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Revision of the Union legislation on blood, tissues and cells
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC
Initiative summary:
The EU legislation provides high safety and quality standards for blood, tissues and cells. The initiative aims to update the current EU rules for scientific and technological developments, including accommodating innovative therapies. It will also address the (re-)emergence of communicable diseases, including lessons learnt from the COVID-19 pandemic, as well as increasing commercialisation and globalisation of the sector, thereby contributing to a stronger health Union.