The HTA has developed guidance which all establishments in the human application sector should read, on The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018. This guidance was updated following feedback from Department of Health’s consultation on the draft Regulations.
The guidance contains key information on how the Directives will affect particular groups of establishments, such as:
- private tissue banks/establishments that store tissues and cells for potential future use;
- commercial importers and distributors;
- haematopoietic stem cell (HSC) registries and transplant centres;
- tissue banks; and
- establishments that procure starting material for the manufacture of Advanced Therapy (Investigational) Medicinal Products (AT(I)MPs).