www.ema.europa.eu In 2024, EMA recommended 114 medicines for marketing authorisation. Of these, 46 had a new active substance which had never been authorised in the European Union (EU) before. Among these are a number of medicines that stand out due to their contribution to address public...

www.ema.europa.eu EMA has published the revised version of its policies on the handling of competing interests of scientific committee members and experts (‘Policy 0044’) and of the EMA Management Board members (‘Policy 0058’). These policies set out the ground rules on which EMA involves...

www.ema.europa.eu The regulation also creates an EU framework for the assessment of selected high-risk medical devices to help national authorities to make more timely and informed decisions on the pricing and reimbursement of such health technologies.EMA will support the implementation of...

www.ema.europa.eu EMA and HMA (Heads of Medicines Agencies) have published a comprehensive overhaul of their guidance on the identification of commercially confidential information (CCI) and personal data in marketing authorisation applications for human medicines. The update reaffirms the...

www.ema.europa.eu EMA and the Heads of Medicines Agencies (HMA) have published high-level principles and recommendations for all staff across the European medicines regulatory network (EMRN) using large language models (LLMs) in their work.LLMs are a category of generative AI, whose...