All European Medicines Agency (EMA) articles
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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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Industry newsRegulators publish new guidelines for use of AI
The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) publish new guiding principles for the use of large language models (LLMs) in regulatory affairs.
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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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JournalNavigating the process complexities and challenges associated with EU-CTR transition applications
Regulatory Rapporteur May 2024 | Volume 21 | No.5 Abstract From 31 January 2025, clinical trials authorised under the old EU Clinical Trial Directive (CTD) must either have ended in the EU/EEA or have been transitioned to new EU ...
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Industry newsNovel antibiotic receives EMA’s recommendation
The European Medicines Agency has recommended marketing authorisation for an antibiotic which can treat multidrug-resistant infections.
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Industry newsCutting antibiotic usage reduces resistance levels
Cutting the use of antibiotics in both humans and animals has shown a reduction in antimicrobial-resistant bacteria.
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