EU Life Sciences Reforms: The Evolving Landscape for Clinical Development, Market Access and Manufacturing

We are pleased to share our client update on a coordinated package of EU legislative and policy reforms affecting the life sciences sector.

The update reviews proposed and ongoing changes spanning clinical trials, medicinal product marketing authorisations, medical devices and IVDs, combined studies, regulatory sandboxes and incentives for certain biotechnology products, including a proposed SPC extension and additional market protection incentives.

It also considers why these developments may be increasingly relevant for companies conducting EU clinical studies, seeking EU market access, or engaged in EU based manufacturing, including Israeli companies with material EU activities.