Regulatory Reform Actions for European Healthcare

This document is a guide that outlines six bold actions for regulatory reform in European healthcare. It addresses the challenges faced by Europe in maintaining its competitiveness in healthcare innovation, highlighting a significant investment gap and the need for improved regulatory agility. The guide emphasizes the importance of modernizing the General Pharmaceutical Legislation to enhance regulatory processes. Key proposals include reducing assessment timelines, implementing phased reviews for exceptional therapeutic advancements, and establishing a regulatory sandbox for testing new approaches. The document also discusses the necessity of assigning the European Medicines Agency (EMA) a coordinating role in integrated solutions and ensuring adequate funding and resource allocation for effective regulatory implementation. Furthermore, it advocates for formalizing collaboration and work-sharing practices that emerged during the COVID-19 pandemic to streamline regulatory submissions across different jurisdictions. The ultimate goal is to revitalize Europe's healthcare innovation ecosystem and restore its competitive edge in the global market.