European Medicines Agency

📢EMA's human medicines committee, the CHMP, recommended 12 new medicines for approval in the EU, including: ☑️ One medicine for Haemophilia A ☑️ One medicine for acne inversa ☑️ Four medicines for cancer Read more in the highlights published today 🔗 https://lnkd.in/eERW9Wx9

Did you know that some foods and drinks can affect how your medicine works? Grapefruit, coffee and bananas are just a few examples. Your package leaflet contains important information about how to take your medicine safely, including foods, drinks and alcohol you may need to be mindful of. If you’re ever unsure, ask your pharmacist or doctor. Keep safe. Read the leaflet. Learn more: https://lnkd.in/e58Cd4fE

Join us on 21 September for the joint European Commission and EMA multi-stakeholder workshop on regulatory sandboxes.   Regulatory sandboxes provide a time-limited, controlled environment where developers can design, validate and test innovative medicines or methodologies under regulatory oversight.   As the revised EU pharmaceutical legislation introduces regulatory sandboxes as a tool to support innovation, this workshop will explore: 🔹how regulatory sandboxes will be implemented under the new legislation 🔹how they can work in practice 🔹what is needed to implement and operate them effectively   📺 The workshop will be live broadcast on 21 September from 13:30 to 17:00 CEST. 👉 Watch it here: https://lnkd.in/ei5e75BN EU Health and Food Safety

What are we at EMA doing to promote women's health? Part of our mission is ensuring that the development, evaluation and use of medicines in the EU consider the needs of women, from specific conditions like endometriosis, to pregnancy and menopause. Our work covers many areas, including appropriate representation in clinical research, adequate guidance to medicine developers and improving knowledge on medicine use during pregnancy and breastfeeding, among others. In addition, we commissioned studies through DARWIN EU® to generate real-world evidence to improve understanding of women's health and where information from clinical trials is too limited. Areas of research include: 📌Differences between women and men in disease patterns, treatment and health outcomes 📌Women's health conditions, such as endometriosis and polyendocrine metabolic ovarian syndrome 📌Medicine use and outcomes in pregnancy and breastfeeding. Find out about our work in women's health from EMA’s new webpage: https://lnkd.in/eQ-r6UWg If you want to learn more, follow our workshop on women’s health, broadcast live on 28 and 29 September 2026, to hear different perspectives from patients, healthcare professionals, academia, industry, and global partners (link in comments).

At its September meeting, EMA’s safety committee #PRAC started a review of injectable iron-containing medicines following concerns about the risk of low phosphate levels in the blood and related bone problems. The review will assess whether existing measures to minimise these risks are effective and whether any changes to the medicines’ authorisations are needed. Injectable iron-containing medicines are used to treat iron deficiencies when oral iron treatments are not suitable or when iron levels need to be restored quickly. Read more in the highlights: https://lnkd.in/emAJBSFW

Good news! A new EU supply chain has been put in place to end the shortage of Visudyne, a medicine used to treat adults with certain serious eye conditions. This clears the path to fully restore supply levels across the EU in 2027. Until supply is fully restored, the EU medicines regulatory network will continue coordinating the fair allocation of available stocks so that Visudyne reaches those who need it most. This is the result of close collaboration between EU regulators, the European Commission, Member States and industry to manage the crisis and put an end to critical shortages of this medicine. More information: https://lnkd.in/ehukxC-n

"Being a trainee at the agency allows you to look at EMA as a whole." In this episode of Inside EMA, current trainees share how the programme offers much more than professional experience. They describe joining a community of more than 50 peers, exploring different areas of the Agency, learning from experts and gaining insight into the European medicines regulatory network. Listen to their stories and advice for future applicants. We're currently recruiting trainees across a range of exciting areas, see the list of available positions and requirements here: https://lnkd.in/dF-W7ac 🎧 Available on all major podcast platforms.

How can Europe remain competitive, innovative and resilient while delivering better health outcomes for its citizens?   This was the main topic of discussion as EMA welcomed the Ambassador of Embassy of Ireland in the Netherlands, H.E. Ann Derwin, during Ireland's Presidency of the Council of the European Union.   From the future of medicines to AI, innovation, supply chain resilience and health security, the Irish Presidency's priorities closely align with EMA's work to support public health across Europe and help to ensure that Europe remains a globally competitive location for life sciences, research and pharmaceutical innovation:   🔹 Advancing Europe's medicines framework through the implementation of the new EU pharmaceutical legislation and the progress on the Critical Medicines Act. 🔹 Supporting data-driven innovation through initiatives such as the European Health Data Space and the Biotech Act, enabling the secure and responsible use of health data for research, innovation and regulatory decision-making. 🔹 Strengthening Europe's health security and resilience by addressing medicine shortages, reinforcing supply chains and enhancing preparedness for future health threats. 🔹 Promoting a competitive and thriving life sciences ecosystem that supports research, innovation and the development of new therapies for patients across Europe, while strengthening Europe's position as a global leader in medicines development and regulation.   As the Ambassador noted, the Irish proverb Ní neart go cur le chéile ("there is no strength without unity") captures the spirit behind both the Irish Presidency and EMA's European regulatory network: achieving more through cooperation, scientific excellence and shared purpose.   Thank you for the insightful exchange and continued partnership in advancing public health for people across the EU.

🚀 EMA launches a new voluntary data submission pilot to advance innovative alternatives to animal testing. Developers can submit data generated using new approach methodologies and receive tailored scientific feedback from EMA, in a non-binding setting. These innovative methods have the potential to generate information that matches or even exceeds what traditional approaches can provide while helping to reduce and replace animal studies in the non-clinical development of medicines. The pilot is part of EMA’s efforts to foster the regulatory acceptance of new approach methodologies by enabling regulators to gain experience with these approaches and assess their scientific value in a regulatory context. Learn more about the pilot and its contribution to medicine regulation 👉 https://lnkd.in/eKHvThUb

Do you know that global regulators are running a pilot that allows them to review a company submission simultaneously when important manufacturing changes need to be made after a medicine was approved? A recent example is reducing or removing the need for animal-derived materials to better align with the 3Rs principles: replacement, reduction and refinement of animal use. 👇 Read more in the latest guest article authored by Evdokia Korakianiti, our Head of Quality and Safety Department.