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.
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 details the responsibilities and regulatory requirements for Human Tissue Authority Designated Individuals.
An application to vary a licence can be made by either the DI or the LH / CLHc, with the exception of a change of DI which needs to be submitted by the LH / CLHc.
