After five years from its launch, the European Medicines Agency published an interim report on the mid-term achievements of the Regulatory Science Strategy to 2025.
“The achievements highlighted in this report demonstrate that we have made considerable progress in advancing regulatory science to build a more adaptive regulatory system that encourages innovation in human and veterinary medicines,” said Emer Cooke, EMA’s Executive Director.
Five main areas of innovation for human medicines and three for veterinary products have been identified. Areas of progress for the human domain include fostering innovation in clinical trials; promoting use of high-quality, real-world data in decision making; reinforcing patient relevance in evidence generation; contributing to health technology assessment bodies’ (HTA) preparedness and downstream decision making for innovative medicines; and supporting developments in precision medicine, biomarkers and ‘omics. In the veterinary domain, actions were taken to transform the regulatory framework for innovative veterinary medicines. The development of new approaches to improve the benefit-risk assessment of veterinary medicinal products and the collaboration with stakeholders to modernise veterinary pharmacoepidemiology and pharmacovigilance were other key areas of attention.