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

摘要

In Europe the issue of regulation of safety and quality of tissue grafts was first discussed at the EATB meetingin Leuven in 1995. In the years 2004 and 2006 the pertinent Directives of the European Parliament and Counciland of the European Commission were issued. In the Czech Republic the harmonized national legal normswere issued in 2008 and the State Institute for Drug Control was authorized to grant licences for activities ofTissue (TE) and Procurement (PE) Establishments. The TE of the University Hospital Hradec Kralove wasgranted this licence in 2011.The harmonization process lasted 22 years and was completed in 2017, when theTE was put on the list of the EU Tissue Establishments (EUTE). The TE was given three EUTE identificationcodes: CZ 000425 for reproductive tissues, CZ 000426 for haematopoietic tissues and CZ 000427 for othertissues, such as vascular tissues, bones, ligaments, tendons or amnia.