Five years, two products: is the EU's advanced therapies legislation working?
This article was originally published in Scrip
Executive Summary
In five years, the EU's advanced therapies Regulation seems to have done as much to discourage as to encourage research into products based on tissues, cells and gene therapy. Just two products have been approved since the Regulation's provisions took effect in December 2008, largely, it would seem, as a result of inflexibility, excessive regulation, unequal implementation across Europe, and a general lack of clarity and guidance.