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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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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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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 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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JournalThe importance of patient advocacy in the EMA ODD process
This article discusses the role of patient advocacy groups in the orphan drug designation process to incoporate more patient-centred approaches.
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Industry newsUse of new EMA platform for monitoring medicine shortages to become mandatory
The European Medicines Agency (EMA) has launched the European Shortages Monitoring Platform (ESMP), aimed at preventing and managing shortages of centrally authorised products (CAPs).
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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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JournalVeterinary Regulation 2019/6: Impact, challenges and the future: Interview with Ivo Claassen
In this interview, Claire McDermott talks with Ivo Classen, Head of the Veterinary Medicines Division and Deputy Executive Director of the European Medicines Agency on the impact of Veterinary Regulation 2019/6.
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