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.
This page provides information about the Human Tissue Authority (HTA) regulatory assessment process.
Advance Therapy Medicinal Products (ATMPs) are medicinal products which are prepared industrially or manufactured by a method involving an industrial process. ATMPs fall into three categories; Gene Therapies, Somatic Cell Therapies and Tissue Engineered Products.
RASRM is a ‘one stop shop’ for research and development professionals across academia, industry, and the NHS. It offers a single point of access to free, clear, expert responses to queries about the regulation of regenerative medicines.
The Human Tissue Authority (HTA) has today launched the beta (draft) version of our new website and we want your feedback!
The new website is part of our ongoing commitment to enhance the quality and accessibility of the information we provide to professionals working in areas we regulate, and members of the public who our regulation protects.
There are two ways you can give your feedback about the new site:
The following guidance has been issued to set out the HTA’s expectations regarding the use of alternative reagents and materials during the processing of tissues and cells in the event there is a supply disruption to critical reagents and materials as a result of the UK exiting the EU.
HTA licensed establishments in the Post-mortem sector are required to report incidents to the HTA - we call these HTARIs - and those in the Human Application and Organ Donation and Transplantation sectors are required to report serious adverse events or reactions (SAEARs), as part of their licensing requirements.
In line with the HTA's commitment to transparency, we will be publishing reports every quarter detailing the volume and nature of incidents reported.
Under the Enterprise Act 2016, the HTA and all other statutory regulators have a duty to report against the Government’s Business Impact Target. The target for the 2015-2020 Parliament is a £10 billion reduction in the cost of regulation to business.
The objectives of the BIT are to:
