat paediatric low-grade glioma (a type of brain tumour), after being endorsed by all member states. This marks an important milestone for European ...
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ContentsRegulatory Rapporteur July/August 2026 – Contents
The July/August issue of Regulatory Rapporteur focuses on therapeutics.
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JournalDrug development and regulatory pathways across therapeutic areas
This article evaluates how drug development and regulatory pathways differ across oncology, rare diseases, paediatric indications and life-threatening conditions in the US, UK and EU. Drawing on regulatory guidance and industry practices, it explores how therapeutic context shapes development, trial design and approval strategies, highlighting key differences in regulatory expectations and acceleration incentives.
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JournalEnvironmental risk assessment of human medicinal products in the EU: Legacy APIs, data reuse, and the governance bottleneck after the 2024 guideline revision
The 2024 revision of the EU environmental risk assessment (ERA) guideline extended requirements to all new marketing authorisation applications, including generics and hybrids. This article discusses the obstacles in pharmaceutical ERA, and the implications for regulatory efficiency, environmental protection, ethical use and the potential for improved ERA data reuse.
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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.