European Medicines Agency

EMA and African regulators are strengthening collaboration in response to the Ebola outbreak caused by the Bundibugyo virus in the DRC and Uganda. For the first time, EMA’s Emergency Task Force is engaging with the African Medicines Agency and its national regulatory agencies, leveraging expertise from the AVAREF to discuss clinical trial designs and advance potential vaccines, treatments and post‑exposure prophylaxis options. With no authorised medical countermeasures for Bundibugyo virus disease, rapid, coordinated and scientifically rigorous regulatory action is essential. Together, experts are reviewing promising candidates — including recombinant and mRNA vaccines, monoclonal antibodies and antivirals — to accelerate development pathways and support an effective public‑health response. Strengthening global regulatory cooperation is key to tackling emerging health threats. Find out more: https://lnkd.in/evGSnJTF

BfArM and EMA: Data, AI and medicines regulation in Europe How are AI and big data shaping the future of medicines regulation? Prof. Dr. Karl Christian Broich (BfArM) and Dr. Peter Arlett (EMA) discuss the impact of AI, real-world data, and the European Health Data Space on regulatory science and what it means for public health. 🎥 Watch the video to hear their insights.

Clinical trials are a vital part of developing safe and effective medicines. Watch our new video to learn how clinical trials work in the EU, and how patients contribute to advancing medical research. Whether you're curious about how medicines are developed or about what it takes to run a clinical trial in the EU, this video gives you a clear and accessible overview of the process. Learn more: https://lnkd.in/dj-DQXPF Begonya Nafría Escalera Joel Passarinho Helle Christiansen Denis Lacombe

EMA welcomes the European Commission’s roadmap to phase out animal testing for chemical safety assessments and fully supports its direction. We will continue promoting the 3Rs principles, replacing, reducing and refining the use of animals, and encouraging the responsible use of new approach methodologies, such as advanced in‑vitro and computational tools, in medicines development and regulation. We also look forward to working even more closely with partners like European Food Safety Authority (EFSA) and European Chemicals Agency through the new collaboration structures proposed in the roadmap, helping drive progress across sectors while also protecting human and animal health.

June marks the start of PRIDE month - and we have a big announcement…   EMA will be part of the 2026 celebrations of World Pride in Amsterdam. Look out for us in the Canal Parade on 1 August!   Under the banner “United for Health”, we are taking part to highlight our commitment to diversity, inclusion and public health for the 450 million people we serve across the EU.   We are also proud to be joined by representatives from EURORDIS-Rare Diseases Europe, European AIDS Treatment Group, and the European Patients' Forum, reflecting our belief that health and scientific excellence grow stronger when all voices are represented and respected. Over the next two months, we will share updates of our preparations and reflections on inclusive science. Follow us on LinkedIn, YouTube, Bluesky, and Instagram (@onehealth_eu). Inclusive science improves lives - for everyone. Read more here 👉 https://lnkd.in/eWs8v7sP   #Pride2026 #WorldPride #loveisthebestmedicine  

Medicine regulation is significantly transformed by the exponential growth in healthcare and regulatory data. Such progress brings opportunities but also challenges. This latest scientific article in Nature Reviews Drug Discovery, authored by Francois Domergue, Peter Arlett, Emer Cooke and Karl Christian Broich, presents how the EU medicines regulatory system is transitioning to a more data-driven ecosystem that can improve decision making and accelerate medicines development to the benefit of patients. Read more: https://lnkd.in/e3T8nu4z *This article is available for open access until 5 June 2026. 

🎙️ New Inside EMA episode: data, trust and the future of medicines Medicine regulation is increasingly data-driven. In this episode of Inside EMA, we explore how real-world healthcare data from across Europe helps answer key questions on the safety and effectiveness of medicines. Tune in to hear from Peter Arlett, Head of the Data Analytics and Methods Task Force, and Denise Umuhire, Real-World Evidence Specialist, as they discuss how using diverse data sources helps strengthen trust in medicine regulation. 🎧 Watch or listen now: https://lnkd.in/eHW_9Mfe

Interested in helping the EU deliver real-world evidence on medicines? Don't miss EMA's procurement procedure for the coordination centre of our Data Analysis and Real-World Interrogation Network project – simply known as DARWIN EU®. This is a network set up to deliver timely and reliable evidence on the use, safety and effectiveness of medicines for human use. It aims to help patients and support regulatory decision-making. The DARWIN EU Coordination Centre will contribute to: ✅ maintaining and further enlarging DARWIN EU's network of data partners ✅ carrying out non-interventional studies with these partners The deadline to submit your request to participate in this procurement procedure is 15 June 2026, 16:00 Amsterdam time (CEST). Find more information, including how to participate in this procurement procedure, on our website: https://lnkd.in/enrhykWr

EMA has recommended the first oral GLP-1 treatment for weight management, offering an alternative to weekly injections. This treatment can be used, together with diet and physical activity, in adults with obesity, or who are overweight and have at least one weight-related condition. It will only be available with a prescription.   Read more 👉 https://lnkd.in/ewqkQFPa

📢Our human medicines committee, the CHMP, recommended 8 new medicines for approval in the EU, including the first medicine to treat rare uncontrolled growth of body tissues and a medicine for two types of pulmonary fibrosis. The CHMP also recommended an extension to the marketing authorisation of the first glucagon-like peptide (GLP-1) receptor agonist for weight management developed for oral use. Read more in the highlights published today 🔗https://lnkd.in/eGCZGPfT