NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Flipper,

From: The expanding role of the clinical haematologist in the new world of advanced therapy medicinal products
Mark W. Lowdell
Amy Thomas

“Taking the UK as an example, the Medicines and Healthcare products Regulatory Agency (MHRA) is the agency with the statutory right to determine whether the product is an ATMP or a cell therapy, which would then be regulated under the EU Tissues and Cells Directives (EUTCDs). This is not a trivial decision, as even minimally manipulated therapies might be classified as an ATMP if the cells will be used ‘non-homologously’, i.e. not intended to be used for the same essential function(s) in the recipient and the donor – even when the cells are used autologously.”……..

“The EUTCD is the legislation with which all HSCT haematologists are familiar as it is the basis of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations). Under these Regulations, the Human Tissue Authority (HTA) licenses and inspects establishments that undertake the procurement, testing, processing, storage and distribution of human cells and tissue for therapeutic use and this authority extends to licensing procurement of human cells and tissue for manufacture of an ATMP. This piece of legislation, requiring licensing of procurement of human cells and tissues, is unique to the EU. The US Federal Drug Administration regulates the manufacture and supply of cell-based medicines and the Australian Therapeutic Goods Administration regulates ATMP equivalents as ‘biological medicines’ but neither yet requires licensing of the clinical site where the patient or donor cells/tissues are procured.”
https://onlinelibrary.wiley.com/doi/full/10.1111/bjh.14384