Own Experience from the 22 Year Lasting Process of Harmonization of the European Union Safety and Quality Requirements for Harvesting Processing and Distribution of Human Cells and Tissues Used for Clinical Transplantation
Abstract
In Europe the issue of regulation of safety and quality of tissue grafts was first discussed at the EATB meeting in Leuven in 1995. In the years 2004 and 2006 the pertinent Directives of the European Parliament and Council and of the European Commission were issued.
In the Czech Republic the harmonized national legal norms were issued in 2008 and the State Institute for Drug Control was authorized to grant licences for activities of Tissue (TE) and Procurement (PE) Establishments. The TE of the University Hospital Hradec Kralove was granted this licence in 2011.
The harmonization process lasted 22 years and was completed in 2017, when the TE was put on the list of the EU Tissue Establishments (EUTE). The TE was given three EUTE identification codes: CZ 000425 for reproductive tissues, CZ 000426 for haematopoietic tissues and CZ 000427 for other tissues, such as vascular tissues, bones, ligaments, tendons or amnia.