European health union : new rules for greater safety and quality of blood, tissues, and cells.
Date: 2024-04-08
Institutions: Directorate-General for Health and Food Safety
Subjects: European Health Union, blood transfusion, health policy, quality standard, safety standard, substance of human origin

European Health Union
New rules for greater safety and quality  
of blood, tissues, and cells

Supporting high safety and
quality standards based on
up-to-date technical rules for
substances of human origin
(SoHO)

Extending protective
measures to donors and to
offspring born from
medically assisted
reproduction

Extending the safety
and quality framework
to other donated SoHO
such as breast milk

Implementing
digital-ready
policies

BY 2027

Improving
harmonisation across
Member States,
facilitating cross-border
exchange of SoHO and
improving patient
access to the therapies
they need

Creating conditions for
safe, effective and
accessible innovation

Improving crisis
preparedness to
safeguard access to
therapies

SAVING AND TRANSFORMING LIVES
(FIGURES PER YEAR)

15 MILLION  
blood & plasma 
donors

4,6 MILLION 
patients 
transfused

OVER 200 000 
babies born 
from Medically 
Assisted 
Reproduction

36 000 
stem cell 
transplants for 
blood cancers

OVER 10 000 
cornea 
transplants

650
heart 
valves

THE KEY 
MEASURES

STRENGTHENED LEVELS OF HEALTH
PROTECTION

A wider scope to cover blood, tissues, and cells,
together with other SoHO (like human breast milk or
faecal microbiota)

High standards for safety and quality,
implemented through technical guidelines
developed mostly by expert bodies1 based on  
up-to-date scientific evidence

Renewed commitment to the principle of
voluntary and unpaid donation, protecting donors
from exploitation and from risks to their own health
without discouraging donations

Improved reporting and follow-up on adverse
reactions

FACILITATION OF INNOVATION

Common EU-wide authorisation procedures
for innovative SoHO preparations

Body providing advice on regulatory status of a 
substance or a product

HARMONISATION, SIMPLIFICATION & 
SUPPORT

Implementation of risk-based oversight, for
more efficient use of resources (for authorising
establishments and activities, carrying out of
inspections...)

Application of common technical guidelines
while safeguarding Member States’ possibility
to have more stringent rules

Collection of information on supply, quality
and safety of SoHO for oversight, policy and
research

EU support to Member States through
training for authorities, joint activities and
advisory mechanism

DIGITALISATION

Common IT Platform to facilitate data reporting
and information sharing

1. European Centre for Disease Prevention and Control (ECDC) and European Directorate for the Quality of Medicines and Healthcare (EDQM, Council of Europe)

© European Union, 2023
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PDF   ISBN 978-92-68-10312-8     doi:10.2875/51561    EW-05-23-519-EN-N