Back Two new Council of Europe recommendations on quality and safety standards for organ, tissue and cell transplantation in Europe

EDQM Strasbourg, France 08/10/2020
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The Committee of Ministers of the Council of Europe has adopted two new recommendations,1 calling on member states to ensure that quality and safety standards for the donation and transplantation or human application of organs, tissues and cells are respected in accordance with the technical guides2 published by the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe.

The recommendations are expected to promote the wider dissemination and use of the EDQM guides, thus ensuring improved health protection for recipients of organs, tissues or cells in Europe.

Standards and guidelines on the quality and safety of organs, tissues and cells of human origin for transplantation have been published by the EDQM since 2002 and are now recognised worldwide as reference documents in the field.

The donation and transplantation of substances of human origin has a significant impact on health. In 2019 alone, 41 000 organs were transplanted in European Pharmacopoeia member states; in other words, 112 transplants were carried out every day and an extraordinary number of lives were saved or significantly improved. For transplants to be successful, however, the highest quality and safety standards, based on solid ethical principles, must be applied.

With these guides, the EDQM/Council of Europe supports health professionals and health authorities with the latest scientific information and contributes to making Europe both a world leader in transplantation and a model for international co-operation on the matter.

The adoption of these recommendations represents an acknowledgment of the important work carried out by the EDQM and of the Council of Europe in this area and provides the European Committee on Organ Transplantation (CD-P-TO) and relevant ad hoc working groups with the legal basis to continue elaborating and updating these guides.

See also:

2. Guide to the quality and safety of tissues and cells for human application; Guide to the quality and safety of organs for transplantation. More information available at