European Medicines Agency

Did you know that veterinarians and animal owners can report adverse events related to veterinary medicines? Every report is key to protecting animal and public health!  Join us in marking the first-ever Veterinary Medicines Safety Day, launched by EMA, EU Member States and the FVE - Federation of Veterinarians of Europe to raise awareness about the importance of reporting adverse events in veterinary medicine! Visit our new webpage for details 👉 https://lnkd.in/epQzY4Wq #VetMedSafety #OneHealth #AnimalHealth #Pharmacovigilance #VetMedSafetyDay

Carbapenemase-producing bacteria (CPE), once mainly a hospital concern, are now being detected in Europe’s food chain.   AMR monitoring shows an increase in the number of reported CPE cases, calling for a #OneHealth approach.   Expanding monitoring to seafood and vegetables, and tracing transmission routes, will be key to to better understanding how these bacteria spread in the food chain.   🔗 Read more: europa.eu/!gYdBGx   #EUFoodSafety #PublicHealth #AMR #Carbapenems Carlos Gonçalo Das Neves; EU Health and Food Safety

Heads up to all stakeholders involved in non-interventional studies using real-world data (RWD) to generate real-world evidence (RWE) for regulatory purposes in the EU 🌟   📣 The final reflection paper outlining key principles for conducting and assessing non-interventional studies using RWD has been published. These studies can complement data from clinical trials and fill in knowledge gaps. However, understanding the limitations and overcoming them is key to ensuring reliable evidence.   The paper covers legal obligations and regulatory requirements, study design, bias, confounding and effect modification, governance and transparency, data quality and statistical analyses. It’s part of the newly published roadmap for regulatory guidance on RWE.   Read more: https://lnkd.in/eKychq5J

📢 We have currently more than 50 traineeship opportunities open! Are you considering applying but would like to know more about the requirements?   Mark your calendars for April 14th from 10:00 to 11:00 CEST and attend the info session about the EMA traineeship programme. 📅   🔗https://lnkd.in/dCTdTynB   With traineeship placements in areas related to medicine regulation, life sciences, healthcare, information technology, pharmaceutical law, human resources, finance, communications, international affairs and more, you'll be sure to find a traineeship that fits your background and interests!

The Clinical Trials Information System #CTIS has been designated as primary registry by the World Health Organization. This designation represents a significant step forward in promoting transparency and trust in #clinicalresearch in the EU. Becoming a primary registry means that the CTIS adheres to specific criteria and ensures comprehensive research information is accessible to healthcare decision-makers globally. Read news on designation: https://lnkd.in/dZKtfGXw

We are very excited about this new collaboration with the Lancet Regional Health! It is a great opportunity to share information about the recommendations of our human medicines committee (#CHMP) and the work of EMA. Thank you to the journal and to Steffen Thirstrup, Juan Garcia Burgos for this partnership 🙏

📣 Share your thoughts on biosimilar medicine development We have just published a reflection paper setting out an approach to streamline the development and assessment of biosimilar medicines, aiming to increase patient access while maintaining strict safety standards. 🔍 What is a biosimilar? A biosimilar is a biological medicine that is highly similar to an already approved reference medicine. While not identical, biosimilars offer the same clinical effectiveness and safety as their reference products. They play a critical role in improving patient access to life-saving treatments, including for diseases like cancer, rheumatoid arthritis, and inflammatory bowel disease. 💡 Key Takeaways: - The draft proposal suggests that structural and functional comparability, along with pharmacokinetic data, may be enough to demonstrate “similarity” to the reference medicine. - This could reduce the need for extensive clinical trials, streamlining the approval process. - The approach could potentially lead to quicker patient access to essential therapies, while ensuring Europe remains a competitive market for biosimilars. ✍️ Submit your feedback on the reflection paper until 30 September 2025. 🔗 Find out more: https://lnkd.in/deQ_Q3xv

For the first time, all 27 EU countries together with Iceland and Norway have collected and reported data on both sales and use of antimicrobials in animals in their countries. The findings are presented in the first European Sales and Use of Antimicrobials for Veterinary Medicine (#ESUAvet) annual surveillance report. This work is extremely important for tackling #antimicrobialresistance. The data cover the year 2023, the starting point of a regular exercise that will result in yearly reports. Read more about this in our latest news announcement: https://lnkd.in/eerpUpB6

📢 EMA's human medicines committee, the #CHMP, recommended 5 new medicines for approval in the 🇪🇺, including: ☑️ 1 medicine to treat chronic kidney disease ☑️ 1 medicine to treat #cancer #PublicHealth Read more 👉 https://lnkd.in/ejgzw_aq

💪 A key milestone for medicines regulation in Africa! Today, the African Medicines Regulatory Harmonisation (AMRH) Initiative by AUDA NEPAD announced the successful assessment and listing of the first five medicinal products at continental level as part of a pilot to test regulatory processes and procedures. This is a major step towards the setup of the African Medicines Agency and faster access to safe and effective medicines across Africa 🌍 EMA is proud to support the journey by sharing our regulatory expertise and the European model for medicines regulation. EMA's Head of International Affairs, Martin Harvey Allchurch, spoke at the event: "Our collaboration is built on mutual respect, shared goals, and a common mission to protect and promote public health. By working together, we can strengthen regulatory systems, enhance the quality of healthcare, and address the challenges that transcend borders.” EMA’s support is possible thanks to the EU Global Gateway strategy and European Commission’s MAV+ Team Europe Initiative on Manufacturing and Access to Vaccines, Medicines and Health Technologies. 🎉 Congratulations to all partners involved in this landmark achievement! #InternationalCollaboration #AfricanMedicinesAgency #AUDA-NEPAD #AMRH #GlobalGateway #TeamEurope