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JournalNavigating Advanced Therapy Medicinal Product regulatory changes: European Medicines Agency and UK guidance updates
This article summarises the implications of the EMA unified guideline, the UK-Post Windsor Framework guidance and proposed revisions to the EU Good Manufacturing Practice Part IV.
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JournalNew European Medicines Agency fees: The effect on veterinary medicines
In response to the EMA’s new fee system, this article dicusses the impact on marketing authorisation holders who place veterinary medicines on the market.
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JournalA key role for the European Medicines Agency in the European Union’s Health Technology Assessment Regulation
Regulatory Rapporteur June 2024 | Volume 21 | No.6 Abstract The need for early collaboration between regulators and European Union’s (EU) Health Technology Assessment (HTA) bodies when developing ‘fit-for-purpose’ evidence generation plans has long been acknowledged, and the ...
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Industry newsEMA to address antimicrobial resistance risks from veterinary medicinal products
The European Medicines Agency (EMA) has published a new concept paper outlining plans to assess the risks of humans developing AMR from VMPs via the environment.
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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 newsEMA accepts new guidelines on investigational ATMPs
The European Medicines Agency (EMA) has adopted the Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials, which officially comes into effect on 1 July 2025.
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Industry newsEMA establishes new standard procedure for high-risk medical devices
The European Medicines Agency (EMA) has established a standard procedure for manufacturers of high-risk Class III and Class IIb medical devices to request scientific advice.
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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 newsRui Santos Ivo elected as new Chair of the EMA Management Board
Rui Santos Ivo has been elected as the new Chair of the European Medicines Agency (EMA) Management Board. Mr Santos Ivo takes over from Lorraine Nolan, who completed her tenure on 21 March 2025.
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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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