Posted by Michael Wonder on 19 Jul 2020
Advanced therapy medicinal products regulations in the EU
16 July 2020 - This article explains some of the terminology relating to advanced therapy medicinal products, including gene and cell-based therapies, tissue-engineered products, and combined advanced therapy medicinal products.
The author explains the key EU regulations and guidance documents for each therapy type, and discusses marketing authorization, accelerated regulatory pathways, and market access.
He advises companies navigating this complex regulatory environment to engage with the regulatory agencies early and often during the approval process and to seek external regulatory support if in-house resources are limited.
