The document outlines key regulatory challenges currently impacting Life Science Manufacturers Association (LSMA) members, hindering innovation, increasing costs, and affecting competitiveness within the EU and globally. This paper does not consider access to finance or other bottlenecks within biomanufacturing.
We aim to provide concrete examples and highlight areas where a more proportionate, harmonised, and risk-based approach to regulation would foster a more robust and competitive European life sciences ecosystem, as well as improved access to affordable healthcare for the European public. In this, we have aimed to put forward suggestions that retain the objectives of relevant EU policies currently under review or planned revision, while ensuring an environment that is strong for companies. While this list is not exhaustive, LSMA remains available to elaborate further on the points listed below.
