HTA provides statement on regulation of blood as a starting material for ATMPs

The Human Tissue Authority (HTA) has provided a statement on its website to clarify the regulatory status of blood when used as a starting material for the manufacture of ATMPs.

The statement is a reflection of the fact that blood for use as a starting material for ATMP manufacture has been collected under the EU Tissues and Cells Directive (for which the HTA is responsible for the implementation in the UK) and the EU Blood Directive (for which the MHRA is responsible in the UK).

As an interim position, the HTA and MHRA have agreed to extend the existing policy relating to dendritic cells to allow that collection of blood as a starting material for an ATMP may be performed under either a Tissues and Cells or Blood Establishment Licence. This position may be subject to revision pending legal opinion from the EU Commission.

Author: Anthony Lodge

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