WHAT IS THE AIM OF THE REGULATION?
Regulation (EU) 2024/1938 introduces new rules that set higher standards in the European Union (EU) for the safety and quality of substances of human origin (SoHO), such as blood, tissues and cells, creating a unified framework to make SoHO more accessible and reliable for everyone involved in healthcare. In particular, the regulation aims to:
- support the continued provision of SoHO therapies, based on high safety and quality standards;
- extend protective measures to new groups of patients, to donors and to offspring born from medically assisted reproduction;
- improve harmonisation across EU Member States, facilitating the cross-border exchange of SoHO and improving patient access to therapies;
- create conditions for safe, effective and accessible innovation;
- improve crisis preparedness and resilience to safeguard access to therapies;
- implement digital-ready policies;
- contribute to the European health union by pooling technical expertise and achieving economies of scale.
KEY POINTS
The regulation applies to a broad range of human-origin substances, defined as any substance collected from the human body, whether it contains cells or not and whether those cells are living or not, including SoHO preparations resulting from the processing of such substances. These include:
- blood and blood components;
- tissues and cells, including stem cells from bone marrow, peripheral blood or umbilical cord blood;
- reproductive cells and tissues, such as embryos and gametes;
- other human-origin substances, like breast milk, intestinal microbiota and non-transfusion blood products.
Unified EU framework
The regulation seeks to harmonise standards and facilitate the exchange of human-origin substances across Member States. Key features include the following.
- SoHO competent authorities. Each Member State must designate a supervisory authority to oversee SoHO activities. These authorities will operate transparently, free from external influence, and in the public interest.
- EU-wide procedures. Common procedures for authorising and evaluating SoHO preparations will simplify the process and improve consistency across borders.
- Stricter oversight. Establishments involved in processing and storing, releasing, importing or exporting SoHO need to meet additional authorisation and inspection requirements.
- Coordination at the EU level. A SoHO coordination board is set up to help Member States implement the regulation effectively.
- New IT platform. The EU SoHO platform is set up to register activities and facilitate information sharing across the EU. The technical specifications for the EU SoHO Platform are provided by Commission Implementing Regulation (EU) 2025/1467.
- Rapid alerts. A quick-response system is in place to manage serious incidents or reactions that could endanger donors or recipients.
Responsibilities of SoHO entities
Legally established organisations involved in SoHO activities will need to meet the following obligations.
- Registration. All SoHO entities must register before starting activities that affect the quality, safety and effectiveness of SoHO.
- Quality systems. Entities must establish and maintain a quality management system tailored to their activities.
- Responsible person. A designated individual within the organisation will ensure compliance with the regulation.
- Data reporting. Entities must collect and report data related to their SoHO activities.
Donors, recipients and offspring from medically assisted reproduction
The regulation places a strong focus on the safety and dignity of both donors and recipients, by expanding the scope of previous legislation to ensure better protection for donors and recipients.
- Donors. Living donors’ health must be protected before, during and after donation. They should receive detailed information about the donation process, and their rights to privacy, non-discrimination and data protection are safeguarded.
- Recipients and offspring from medically assisted reproduction. SoHO entities must minimise risks to recipients and offspring from medically assisted reproduction, ensuring that the substances used are safe and of high quality.
The regulation emphasises that SoHO donations should be voluntary and unpaid. While donors may receive compensation or reimbursement for expenses, financial incentives for donating are prohibited in order to maintain ethical practices.
Critical SoHO
Insufficient supply of critical SoHO could result in serious harm or risk of serious harm to patients’ health and serious interruption in the manufacture of products regulated by other EU legislation. To avoid shortages, Member States are required to:
- make reasonable efforts to ensure a steady and resilient supply;
- create national emergency plans to address potential supply disruptions.
Evaluation
The European Commission will, by 8 August 2032, assess the application of this regulation, produce an evaluation report on the progress towards achieving its objectives, presenting its main findings to the European Parliament, the Council of the European Union, the European Economic and Social Committee and the Committee of the Regions.
FROM WHEN DOES THE REGULATION APPLY?
Most provisions will apply from 7 August 2027, with some exceptions that will apply either earlier or later.
The regulation replaces and repeals Directives 2002/98/EC (see summary) and 2004/23/EC (see summary) effective from 7 August 2027, with detailed transitional arrangements in effect.
BACKGROUND
For further information, see:
MAIN DOCUMENT
Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 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 (OJ L, 2024/1938, 17.7.2024).
Successive amendments to Regulation (EU) 2024/1938 have been incorporated into the original text. This consolidated version is of documentary value only.
RELATED DOCUMENTS
Commission Implementing Regulation (EU) 2025/1467 of 18 July 2025 laying down rules for the application of Regulation (EU) 2024/1938 of the European Parliament and of the Council as regards the technical specifications for the EU SoHO Platform to exchange information concerning substances of human origin intended for human application (OJ L, 2025/1467, 21.7.2025).
Regulation (EU) 2021/240 of the European Parliament and of the Council of 10 February 2021 establishing a Technical Support Instrument (OJ L 57, 18.2.2021, pp. 1–16).
Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, pp. 39–98).
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, pp. 1–175).
See consolidated version.
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, pp. 1–88).
See consolidated version.
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, pp. 1–76).
See consolidated version.
Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, pp. 121–137).
See consolidated version.
Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (OJ L 294, 25.10.2006, pp. 32–50).
See consolidated version.
Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, pp. 48–58).
See consolidated version.
Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, pp. 30–40).
See consolidated version.
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, pp. 67–128).
See consolidated version.
