European Medicines Agency

Celebrating the achievements of the Big Data Steering Group (BDSG) by the Heads of Medicines Agencies (HMA) and EMA 🎉   Co-chaired by the Lægemiddelstyrelsen (Danish Medicines Agency) and EMA, the BDSG held its final meeting on 11 December, marking a five-year journey towards more data-driven medicines regulation.   From creating a European real-world data network of 140 million patients to building an expert workforce, the BDSG has demonstrated the value of large datasets in medicines regulation and delivered benefits to Europeans in 11 data-related areas, including data quality, discoverability and training.   Starting January 2025, we're excited to continue this journey with the new Network Data Steering Group (NDSG). Guided by our shared European strategy, we'll accelerate efforts to deliver better medicines to patients and optimise their use through enhanced data interoperability, exchange and use across the EU. #digitalhealth #healthdata #EU In the picture: Nils Falk Bjerregaard and Peter Arlett

A common EU approach to data transparency in medicine regulation 💊 EMA and HMA have updated their principles for identifying and disclosing commercially confidential information and personal data in marketing authorisation applications for human medicines. This ensures extensive transparency when disclosing information to the public once a medicine is authorised, both in response to access-to-documents requests and in the proactive publication of data. The update aligns the guidance with the progress made by regulators in their transparency journey since it was initially released in 2012. The revised guidance also sets out how personal data will be protected if it can lead to the identification of a person. Find out more 🔗 https://europa.eu/!tMrtgD

Is Europe ready for electronic product information (ePI)? A report published today outlines what the next steps are towards implementation of ePI for medicines in the EU and the recommendations on how to get there. While some more development is still needed, including on additional functionalities and more integration with current IT systems, ePI is on its way. Its implementation will begin in phases, starting on a voluntary basis, from products authorised at EU level, progressively expanding to member states. Through product information in an electronic format, patients and prescribers will interact with their medicines in a whole different way, with quick and easy digital access to vital, up-to-date information, when and where they need it. Find out more here: https://lnkd.in/eRip8mT6 #digitalhealth #europeanunion

Just published! EMA’s December 2024 Management Board meeting highlights are now available. At its December meeting, the Board adopted EMA’s work programme and budget for 2025, and was updated on the Agency’s work on shortages. In 2025, the Agency will maintain its focus on: ✅ accelerating and optimising the assessment of key medicines, ✅ improving both accessibility and availability of medicines, ✅ working on the approach to future-proofing medicines regulation in the EU in preparation for the new pharmaceutical legislation. Link to the full text in the comment section. #pharmaceutical #UE #medicines

📢EMA's human medicines committee, the #CHMP, recommended 17 new medicines for approval in the EU: ☑️ 1st medicine to treat #vonHippelLindau disease ☑️ 1st treatment for for #PeripheralThyrotoxicosis in patients with Allan-Herndon-Dudley syndrome ☑️ 2 medicines to treat #cancer Read more in the latest CHMP highlights: #PublicHealth

What regulatory and scientific considerations do we make when evaluating updated #COVID vaccines? As COVID-19 continues to evolve, the EU has adapted its regulatory framework to keep pace with emerging variants using an approach based on seasonal flu vaccines. A new article by EMA experts explores the requirements for chemistry, manufacturing and quality control data for the approval of these vaccines. Find out more : https://lnkd.in/d4ya3Fb2

EMA invites all professionals involved in marketing authorisation applications for new medicines to a Q&A session. Join Francesca Day (nee Mazzei), EMA’s Head of Therapeutic Areas, and Alessandro Faia, EMA press officer, as they delve into a critical topic: “The Predictability of Marketing Authorisation Application Submissions.” 🗓 Date: Thurs, 5 December 2024  ⏰ Time: 12:30 to 13:15 Amsterdam time (CET)    💡 Did you know? In 2023, only 35% of marketing authorisation applications were submitted on their agreed dates. These delays impact long-term planning and approval timelines for much-needed medicines across the EU. This session will:  ✔ Outline the impact of these delays on EMA and the European network   ✔ Discuss the challenges companies face in meeting submission deadlines  ✔ Highlight EMA’s initiatives to improve efficiency in assessment and approval processes ✔ Share tools and recommendations to help companies better plan their submissions 📣 Join us live on LinkedIn! Ask your questions during the session via the comment section. You can also share your questions in advance in the comment section of this post.

We have opened a public consultation on applying the Data Quality Framework for EU medicines regulation to real-world data. The chapter under consultation provides guidance to assess the quality of real-world data in medicine assessments. The aim is to enhance use of real-world evidence in regulatory decisions. Regulators, pharmaceutical companies, academia and other interested stakeholders, have your say and share your insights with us! 📌 Deadline for comments: 31 January 2025 🔗 Find out more: https://lnkd.in/dSpx3kqv #RealWorldData #DataQuality #PublicConsultation 

Our safety committee, the #PRAC, at its December meeting, concluded that: ✅ the currently available evidence is not sufficient to establish a causal relationship between the use of the antibiotic doxycycline and the risk of suicidality. ✅ measures are needed to minimise the risk of liver injury when using Veoza (fezolinetant), a medicine used to treat moderate-to-severe hot flushes or night sweats associated with menopause. Read more in our highlights (link below in comment section). #antibiotics #pharmacovigilance #womenshealth 

📢 The European Shortages Monitoring Platform (#ESMP) is live! The platform is now available to marketing authorisation holders, who will be able to submit data on shortages of centrally authorised human medicines in the ESMP. ESMP is an important regulatory tool that will: 🔸 gather comprehensive information on the availability, supply and demand of human medicines 🔸 help to detect, prevent and manage shortages in the EU and the EEA 🔸 facilitate communication between EMA, national competent authorities and industry to ensure medicines are available for those who need them.   Learn more about what’s next for ESMP from our news announcement (link in comments). #publichealth #shortages #medicines #healthunion