All European Medicines Agency (EMA) articles
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Industry news
Regulators 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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Journal
A 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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Journal
Navigating 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 news
Novel 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 news
Cutting 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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Journal
Clinical trial design – keeping up with innovation
Regulatory Rapporteur March 2024 | Volume 21 | No.3 Abstract A well-designed clinical trial is essential for the collection of reliable, robust and meaningful data to ensure the protection of participants rights and safety and also minimise economic losses ...
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Industry news
EMA platform to monitor use of antimicrobials
All EU member states are required to submit data on sales and use of antimicrobials in animals to the EMA’s new platform.
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Industry news
EMA set to host psychedelics uses workshop in April
The EMA will host a workshop to discuss the therapeutic potential of psychedelic substances to address unmet medical need.
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Journal
Artificial intelligence in drug discovery
Regulatory Rapporteur January 2024 | Volume 21 | No.1 Introduction The recent publication of papers by the European Medicines Agency (EMA)[1] and the Food and Drug Administration (FDA)[2][3] has spurred the debate on ...
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Industry news
EMA/HMA publish workplan for the responsible use of AI
The EMA and the HMA have published a multi-annual AI workplan 2023-2028 to facilitate the safe and effective use of artificial intelligence.
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Video
ICMRA regulators to mark its 10th year at event in Australia
International Coalition of Medicines Regulatory Authorities set to celebrate 10 years of strategic leadership at Melbourne summit.
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Industry news
Patients warned about falsified Ozempic medication
The EMA has warned patients and healthcare professionals across the EU about pre-filled injection pens falsely labelled as Ozempic.
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Journal
Transition to the new QRD template for veterinary medicines: challenges and opportunities
The product information template version 9 (QRD v.9) supports the requirements of the Veterinary Medicinal Products Regulation (EU) 2019/6[1] (VMR), which has applied since 28 January 2022. Considering the high workload and costs associated with the quality review document (QRD) updates, the huge number of veterinary medicinal products (VMPs) concerned, ...
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Industry news
EMA proposes novel method to assess CKD therapy efficacy
Glomerular filtration rate slope can be used as a surragate end point to assess clinical benefit for treatments in CKD in some trial settings.
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Industry news
EMA future ‘VetMeds’ for healthy animals and humans; seminar
In the lead up to the EMA’s Veterinary Awareness Day, Ivo Classen sits down to discuss the agency’s progress in the field of veterinary medicines.
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Industry news
Safe use of AI is subject of EMA reflection paper
The EMA has published a draft paper on how artificial intelligence can support the development and use of human and veterinary medicines.
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Journal
A critical review and comparison of the processes when seeking Scientific Advice in the EU and the USA – Part 2
GRAY, MSc − PART TWO OF A TWO-PART SERIES(See part 1 here) Scientific Advice (SA) is provided by all major regulatory agencies to pharmaceutical companies and other interested parties who are developing new medicines. Regulatory agencies such as EMA and FDA regard provision of SA as a ...
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Industry news
Good safety profile of COVID-19 vaccines declared by ICMRA
COVID-19 vaccines show a very good safety profile in all age groups, including people with underlying medical conditions and pregnancy.