Over Ten Years Since the Adoption of the EU Regulation on Advanced Therapy Medical Products - Lessons Learned Thus Far

Advanced therapy medicinal products (‘ATMPs’) are a heterogeneous class of modern biotechnology medicines encompassing medicinal products based on genes, cells, and tissues. The European Medicines Agency (the ‘EMA’) and the European Commission issued a joint action plan in late 2017 with the goal of improving the regulatory environment for ATMPs to facilitate the research, development, and approval of these products in the European Union. Regulators around the world are taking measures to create a facilitative regulatory environment that encourages innovation, protects public health, and enables timely patient access to innovative, new therapies whilst ensuring patient safety. In Europe, the role of risk-proportionate adaptations to clinical trials and GMP manufacture along with the EMA’s early-access incentives and initiatives are presented as potential facilitators of market entry.