Professional

The HTA regulates establishments in England, Wales and Northern Ireland that conduct licensed activities under the Human Tissue Act 2004 (HT Act). This includes establishments that remove samples from the deceased for certain purposes in the HT Act – called scheduled purposes.

The Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) (the Q&S Regulations) and the Blood Safety and Quality Regulations 2005 define ‘blood component’ as ‘a therapeutic constituent of human blood (red cells, white cells, platelets and plasma) that can be prepared by various methods’.

The HTA and MHRA have agreed to extend their existing policy relating to dendritic cells to allow collection of blood as a starting material for an ATMP to be performed under either a Tissues and Cells or Blood Establishment Licence.

This will make it more straightforward to procure blood and increase the number of sites in the UK where this activity can occur without increasing the number of licences required. 

Advance Therapy Medicinal Products (ATMPs) are medicinal products which are prepared industrially or manufactured by a method involving an industrial process. ATMPs fall into three categories; Gene Therapies, Somatic Cell Therapies and Tissue Engineered Products.

RASRM is a ‘one stop shop’ for research and development professionals across academia, industry, and the NHS. It offers a single point of access to free, clear, expert responses to queries about the regulation of regenerative medicines.