Regulation

Advanced therapies comprise cell therapy, gene therapy and tissue engineering. For the most part, these are considered a special type of medicinal products. The only exception is the cell therapy which is considered as a cell transplant and not as a medicinal product when the cells are not subject to substantial manipulation and are used to carry out their normal function or essential functions.

Below, you can find a selection of the main Spanish regulations (Acts, Royal Decrees and Orders) and European regulations (Directives and Regulations) that regulate both the basic, preclinical and clinical research in these kind of products and their quality and manufacturing aspects and their marketing or clinical use.