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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 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 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 #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 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 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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JournalCross-functional strategies in clinical data disclosure for EMA Policy 0070 and Health Canada PRCI
This article discusses the requirements of clinical data transparency particularly in relation to the EMA Policy 0070 and HC PRCI.
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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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