The Human Tissue Authority (HTA) welcomes the publication of the report from the Regenerative Medicine Expert Group, “Building on our own potential: a UK pathway for regenerative medicine”.
Dr Alan Clamp, Chief Executive of the HTA said: “This report is a positive step towards the UK achieving its ambition to lead world class research, manufacture and clinical use of regenerative medicines.
“The HTA wants to see regenerative medicine continue to thrive in the UK. Effective regulation supports this by providing essential safeguards for quality and safety, which in turn leads to improved healthcare.
“We aim to provide clarity and support to organisations working with regenerative medicines and were instrumental the development of the ‘one stop shop’ for advice and guidance on regenerative medicine. We will also continue to work with the MHRA to pilot a streamlined inspection process for those developing Advanced Therapy Medicinal Products.”
- The HTA works to ensure that human tissue and organs are used safely and ethically, with proper consent. Under the European Union Tissues and Cells Directives, it licenses establishments that remove, test, process, store, and distribute tissues or cells that will (or may) be used to treat patients. This includes human tissue or cells used as starting materials in the manufacture of advanced therapy medicinal products (ATMPs).
- The regulatory ‘one stop shop’ was developed by the HTA, Human Embryology and Fertility Authority, Health Research Authority and Medicines and Healthcare Products Regulatory Agency. It aims to help businesses and other organisations quickly and easily navigate the different regulators and allows them to get the right advice more quickly. It also provides a single response from the regulators and provide an opportunity for a one to one meeting.
- The report and further information about the Regenerative Medicine Expert Group can be found on the Government's website.