In April 2023, the European Commission published new legislative proposals to revise the EU’s long-standing pharmaceutical legislation and ensure it can meet the challenges of the future. The revision will redefine the regulatory framework for medicines and have a significant impact on the EU global innovation ecosystem. Small and mid-sized companies are innovation drivers and crucial for R&D. The new legislation comes with some barriers and challenges that are particularly worrisome for SMEs.
LSAA Chairman Rainer Westermann and Advisory Council Member Jan-Philipp Beck, Partner at Vintura Consultancy, discuss what impact this legislation will have on small and emerging companies.