European Medicines Agency

Towards better, faster clinical trials in Europe! 🔴 💻 Join the LinkedIn live discussion on #ACTEU, the Accelerating Clinical Trials in the EU initiative, with 🎙 Peter Arlett, Head of Data Analytics and Methods Task Force, 🎙 Marianne Lunzer, chair of the of the Heads of Medicines Agencies (HMA) Clinical Trials Coordination Group (CTCG) and member of the Austrian Agency for Health and Food Safety. Hear more about ACT EU's priority actions and how the initiative aims to strengthen clinical research in Europe. When? 🗓️ Tuesday 16 July at 12:00 CEST We invite you to post the questions for our two speakers via the comment section, either in advance or during the LinkedIn event. #ACTEU #HealthUnion #clinicaltrials

📢 Call for expression of interest 📢 Are you a manufacturer or medicine developer? Are you an academic working in manufacturing innovation? EMA is calling for case studies on platform technologies for its 4th Listen-and-Learn Focus Group meeting on quality and manufacturing innovation on 19-20 November 2024. ➡️✍️ Submit your case study by 31 July 2024 for a chance to discuss it at the meeting. Key points for discussion will be: 📌 Platforms for medicinal products manufactured using prior knowledge 📌 Platforms for medicinal products against serious health threats like pandemics 📌 Platforms for manufacturing personalised or individualised medicines 🔗 Find out more - https://lnkd.in/djQC9nxj #MedicinesInnovation #QualityInnovation #PlatformTechnologies 

🔎 💊 Our safety committee, the #PRAC, at its July meeting has recommended new measures to minimise the risk of aspiration with GLP-1 medicines during anaesthesia and deep sedation. Patients treated with GLP-1 medicines should inform the doctor involved if they have a planned surgery.   The PRAC also agreed a direct healthcare professional communication (DHPC) for glatiramer acetate, a medicine authorised for the treatment of relapsing forms of multiple sclerosis. Following an EU-wide review of all available data, the PRAC concluded that the medicine is associated with anaphylactic reactions which may occur even after months up to years after initiation of treatment. Cases with a fatal outcome have been reported. The DHPC will inform healthcare professionals about this risk and recommend that patients and/or caregivers be advised of the signs and symptoms and to seek emergency care in the event of an anaphylactic reaction.   Read more: https://lnkd.in/eKPBbPFf

📣 EMA’s safety Committee, the #PRAC, just elected Ulla Wändel Liminga from the Swedish Medical Products Agency (Medical Products Agency Läkemedelsverket) as its new Chair for a three-year mandate starting in September 2024. Congratulations! 👏 She will take over from Sabine Straus, a member of the Dutch national competent authority, the Medicines Evaluation Board (College ter Beoordeling van Geneesmiddelen), who has chaired the PRAC for 6 years, including during the COVID-19 pandemic. A huge thank you to Dr Straus for her relentless commitment to public health and exemplary leadership in incredibly difficult times. 🙌 Read more in the news announcement: https://lnkd.in/gv5KR9rn

A key part of our job as medicines regulators is to focus on public health in our own country and region. Increasingly though, health and medicine regulation is a cross-border concern and, therefore, we need to think and act not only locally, but also globally. Regardless of whether you are a big or small regulator, we know that collaboration and reliance are more important than ever. They also help support regulatory harmonisation, capacity building, transparency and trust. EMA collaborates with medicine regulators outside the EU in the scientific evaluation of certain medicines under a framework called ‘Opening Procedures at EMA to Non-EU Authorities’ (#OPEN). With OPEN, several regulators can evaluate a medicine in parallel with EMA, remaining scientifically and procedurally independent from one another while sharing information, expertise, and approaches during the evaluation process. This sort of collaborative approach requires alignment of dossiers and submissions to improve regulatory convergence. Importantly, it can also result in earlier access and potentially faster global approvals through leveraging existing or ongoing assessments and expertise beyond the EU regulatory network, leading to fewer questions for industry and labelling differences. The recent EMA green-light assessment of a #Chikungunya vaccine working together with both WHO and the Brazilian regulator ANVISA is the latest example. Applicants can ask for review under OPEN for products covered by the scope of the pathway: #AMR, #PRIME, high unmet medical needs and medicines responding to health threats or public health emergencies. Begun in December 2020 to increase international collaboration and share scientific expertise on the evaluation of #COVID19 vaccines and therapeutics, the OPEN pathway allows non-EU regulators to conduct near-concurrent reviews of certain new medicines and exchange their views and reports on the assessment of the medicine. Experts from our OPEN partners participate in the Agency’s assessment in the same way as our committee members, except for the final decision making, when each regulatory authority maintains its independence.  Our partners are:  🌏 Australia: Therapeutic Goods Administration (TGA)  🌎 Brazil: Brazilian Health Regulatory Agency (ANVISA)  🌎 Canada: Health Canada | Santé Canada (HC)  🌏 Japan: Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA)  🌏 Republic of Korea: Ministry of Food and Drug Safety of Republic of Korea (MFDS)  🌍 Switzerland: Swiss Agency for Therapeutic Product (Swissmedic)  🌐 World Health Organization (WHO)    This is an exciting pathway that has already shown impact. EMA recently changed the process in response to industry requests to be able to apply for their product to go into OPEN, and full details of the revisions can be found in our updated Q&A document: https://europa.eu/!RNbnQh [A guest post by Martin Harvey Allchurch]

🎉 We're excited to announce new appointments in the Legal Department and the Regulatory Science and Innovation Task Force at EMA! 🔹 Georgia Gavriilidou has joined EMA as the new Head of the Legal Department, effective 1 July 2024. She succeeds Stefano Marino following his retirement. 🔹 Emmanuel Cormier has taken over as Head of the Regulatory Science and Innovation Task Force, succeeding Anthony Humphreys who retired in January 2024. Please join us in welcoming Georgia and Emmanuel to their new roles! 👏 #EMA #Leadership #Innovation #RegulatoryScience #Legal

📢EMA's human medicines committee, the #CHMP, recommended 10 new medicines for approval in the 🇪🇺: ☑️ The 1st emergency treatment against allergic reactions administered as nasal spray ☑️ 1 #mRNA #vaccine for respiratory syncytial virus #RSV ☑️ 1 medicine to treat a pulmonary #RareDisease #PublicHealth ➡ https://lnkd.in/dMD7puTw

We have just published recommendation to help tackle shortages of #GLP1 receptor agonists across the EU 💊🤲 looking out for the patients who need them most. ▶ https://lnkd.in/eW9yvkrN

Watch live 🔴 We are now starting our press briefing on shortages of GLP-1 receptor agonists. Don’t miss our tweets 🧵 during the press briefing. Follow #EMAPresser

Follow EMA’s press briefing on GLP-1 receptor agonists shortages tomorrow. 📅 26/06/2024 at 15:30 CET 💻 🔴 live on EMA’s official LinkedIn page 🗣 with Emer Cooke (EMA Executive Director) and Karl Broich (President of Bundesinstitut für Arzneimittel und Medizinprodukte) Learn about the joint EU actions to tackle the shortages of these medicines approved to treat diabetes and manage weight loss in people with obesity and weight-related conditions.   Please note that we will take live questions only from accredited journalists who registered in advance to our Webex event. To register ▶ https://lnkd.in/gnTQZGtZ   #EMAPresser #shortages #GLP1