A Decade of Innovation: Medicinal Products with New Active Substances Centrally Authorized Within EU Between 2011 and 2020

Background: Pharmaceutical innovation plays a vital role in advancing global health. This study evaluates the landscape of pharmaceutical innovation in the European Union (EU) over the 2011-2020 decade. Methods: A retrospective analysis was performed on new medicinal products containing new active substances (NAS) authorized between 2011 and 2020 through the centralized procedure. Products were categorized in first-in-class, advance-in-class, and addition-to-class. Trends in therapeutic areas (ATC codes), orphan designation, technology platforms etc), administration routes, and dosage forms were analyzed. Results: Across the decade, 357 new medicinal products received authorization. Of these, 56% were designated as first in class and 28% as advance in class, indicating that 84% of new products contributed substantive therapeutic innovation. Small molecules remained the predominant technology (63.5%), yet the decade also wit-nessed a pronounced expansion in monoclonal antibodies and the introduction of cell and gene therapies (Advanced Therapy Medicinal Products, ATMPs). The increased use of subcutaneous delivery systems, particularly for monoclonal antibodies, suggests a broad-er move toward patient centered administration routes. Conclusion: Between 2011 and 2020, pharmaceutical innovation in the EU was distinguished by a high rate of break-through innovation and a transition to more sophisticated biologic therapies. EU could boost innovation further by refining expedited approval pathways (e.g., PRIME).