European Medicines Agency

📢EMA's human medicines committee, the #CHMP, recommended 2 new medicines for approval in the 🇪🇺: ☑️ The first treatment for non-cystic fibrosis #bronchiectasis ☑️ 1 medicine to treat persistent or chronic immune #thrombocytopenia   Read more in the highlights published today 👉 https://lnkd.in/dfkdNBSe Learn about the first treatment for non-cystic fibrosis here 👉 https://lnkd.in/esYXM-3N #PublicHealth

As part of #BreastCancerAwarenessMonth, we are proud of our colleagues who joined the Pink Bootcamp Run/Walk today 💗 From walkers to runners, everyone showed great energy and spirit during the 3km walk and 5km run, with bootcamp stops, music, and plenty of smiles along the way! This event is also a reminder that staying active (whether walking, running, or moving in any form) supports overall wellbeing and helps reduce the risk of breast cancer. A huge thank you to everyone who wore pink or white and donated in support of Stichting Pink Ribbon. We’re happy to share that we’ve already raised over €3,000...and October isn't over yet! 

🚀 The 1st EMA/HMA multi-Stakeholder forum on EudraVigilance and signal detection is just around the corner, taking place on 5 November. This key event will bring together stakeholders across the regulatory and pharmaceutical landscape to discuss the latest developments in adverse drug reaction case processing, signal management, and international guidance. 💡 EudraVigilance is the EU’s central database for managing and analysing reports of suspected adverse reactions, a cornerstone of ensuring the safe and effective use of medicines. What to look forward to at the forum: ✔️ Best practices for signal assessment ✔️ Updates on pharmacovigilance inspections ✔️ The use of AI in pharmacovigilance. This is a unique opportunity to connect, collaborate, and contribute to the future of medicines safety. 🗓️ Register by 25 October to secure your virtual seat! 👉 https://lnkd.in/esYG9i6C

🎉 Celebrating 20 Years of Supporting Innovation: EMA Small Medium-sized Enterprises (SME) Regulation Roundtable 📣 Join us on 17 October 2025 for a special roundtable hosted by EMA to mark the 20th anniversary of the SME Regulation. Since 2005, the SME Regulation has helped small and medium-sized enterprises bring innovative medicines to market by offering financial and administrative support through EMA’s SME Office. This event will bring together: 🟦 EU policymakers, including representatives from the European Commission and European Medicines Regulatory Network 🟦 Public and private investors 🟦 Life science incubators 🟦 Industry organisations Together, we’ll reflect on the achievements of the SME Regulation and explore future opportunities to support SMEs and innovation in the pharmaceutical and MedTech sectors. 📺 Watch the event live: https://lnkd.in/d4n4VHga

💡 Collaboration in action: European Association of Urology Guidelines on Urological Infections & European Medicines Agency EMA! Our latest article in European Urology highlights the need for responsible #fluoroquinolone prescribing ⚕️💊. Despite the European Medicines Agency’s (EMA 🏛️) risk minimisation measures (RMMs) introduced in 2019, implementation in clinical practice remains challenging ⚠️. This underscores the importance of close teamwork 🤝 between regulatory authorities and clinical societies. As urologists and members of the EAU Guidelines Panel on Urological Infections 📋, we play a key role in translating guidelines into practice 🔬 and safeguarding patients 🛡️. 👉 Read the full article here: https://lnkd.in/e9PukUne A big thank you to Juan Garcia Burgos, Eva Jirsova, Jennifer Kranz, and the entire EMA team 🙏 for making this collaboration possible! #Urology #PatientSafety #EAUGuidelines #EMA #AMR #AntimicrobialStewardship #Fluoroquinolone

🌍 Strengthening Regulatory Capacity in Candidate Countries On 2–3 October, EMA held a face-to-face training in Podgorica, Montenegro, under the Instrument for Pre-Accession Assistance (IPA) III programme. This marks the first time the annual assessors training was hosted in a candidate country - a milestone made possible thanks to the warm hospitality of CInMED Montenegro - the Institute for Medicines and Medical Devices of Montenegro. 🧪 The training focused on hands-on dossier evaluation, simulating real assessments of our human medicines committee. Assessors from national competent authorities from Albania, Bosnia and Herzegovina, Kosovo, Montenegro, North Macedonia, Serbia and Ukraine took part in the two-day event. Thank you to our trainers: Caroline Voltz-Girolt (EMA), Harald Enzmann (Bundesinstitut für Arzneimittel und Medizinprodukte) and Daniela Philadelphy (Austrian Agency for Health and Food Safety). 📍 Looking forward to continuing this journey of shared learning and regulatory excellence.

Just published! EMA's October 2025 Management Board highlights are now available. The Board noted EMA's mid-year report and endorsed the first data strategy for the European medicines regulatory network. It was also updated on the activities of the International Coalition of Medicines Regulatory Authorities, which has been chaired by EMA since 2019.  The next chair of the coalition will be elected during the upcoming ICMRA summit to be held in Amsterdam from 21-24 October.   For the full highlights 👉 https://lnkd.in/ezPFcNwB

Our safety committee, the #PRAC, has just concluded its October meeting. PRAC responsibilities cover all aspects of the risk management of the use of medicines: assessment of safety signals, risk management plans, periodic safety update reports and post-authorisation safety studies. Information on all topics discussed by the PRAC is available in the agenda. Read more: https://lnkd.in/dPyiUU8G

The European Environment Agency has released its State of the Environment 2025 assessment, providing a comprehensive look at Europe's environmental challenges. The findings underscore a critical #OneHealth message: environmental sustainability is a cornerstone of public and animal health.   Issues like chemical pollution, antimicrobial resistance, and biodiversity loss have direct implications for the efficacy and safety of medicines, the emergence of diseases, and overall population health.    Read more about the systematic changes proposed by the EEA 👇 https://lnkd.in/eQhyabe6 #EuropesEnvironment2025

📢 Reflection paper on Patient Experience Data – make your views heard! We’ve just published the first reflection paper on Patient Experience Data (PED), with the aim of opening a new chapter in how patient perspectives and needs are considered in the regulation of medicines across the EU. Data that come directly from patients reflect what truly matters to them, from treatment outcomes to quality of life – without clinician interpretation. For this reason, the reflection paper lays out core principles on collecting, analysing, and integrating PED across the medicine lifecycle – from development and authorisation to post-market monitoring. It also highlights the role of emerging sources of data such as #mobilehealth and #socialmedia. Are you a medicine developer, patient group, researcher, regulator, or other stakeholder? We want to hear from you. 💬 Deadline for feedback: 31 January 2026 📥 Have your say in shaping how patient voices are embedded in regulatory science. This is your chance to help redefine what meaningful outcomes look like in healthcare. 📄 Read the paper: https://lnkd.in/dxpe4rj8