Human Tissue Authority

The regulator for human tissue and organs

Regulation of Blood as a Starting Material for ATMP Manufacture

The HTA and MHRA have agreed to extend their existing policy relating to dendritic cells. This extended policy will 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 policy has been adopted as an interim position and may be subject to revision pending legal opinion from the European Commission.

The policy is available to view here.

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