Body, organ and tissue donation
Information on the body, organ and tissue donation procedures we regulate.
Human application
Innovation in the round – the HTA’s cells and tissues partner discussion
In our last blog, the HTA outlined how we and our stakeholders have a clear role to play in achieving the governments’ Life Sciences Vision, together delivering a progressive UK regulatory offer that unlocks innovation while safeguarding patients and ensuring public confidence. To do this, we need to constructively challenge our regulatory model and tools, looking at how we&nbs
Annual activity data collection
All establishments licensed to carry out activities under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 must submit data relating to the activities undertaken and the tissue types worked with between 1 January and 31 December on an annual basis.
Submission of the data is a condition of your HTA licence.
Innovation in regulation – the start of a critical conversation
Earlier this year the Minister for Innovation laid out a challenge to health regulators, the Professional Standards Authority, NICE and NHSX during an unprecedented roundtable. If the post-Brexit ambition, as outlined in the government’s Life Sciences Vision, is to provide a world-class regulatory environment that benefits patients and the public while also promoting jobs, growth, and investment, how do we collectively
Regulatory alerts
Read through the latest regulatory alerts and updates issued by the HTA.
HTA Legislation: Powers, Consent and Licensing
This page provides a summary of the key pieces of legislation, licensing frameworks, and a brief overview of responsibilities for Designated Individuals (DIs), Named Contacts (ODT sector only), Persons Designated (PDs) and Licence Holders.
How to become an IA
If you are interested in applying to become an IA, but unsure whether you meet the requirements, you should read the IA role specification (below) and contact the Living Donor Coordinator at your nearest transplant unit in the first instance.
Regulation of dendritic cells and white blood cells other than granulocytes
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’.
Regulation of blood as a starting material for ATMP manufacture
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.