A common EU approach to data transparency in medicine regulation

On April 12, 2024, EMA and HMA published an updated guidance on identifying commercially confidential information (CCI) and personal data in marketing authorisation applications for human medicines. The revised guidance aims to promote a more transparent and consistent approach across the European Economic Area (EEA), with the majority of data in marketing-authorisation applications considered releasable, subject to specific exceptions related to manufacturing and contractual information.