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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 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.
Umbilical cord blood may be collected at the time of birth and stored, so that it is available for potential future treatment of the child or another person.
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.