Gaps exist in regulatory science that need to be addressed to improve medicine development and evaluation, ultimately to enable access to innovative medicines that address patients’ needs. The European Medicines Agency (EMA) has outlined approximately one hundred topics in its published "Regulatory Science Research Needs" list. By sharing this list, the EMA aims to encourage researchers and funding bodies to integrate these priorities into their projects and initiatives. The list is periodically updated to include new topics and relevant research references.
A fully updated version of the list of regulatory science research needs is available for public consultation until 18 December. It also includes a change in the structure of the list to highlight needs, focus areas and priority topics. All stakeholders are invited to provide their feedback, including suggestions for regulatory science gaps.