[Chapter 2. Clinical trials of advanced therapy medicinal products: which future for the European regulation]

In relation to the ?hot? topic of regenerative medicine, European Union law established a specific legal framework for advanced therapy medicinal products, manufactured from human or animal genes, cells or tissues. However, these medicinal products do not have always to be submitted to clinical trials as legal requirements vary according to the intended use: market of the whole of Member States, compassionate use, and hospital exemption. Moreover, specificities of these medicinal products make clinical trials difficult to be conducted. This paper highlights the consecutive competition between regulations and products that takes roots in the tension between the challenges of patients' safety and quick access to innovative treatments. It also shows the regulatory flexibility currently favored to ensure the necessary balance between safety and availability, is not without limits.