This page provides a summary of the key pieces of legislation, licensing frameworks, and a brief overview of responsibilities for Designated Individuals (D...
Advance Therapy Medicinal Products (ATMPs) are medicinal products which are prepared industrially or manufactured by a method involving an industrial proce...
The Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) (the Q&S Regulations) and the Blood Safety and Quality Regula...
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...
Under the Human Tissue Act 2004, any potential donation of bone marrow or peripheral blood stem cells (PBSC) from adults who lack capacity to consent and c...
The following guidance has been produced to bring clarity to the issues surrounding consent for research relating to transplantation where donors are decea...