European Medicines Agency

Over the past days, we’ve hosted over 100 good manufacturing practice (GMP) inspectors from Europe and around the world for a joint training on quality risk management (QRM). 15 participants represent African regulators, as part of our continuous support for the setup of the African Medicines Agency. The training aimed to familiarise GMP inspectors with the 2023 revisions to the ICH Q9(R1) guideline and related training materials. The principles and examples of tools apply to various aspects of pharmaceutical quality and help inspectors better evaluate whether and how manufacturers assess risks related to quality of medicines. Organised by EMA and the Pharmaceutical Inspections Collaboration Scheme (PIC/S), the training marks an important milestone in our efforts to strengthen regulatory systems in Africa by sharing our expertise and experience – with the joint aim of ensuring that patients, regardless of where they live, can access safe and effective medicines.

First joint report on azole fungicides is now published by 5 EU agencies under the #OneHealth umbrella! EMA examined together with European Food Safety Authority (EFSA), European Centre for Disease Prevention and Control (ECDC), European Chemicals Agency, European Environment Agency and with the support of the European Commission’s Joint Research Centre (JRC) how the extensive use of azole fungicides can increase the risk of the very common Aspergillus fungi developing resistance to essential antifungal treatments. Azole substances are widely used in plant protection products (‘pesticides’) to control fungal diseases in agriculture and horticulture, as veterinary medicines to treat fungal infections in animals, as biocides in wood preservatives, as industrial chemicals (e.g. intermediates and dyes), and in cosmetics (e.g. as anti-dandruff agents). One of the major findings of the report is that these fungi are increasingly becoming resistant to azole therapies. This makes treatment less effective. The report proposes measures to prevent and control azole resistance. The joint effort under the One Health approach is essential to protect public health by making sure that the treatments will stay effective. Read more: https://lnkd.in/ef4bJpx2

📢 The European Shortages Monitoring Platform #ESMP is now fully live!   Marketing authorisation holders and national competent authorities can now directly report information on supply, demand and availability of medicines to the platform 📅 This will become mandatory as of 2 February 2025.   Having the data available will speed up Europe’s ability to put in place coordination actions to prevent and mitigate medicine shortages.   Get prepared to use ESMP! EMA offers webinars and guidance materials to get started on the platform.   Learn more about ESMP ➡️ https://lnkd.in/dB5Xh4X2

🎉 This week marks EMA’s 30th anniversary 🎉 Over the past three decades, the healthcare environment has undergone radical scientific, technological, legislative, and social change. Through it all, EMA’s mission has been consistent: to ensure that humans and animals in the European Union have access to high-quality, safe and effective medicines when they need them. Let us take you through the key achievements and the vision that has guided the Agency over the past 30 years. Check it out 👇 https://lnkd.in/e5u4jqUK #EMA30 #PublicHealth #AnimalHealth

We’re joining a new platform! We are happy to announce that from today you can also find us on BlueSky ➡️ https://lnkd.in/dwpJcw3z We have recently decided to take a break from X, but we will continue to communicate openly with all our followers on this new channel as well as on all of our other platforms, including on here. We post about new medicines in the EU, latest health advancements, public and animal health news – follow us!

Today we hosted the Inter-Agencies Meeting on Public Health Risk Assessment hosted in Amsterdam. This important event brought together EU Health and Food Safety, as well as key EU agencies— European Food Safety Authority (EFSA), European Centre for Disease Prevention and Control (ECDC), European Chemicals Agency, European Environment Agency, European Union Drugs Agency (EUDA) and Europol - to strengthen collaboration on rapid risk assessment for public health emergencies. We had fruitful discussions on: 🔹 Aligning with Regulation 2022/2371 on serious cross-border threats to health 🔹 Enhancing rapid risk assessment methodologies 🔹 Insights from simulation exercises across Europe Together, we are advancing #publichealth resilience, preparedness and response to threats to public health in the EU!

✨ In 2024, EMA recommended 2️⃣5️⃣ #veterinary #medicines for marketing authorisation – the highest ever number of recommendations in a year. ✨ Of these, two had a new active substance, which had not previously been authorised in veterinary medicine in the EU. 💉 Among the medicines recommended for marketing authorisation in 2024, 1️⃣4️⃣ were vaccines, including seven that had been developed by means of a biotechnological process. An overview of the Agency’s key recommendations on the authorisation and safety monitoring of veterinary medicines is now available ⬇️

In 2025, EMA and the Heads of Medicines Agencies are launching a European platform for regulatory #science #research. It will bring together academia and regulators as well as other stakeholders with the aim of accelerating regulatory science research solutions. How to join? The call for expression of interest for #academia is now open. Two ways to take part in the initiative: 🔶 as nominated member of the steering group – deadline of 24 January 2025 🔶 as platform participant – submission encouraged by 24 January 2025 with the call remaining open over the course of 2025 A second call for expression of interest for patients, healthcare professionals, industry, and health technology assessment bodies to participate will open later in 2025. 📧 Submit the completed form to show your interest. Find out more here: https://lnkd.in/eN6zpKcP

📣EMA has recommended two new vaccines to protect against outbreaks of #bluetongue disease. 🐑🐄   🔵 What's bluetongue? - a disease that affects animals like sheep, goats and cattle - a viral infection that is spread by flies called Culicoides - particularly dangerous in sheep, where it is often deadly   While bluetongue does not affect humans, it can spread through farm animals causing suffering as well as economic and trade losses.   However, these new vaccines can help control disease spread, protecting livestock and supporting farmers. 🌾   🔗Read more: https://lnkd.in/djYkZYQK   #PublicHealth #Vaccines #Livestock #AnimalHealth

EMA’s safety committee, the PRAC, has started a review of medicines containing semaglutide following concerns regarding an increased risk of a non-arteritic anterior ischemic optic neuropathy (NAION), a rare eye condition, as suggested in two recent observational studies, while two other recent observational studies do not suggest an increased risk. The PRAC is now assessing whether patients treated with semaglutide may have an elevated risk of developing NAION. Read more: https://lnkd.in/em-nTwMQ