European Medicines Agency’s Post

📣 We have compiled a collection of websites and documents that will answer many of your questions and concerns regarding vaccines and immunisations. Be sure to always consult independent and factual sources of information before making vaccination decisions. It will be a worthwhile investment of your time. Consult the document below and share it with those you think will find it useful! #UnitedinProtection #EIW2024 #vaccineswork

📢EMA's human medicines committee, the #CHMP, recommended 8 new medicines for approval in the 🇪🇺: ☑️ 3 medicines to treat #cancer ☑️ 1 medicine against a rare bleeding disorder #HaemophiliaA ☑️ 1 treatment for adults with #OverActiveBladder Syndrome ☑️ 1 medicine to treat #ResistantHypertension #PublicHealth https://europa.eu/!XgGxKB

📢 EMA's veterinary medicines committee, the CVMP, recommended a new vaccine that is effective against the currently circulating strains of highly pathogenic avian influenza (bird flu). 💉 🐥 This vaccine is for the active immunisation of one-day-old chicks or 18–19 day-old embryonated chicken eggs to reduce mortality, clinical signs and virus excretion due to infection with highly pathogenic Avian Influenza (HPAI) virus of the H5 type. https://lnkd.in/enNvaWgq

📣 EMA’s report on stakeholder engagement activities for 2022-2023 is out now 👉 https://lnkd.in/dt8HMnES We asked Juan Garcia Burgos how he thinks working with stakeholders has changed in the last years, especially since the pandemic. His take-home messages? The key factors are: 📌 early dialogue and collaboration 📌 balancing a multi-stakeholder approach with targeted engagement 📌 working together to build trust Read the full article here ⬇

🌟 Save the date for an insightful LinkedIn live discussion on the therapeutic potential of psychedelics in mental health 🧠 Our Chief Medical Officer, Steffen Thirstrup, will be live on Linkedin with Alessandro Faia, Press Officer, to delve into this crucial topic. 📅 When? 7 May 2024, from 11h30 CEST. 📣Join the conversation and send in your questions! You can also share your questions in advance in the comment section of this post! This Linkedin Live session is a continuation of our multi-stakeholder workshop that took place on 16-17 April (link in comments), where patients, healthcare professionals, academia, regulators, and industry engaged in a constructive dialogue about the development of safe and effective psychedelic medicines. These are the three key themes that emerged during the workshop: 📌 Developers need to get in touch with regulators as early as possible to ensure their development plans align with existing regulatory frameworks; 📌 We must prioritise reliable and valid evidence to address uncertainties in psychedelic research such as optimal dosing and the requirements for “set and setting”; 📌 Collaboration between regulators, researchers, patients, policymakers, healthcare professionals and industry is crucial to advance innovative treatments for mental health conditions. #MentalHealth #Psychedelics #Innovation #EMAInsights #RegulatoryChallenges 

📣 Our Medicines Shortages Steering Group (MSSG) has released recommendations to address vulnerabilities in supply chains of critical medicines, ensuring that EU healthcare system function properly. These measures, developed in collaboration with stakeholders, aim to: 👉 Increase manufacturing capacity and diversify suppliers 🔍  👉 Monitor available stocks, supply and demand 💊  👉 Provide scientific and regulatory support, including to SMEs 🤝 Read more about these initiatives and MSSG's pivotal role in crisis management here 👉 https://lnkd.in/dyiNVvKr #medicines #health #healthcare #shortages #publichealth 

#UnitedInProtection #EIW2024

📢 Just published: ICMRA/WHO report on strain updates for COVID-19 vaccines   The report provides an overview of regulatory considerations for updating COVID-19 vaccine composition, such as timings and data requirements for marketing authorisation. Like many viruses, SARS-CoV-2 continuously changes, meaning that vaccines need to be adapted to ensure they keep protecting us.   This document is the outcome of a workshop organised by the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) that brought together representatives of national regulatory authorities, WHO, scientists, and industry to present their perspectives and experience with the strain updates and to discuss the way forward.   🔗 https://lnkd.in/e5fnFRjD

📢 We have currently more than 40 traineeship opportunities open! Are you considering applying but would like to know more about the requirements?   Mark your calendars for April 23rd from 10:00 to 11:00 CET and attend the info session about the EMA traineeship programme. 📅 🔗 https://lnkd.in/eb4b_5mJ 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 will be sure to find a traineeship that fits your background and interests!

📣 Available evidence does not support the link between GLP-1 receptor agonists and suicidal and self-injurious thoughts and actions. GLP-1 receptor agonists are used to treat type 2 diabetes and some are also authorised for weight management under certain conditions in adults who are obese or overweight.   This is one of the key conclusions of our safety committee, the PRAC, after its April meeting.   Read more in the link below. https://lnkd.in/egg2Ngc3 #pharmacovigilance