The EU regulatory landscape of non- biological complex drugs

Abstract

Non-biological complex drugs (NBCDs) present today and in the future therapeutic opportunities to, inter alia, target the delivery of active ingredients, reduce toxicity and improve efficacy. It has been widely debated whether the EU regulatory system is ready to embrace this group of medicinal products. This chapter introduces the EU pharmaceutical legislation and explains how NBCDs are already integrated into the existing legislative framework. Supported by a recent example of legislative measures constructed purposefully to account for a new class of medicinal products (Advanced Therapy Medicinal Products), we explain what is currently done by EU competent authorities to foster the development of NBCDs and what are the options and challenges faced by the regulatory system to evolve in parallel with the progress made with this innovative and promising class of medicinal products.