All European Medicines Agency (EMA) articles
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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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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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ContentsJuly/August 2025 – Contents
The July/August issue of Regulatory Rapporteur focuses on patient involvement.
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EditorialPatient voice: Shaping the future of medicine regulation
This issue looks at the evolving landscape of public and patient involvement (PPI) and how the views of the patient community are being included in research, academia, health and social care and regulatory decision-making.
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PodcastsRegRapPod − InConversation with Hugues Malonne
InConversation talks about the role of the Federal Agency for Medicines and Health Products (FAMHP) with Hugues Malonne, Chief Executive Officer at FAMHP
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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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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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ContentsJune 2025 – Contents
The June issue of Regulatory Rapporteur focuses on veterinary medicines.
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EditorialVeterinary medicines: Translating regulation into practice
This issue looks at the impact of the Veterinary Regulation 2019/6, the effect of the new EMA fees on marketing authorisation holders, and the regulatory challenges associated with the practical use of bacteriophages in veterinary medicine.
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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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JournalNavigating orphan drug designation in the EU
Orphan drug designation (ODD) is granted to help with the development of treatement for rare diseases. In this article, ODD’s legal framework and its benefits and challenges are explored.
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Industry newsKey milestone reached in African medicines regulation
A key milestone for medicines regulation in Africa has been reached with the first continental listing of five medicinal products by the African Medicines Regulatory Harmonisation (AMRH) Steering Committee.
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PodcastsRegRapPod − InConversation with Ivo Claassen
InConversation talks veterinary regulation with Ivo Claassen, Head of the Veterinary Medicines Division at the EMA
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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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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 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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JournalConsiderations for generics developers moving into the field of biosimilars
Many generic developers have experience in both manufacturing and gaining US and EU approval for generics which are small molecule alternatives to the authorised original products. These developers possess the relevant skillsets to allow them to pursue the development of biosimilars, which are large molecule biologics highly similar to the authorised original products.
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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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