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 you undertook and the tissue types you worked with between 1 January 2024 and 31 December 2024
Data must be submitted via the HTA Portal between 9.00 am Monday 13 January 2025 and 5.00 pm on Monday 31 March 2025.
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
The Human Tissue Act 2004 requires that the removal of tissue from the deceased for research within the scope of the Act must always be licensed, on specified premises, and that specific minimum requirements are met.
This means that if, for example, a person wishes to remove relevant material from a deceased organ donor for research ‘in connection with disorders, or the functioning, of the human body’, the removal must always take place on premises licensed by the HTA for that purpose.
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.
