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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 newsFDA launches final guidance on therapeutic equivalence evaluations
The US Food and Drug Administration (FDA) has issued its final guidance on making therapeutic equivalence evaluations and assigning therapeutic equivalence (TE) codes.
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Industry newsFDA consults on the regulation of GenAI-enabled medical devices
The US Food and Drug Administration (FDA) has released a discussion paper to gather feedback on topics relevant to the regulation of generative artificial intelligence (GenAI)-enabled medical devices.
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Industry newsFDA finalises guidance aimed at widening access to cancer clinical trials
The US Food and Drug Administration (FDA) has finalised two guidance documents designed to help sponsors, Institutional Review Boards (IRBs) and investigators stop unnecessarily excluding cancer patients from clinical trials.
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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 newsFDA launches new guidance on development of psychedelic drugs to treat medical conditions
The US Food and Drug Administration (FDA) has issued its final guidance for drug development programmes evaluating the therapeutic potential of psychedelic drugs.
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Industry newsUSP 2025 Annual Drug Shortages Report: Shortages decline but duration increases
In June 2026, the United States Pharmacopeia (USP) released their 2025 Annual Drug Shortages Report, reviewing trends in drug shortages affecting the United States.
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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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Industry newsFDA launches Operation TrialBlazer to accelerate US clinical research
The US Food and Drug Administration (FDA) has announced plans to revitalise clinical research in the USA, as part of a US Department of Health and Human Services (HHS) initiative titled ‘Operation TrialBlazer’. The FDA has proposed multiple actions to achieve this aim, targeting both early- and late-stage ...
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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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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 ...