8/12/2023 0 Comments Cord blood definition![]() It is important to note that EU countries can always choose to apply more stringent rules to the quality and safety of tissues and cells then the ones outlined above.įollowing an evaluation of the EU legislation on blood and tissues and cells, published in 2019, the Commission has proposed a revision of this legislation which was adopted on 14 July 2022. Commission Directive 2015/566 implementing Directive 2004/23/EC concerns the procedures for verifying the equivalent standards of quality and safety of imported tissues and cellsĬommission Decisions 2010/453/EC and Commission Directive 2012/39/EU, as well as Commission Decision C(2015) 4460 address some further specific aspects.Commission Directive 2015/565 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells.Commission Directive 2006/86/EC concerning traceability requirements, notification of serious adverse reactions and events, additional technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells.Commission Directive 2006/17/EC regarding certain technical requirements for the donation, procurement and testing of human tissues and cells.To help implement this basic act, the Commission proposed and adopted, in close collaboration with EU countries, the following implementing Directives: It covers all steps in the transplant process from donation, over procurement, testing, processing, preservation, storage to distribution. The legal framework defining the safety and quality standards for tissues and cells is set out in Directive 2004/23/EC, also referred to as the European Tissues and Cells Directive, adopted in 2004 by the European Parliament and Council. Ongoing and completed EU-funded actions.Actions aim at supporting the EU mandate on safety and quality, but can also serve to promote other policy priorities, such as improving the availability of SOHO or the efficiency of the health systems that support donation and supply. ![]() ![]() The European Commission provides funding for Actions in the area of SoHO mainly in the form of projects or joint actions with national authorities. Other invaluable uses of human tissues include skin grafting for burn victims, or corneal grafting to restore sight.īone marrow (haematopoietic stem cells) and gametes (sperm, egg cells) for IVF can be donated by living donors, while replacement tissues (like skin, bone, cornea or heart valves) can be donated after death. Both are well known medical therapies that use human cells. The use of tissue and cell-based medical treatments is rising in both number and frequency thanks to significant advances in biotechnology.īlood-forming stem cells are transplanted from bone marrow donors (or cord blood) to patients with blood cancer, and/whereas gametes are used for in vitro fertilisation (IVF). ![]()
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