July/August 2025 – Contents
Patient voice: Shaping the future of medicine regulation
The evolving landscape of public and patient involvement
Patient involvement in the regulatory area: Insights into national level dialogues
The importance of patient advocacy in the EMA ODD process
Realising opportunities to generate RWE for regulatory decisions through randomised pragmatic trials
Diversity in clinical research: Regulatory considerations and updates
FDA comparability guidance: The impact of cell and gene therapy products
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EMA 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.
EMA 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.
NICE rejects funding for Lecanemab as treatment benefits ‘remain too small’
The National Institute for Health and Care Excellence (NICE) has recently announced that it will not back funding for the Lecanemab due to concerns about its effectiveness.
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FDA to replace animal testing with new approach methodologies
The US Food and Drug Administration (FDA) has announced plans to replace animal testing for monoclonal antibodies (MABs).
EMA 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.
RegRapPod − 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
RegRapPod − InConversation with Ivo Claassen
InConversation talks veterinary regulation with Ivo Claassen, Head of the Veterinary Medicines Division at the EMA
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