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Industry newsSaudi FDA vision to be a leading regulator includes updating guidance on combination products
This industry news updates shares Saudi FDA’s updated guidance for combination products.
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Industry newsEC proposes regulation to simplify rules on medical and in vitro diagnostic devices
This industry news update shares the EC’saim to simplify medical and IVD device rules through a new proposal.
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Industry newsThe VMD changes how it calculates adverse events incidents for animals
This industry news update shares the VMD’s changes to how it calculates adverse events, which has now taken full effect.
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Industry newsDARWIN EU reaches more than 100 research studies
This industry news update shares a major milestone for DARWIN EU that has reached more than 100 research studies.
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Industry newsEMA launches #ItTakesATeam campaign to address medicine shortages
This industry news update explains the #ItTakesATeam campaign which aims to raise awareness of medicine shortages.
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Industry newsMHRA advances new reform for the treatment of rare diseases
This industry news update explores the MHRA’s upcoming framework that addresses treatments related to rare diseases.
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Industry newsEMA ETF offers scientific advice for antimicrobial resistance
This is an industry news update about the EMA’s ETF that offers scientific advice for antimicrobial resistance.
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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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Industry newsNICE reviews health technology assessment to better support patients
This industry news update shares NICE’s plans to review how health technologies are evaluated.
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Industry newsRegulatory Rapporteur is back in PDF format
News of an exciting new development for Regulatory Rapporteur starting in October 2025.
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Industry newsMHRA cross-agency team outlines emerging considerations for the manufacture of personalised medicines
This industry news update shares the MHRA’s guidance for the manufacture of personalised medicines.
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Industry newsAI Airlock: Growing the future of artificial intelligence technology in healthcare
This industry news update is about the ongoing projects as a part of AI Airlock led by the MHRA.
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Industry newsNICE increases access to SGLT-2 inhibitors medicines to help treat type 2 diabetes
This industry news update is on SGLT-2 inhibitors that NICE are expanding access for as an alternative treatment for type 2 diabetes.
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Industry newsSurvey shapes Regulatory Rapporteur’s future plans
An update on how readers’ feedback is informing future developments for Regulatory Rapporteur.
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Industry newsEFPIA publishes guidance document to help support novel methodology submissions
This industry news update shares the EFPIA’s guidance document to help support the submission process for novel methodologies.
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Industry newsNew Director appointed at the FDA’s Center for Drug Evaluation and Research
This industry news update discusses George Francis Tidmarsh, M.D., Ph.D., who has been appointed as Director of the Center for Drug Evaluation and Research.
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Industry newsFDA makes labelling changes to opioid products mandatory
This industry news update shares the FDA’s labelling requirements for opioid products and what changes must be applied.
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Industry newsEMA publishes workplan on how to harness data and AI for public health
This industry news update discusses the EMA’s workplan on how to use data and AI to improve public health.
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Industry newsEMA and ICH call for more real-world evidence in regulatory practices
This industry news update explores the growing need for more real-world evidence and real-world data.