Procurement, handling and transplant of tissues and stem cells

DEFINITIONS

Allogeneic use – cells and tissues are removed from one person and used in another person.

Autologous use – cells and tissues removed from a person are used in that same person.

Cell – individual human cells or a collection of human cells when not bound by any form of connective tissue.

Distribution – transportation and delivery of tissues or cells intended for human applications.

Donation – the voluntary donating of cells and tissues for transplantation, manufacture of advanced therapy medicinal products or making hospital-exemption medicinal products.

Donor – a person from whom cells or tissues are removed for transplantation, manufacture of advanced therapy medicinal products or making hospital-exemption medicinal products.

Handling – the description, coding, labelling, testing, preservation and processing of cells and tissues and the packaging, labelling, storage, release and distribution of handled cells and tissues to the transplanter, manufacturer of advanced therapy medicinal products or maker of hospital-exemption medicinal products.

Procurement – the process in the course of which cells and tissues are made accessible for handling, transplantation, manufacture of advanced therapy medicinal products or making hospital-exemption medicinal products.

Recipient – a person to whom the cells or tissues removed from a donor are transplanted.

Tissue – all constituent parts of the human body formed by cells.

Transplant – separately packaged and transplanted tissue. It is important to distinguish if units from one procured tissue were transplanted to more than one patient.

Transplantation – the implantation of cells and tissues removed from a donor for therapeutic purposes.

METHODOLOGY

The aim of collecting and producing statistical data on procurement, handling and transplant of tissues and stem cells is to provide an overview of the procurement and handling activities and to illustrate the changes and trends in the handling volumes.

The data are collected in accordance with the Procurement, Handling and Transplantation of Cells, Tissues and Organs Act and decree by the Minister of Health and Labour.

Procurers and handlers of cells and tissues shall submit reports to the Estonia State Agency of Medicines. The deadline for data submission is 1 April. Up to date information about procurement and handling activity licences can be found from State Agency of Medicines’ activity licence registry.

The data is published in absolute figures.

LINKS

Additional information can be found on State Agency of Medicines’ website. The statistics about tissues and cells is also published State Agency of Medicines’ website. All information about statistics is only available in Estonian on the State Agency of Medicines’ website.

CONTACT

Siim Suutre

State Agency of Medicines

Phone: +372 737 4140

E-mail: siim.suutre[at]ravimiamet.ee

 

Updated: 14.11.2022