The use and storage of human tissue and cells has been subject to a licensing regime in the UK since 2004. The Human Tissue Authority (HTA) oversees not only the use of tissues and cells for human application, but also the handling and storage in pathology, educational and research contexts, and the import and export of cells and tissues.
UK human tissue legislation sits alongside a growing body of other laws and requirements that also impact upon the use of tissues and cells. These related frameworks are not always harmonised, and it can sometimes be challenging to navigate the regulatory pathway to take a new cell therapy to market.
We have worked with a large number of companies, biobanks and researchers advising in relation to virtually all aspects of the regulation of tissue and cell therapies.