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Our role in regulating tissues and cells

The transplantation of human tissues and cells is a growing field of medicine which offers great opportunities for the treatment of diseases.;

Blood stem cells from bone marrow or blood donated to cancer patients, reproductive cells (eggs, sperm, and embryos) used in fertility treatments, skin grafts can be used in the treatment of burns and replacement corneas can be used to restore sight.

As such it is important that the tissues and cells used in these treatments are of a set quality and safe for use.

What activities fall under quality & safety legislation in Ireland?

Any site, such as hospitals, assisted reproduction centres, clinics, that perform any of the following activities with tissues/cells fall within the scope of the legislation for which the HPRA is responsible:

  • Donation
  • Procurement
  • Testing
  • Processing
  • Preservation
  • Storage
  • Distribution
  • import and export

What are Tissue Establishments?

'tissue establishment' is a tissue bank or a unit of a hospital or another body where activities of processing, preservation, storage or distribution of human tissues and cells are undertaken. It may also be responsible for procurement or testing of tissues and cells.

An 'importing tissue establishment' is a tissue bank or a unit of a hospital or another body established within the European Union which is a party to a contractual agreement with a third country supplier for the import into the European Union of tissues and cells coming from a third country intended for human application.

How does the HPRA regulate Tissues and Cells?

We are the Competent Authority responsible for the regulation of tissues and cells in Ireland.

We are responsible for:

  • Implementation of the tissue and cell legislation.
  • Inspection and authorisation of tissue establishments and importing tissue establishments.
  • Receipt, evaluation and follow up of serious adverse reactions and events.
  • Review and approval of one-off notifications for import/export of tissues and cells.

With certain exceptions, requirements relating to the quality and safety for human tissues and cells are set out in Statutory Instrument No. 158 of 2006 (Quality and Safety of Human Tissues and Cells) Regulations.