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...
As part of the published Accelerating Clinical Trials in the EU (ACT EU) multi-annual workplan 2022-2026 and acknowledging the important role of international Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)...
The EMA is currently carrying out a public consultation on the Data quality framework for medicines regulation chapter dedicated to real-world data . The chapter under consultation provides guidance on how to assess the quality...
ICH E6(R3) Annex 2 addresses the GCP considerations that arise from the increased use of a wider range of design elements and data sources. Annex 2 provides additional GCP considerations, focusing on examples of trials...
The 15 November 2024, the EMA published for consultation a Draft European Medicines Agencies Network Data Strategy – Increasing the value of data for the benefit of public and animal health. The strategy, co-developed by...
This list of research needs, EMA hopes to encourage researchers and funding organisations to address these needs in their work and programmes. By highlighting these research needs, the goals are to stimulate research in these fields; to encourage...
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...
