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Guidance for establishments on meeting HTA licensing requirements for the procurement of tumour samples to be used as a starting material in the manufacture of an Advanced Therapy Medicinal Product (ATMP).
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”.
The aim of regulating human embryonic stem cells is to ensure that the highest standards are met from their derivation in the laboratory through to their clinical application.
The Designated Individual (DI) at the licensed establishment is responsible for ensuring suitable practices take place under the authority of the Human Tissue Authority (HTA) licence.
According to the 2013 House of Lords report on Regenerative Medicine, the term ‘regenerative medicine’ refers to methods to replace or regenerate human cells, tissues or organs in order to restore or establish normal function.