The eleventh meeting of the Member State Coordination Group on Health Technology Assessment (HTACG) set up by Regulation (EU) 2021/2282 was held on 28 November 2024 in Brussels. The meeting covered the following points: 1)...
The Annual 2025 Work Programme has been adopted on 28 November 2024 by the HTA Coordination Group pursuant to Article 6 of Regulation (EU) 2021/2282 on Health Technology Assessment. Read the news announcement published by Directorate-General for...
Today, the European Commission adopted an implementing regulation setting out the rules for joint scientific consultations on medicinal products for human use at Union level, under the Health Technology Assessment (HTA) Regulation. Read the e-News published...
Chaque année en France, environ 130 000 personnes sont hospitalisées suite à des effets indésirables suspectés d’être dus à un mauvais usage des médicaments, dont 10 000 décès. Près de 80% des français.es ont recours...
EMA is initiating a new pilot programme for the expert panels to support manufacturers manufacturing and notified bodies certifying orphan medical devices with the challenges linked to generating clinical evidence for these devices in the...
The Eleventh Industry Standing Group (ISG) meeting, which took place on 21 November 2024, focused on strengthening the collaboration between the EMA and industry stakeholders. Key topics addressed during the meeting included: Implementation of extended...
This meeting focused on: transitional measures to implement the new variation regulation; ePI pilots readout, learnings and next steps; focus group on cancer medicines pathfinder regulatory interactions. The meeting also informed on and discussed the...
15 November 2024 the he EU-Innovation Network (EU-IN) and the Italian Medicines Agency (AIFA) organised a multi-stakeholder meeting to discuss how innovation in the development of Advanced Therapy Medicinal Products (ATMPs) can be translated into...
A report exploring the potential advantages and challenges of leveraging social media data in regulatory decision-making is available. The report specifically focuses on the use of social media data in real-world settings, such as clinical...
European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) were hosting a workshop on AI the 5 November 2024. The workshop aimed to provide updates on: the state-of-the-art of AI developments with keynote speakers;...
