Newcastle Cellular Therapies Facility

Human Tissue Authority

Human Tissue Authority Licence

The Cellular Therapies Facility holds a Human Tissue Authority (HTA) licence.

Licence ref: HTA Licence No. 11122.

European Union Tissue and Cells Directives

The European Union Tissue and Cells Directives (EUTCD) set out to establish a harmonised approach to the regulation of tissues and cells across Europe.

The Directives set a benchmark for the standards that must be met when carrying out any activity involving tissues and cells for human application (patient treatment). They also require that systems are put in place to ensure that all tissues and cells used in human application are traceable from donor to recipient.

The HTA as one of the Competent Authorities in the UK under the EUTCD, has responsibility for regulating tissues and cells (other than gametes and embryos) for human application. The Human Fertilisation and Embryology Authority (HFEA) is the other Competent Authority in the UK and is responsible for the regulation of gametes and embryos for human application.

When substantial manipulation of cell products is required during manufacture or the cells are required for non-homologous use, these products are classified as Advanced Therapy Medicinal Products (ATMPs). ATMPs are regulated by the MHRA - although donation, procurement and testing remains under the remit of the HTA.