Regenerative Medicine and the regulation of Advanced Therapies Medicinal Products (ATMPs)
The procurement and testing of relevant human material, as a starting material for an Advanced Therapies Medicinal Product (ATMP), may require HTA licensing (under the Human Application license and NOT the Research license). This is via the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations) and NOT the Human Tissue Act.
The following information on this site relates to the regulation of relevant research activity under the Research License only and is NOT suitable for use with the above Human Application license relevant activities.
Human Tissue Act
The Human Tissue Act is a framework for regulating the storage and use of human organs and tissue from the living, and the removal, storage and use of human organs and tissue from the deceased, for specified health-related purposes and public display.
Human tissue can be defined as material which has come from the human body which consists of, or includes, human cells.
It aims to make consent a fundamental principle underpinning the use and storage of human tissue.
It is overseen by the Human Tissue Authority (HTA), which regulates the removal, storage, use and disposal of human bodies, organs and tissue.
- Policy for the storage and use of human tissue
- Frequently Asked Questions
- HTA key facts presentation ( Updated April 2021)
- HTA Codes of Practice for Research
- List of materials covered by the act
- HTA newsletters
- LTHT/ UoL Human Tissue Act Standard Operating Procedures
- MRC resources – updated July 2019
- Tissue Transfer Agreements