How will specific somatic cell therapies be regulated?
During the development of your novel somatic cell therapy, you should contact the MHRA to seek classification as a Medicinal Product (MP) or an Investigational Medicinal Product (IMP). If your product is not classified as either of these, then the product will be wholly regulated by the HTA for all licensable activities. If your product is classified as a MP or IMP, then only the donation procurement and testing will be licensed by the HTA. Peripheral Blood Stem Cells All activities involving the donation, testing, procurement, processing and storage of PBSCs fall under the remit of the HTA as defined in Quality & Safety Regulations Paragraph 5 (1).
