Life Sciences Horizons Brochure 2025 - Flipbook - Page 103
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2025 Horizons Life Sciences and Health Care
New EU rules on human blood, tissues, and cells
In 2024, EU legislation on human blood, tissues, and
cells saw a major change with the adoption of the new
Regulation (EU) 2024/1938 on standards of quality
and safety for substances of human origin intended
for human application (“SoHO Regulation”). This new
Regulation will apply from 7 August 2027, replacing
the rules that have governed the use of human blood,
tissues, and cells in the EU for more than 20 years.
The SoHO Regulation will have a broader scope and cover all
SoHO, defined as any substance (and preparations thereof)
collected from the human body, whether or not it contains
cells and whether those cells are living or not. This will capture
substances such as intestinal microbiota and blood preparations
not used for transfusion that were outside the scope of the current
legislation, as well as other substances for which clinical use may
emerge in the future.
The SoHO Regulation will also cover SoHO used to manufacture
medicinal products and medical devices, making it a key piece of
legislation for companies operating in these sectors.
Numerous other changes have been introduced. Amongst them
is the new SoHO Coordination Board (SCB), which will provide
opinions on the regulatory status of substances, products, or
activities. The hope is that this new body will bring more legal
clarity for developers of borderline and combination therapies,
as well as remove some of the challenges to cross-border
exchanges of SoHO.
Another main objective of the SoHO Regulation is to facilitate the
development of innovative therapies. For this purpose, a new
risk-based authorization model was introduced for SoHO
preparations, requiring developers to provide clinical evidence
proportional to their level of innovation and risk.
Guidelines issued by the European Centre for Disease Prevention
and Control (ECDC) and the European Directorate for the Quality
of Medicine & Healthcare (EDQM), already widely applied in the
sector, will now have a reinforced role and constitute the primary
means to meet the SoHO Regulation standards. These guidelines
incorporate the latest scientific evidence and are regularly
updated, which shall allow the SoHO framework to stay aligned
with technological advancements and evolving risks.
Learning lessons from the COVID-19 pandemic, there will also be
new rules on supply continuity, including the establishment of
emergency plans and certain obligations for entities dealing with
critical SoHO, as we dissect deeper online here.
Cláudia Mendes Pinto
Senior Associate
Brussels
