In more detail 

Introduction

On 17 July, the Regulation (EU) 2024/1928 on standards of quality and safety for substances of human origin intended for human application ("SoHO Regulation") was published in the Official Journal of the European Union. This new Regulation offers a wider and more exhaustive set of standards in relation to Substances of Human Origin ("SoHO"), until now contained in Directive 2002/98/EC, on setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components, and Directive 2004/23/EC, on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells ("Directives"), which will be repealed. One of the main novelties is the harmonization of the regulations in a single text, which provides a complete and uniform regulatory framework for Member States, avoiding divergence and different criteria on a national level. The SoHO Regulation will be applicable from August 2027 and will establish a regulatory framework with minimum provisions, without prejudice to Member States deciding to adopt more rigorous measures than those contained in these new legislation.

A broader scope

One of the most important aspects of the SoHO Regulation is its scope of application. From now on, and breaking with the diversity of regulatory sources existing to this date, we will have a regulation that aims to cover all types of substances of human origin in a single regulatory text. By way of example, the new SoHO regulation will apply not only to blood and blood components, human tissues and cells, which were already subject to previous regulation, but also to breast milk, intestinal microbiota and blood preparations that are not used for transfusion purposes.

Notwithstanding the above, this new regulation still maintains the premise that only substances that involve a biological interaction with the human body will be understood to fall within its scope. Nevertheless, the SoHO Regulation also includes an open clause mentioning "any other SoHO that may be applied to humans in future", so it is foreseeable that the list of substances will be extended in the forthcoming years.

Higher safety and quality standards

From a safety perspective, the SoHO Regulation seeks to extend its protective nature to individuals who were not previously considered. Under the previous Directives there was a risk of leaving certain groups of people unprotected due to the lack of regulation of certain SoHO. This situation has been remedied by, the SoHO Regulation, which shall be applicable to both donors and offspring born from medically assisted reproduction techniques, guaranteeing them a high standard of protection.

By introducing the relevant authorization as a prerequisite, higher safety standards are upheld. We would like to highlight the following:

• Any processing of SoHO that includes its transformation is subject to an appropriate level of supervision, in addition to the obligation to obtain authorization for its distribution and application.
• Laboratories and departments responsible for quality controls shall be registered as SoHO entities.
• New further criteria and conditions must be considered as to importation and exportation activities involving SoHO. In the case of import, the quality, safety and efficacy of the SoHO must be formally verified. For export, however, a release is required to confirm the quality and safety of the products.

Moreover, the SoHO Regulation regulates high safety and quality standards in comparison to what has been achieved to date. The quality standards is intended to be achieved by future technical guidelines prepared by the European Directorate for the Quality of Medicines & HealthCare and the European Centre for Disease Prevention and Control in relation to the prevention of the transmission of communicable diseases and the protection of recipients of SoHO – to be completed and developed by specific agencies – based on scientific knowledge and up-to-date scientific evidence.

Procedural and institutional novelties

The new SoHO Regulation establishes the obligation for Member States to designate competent and independent authorities to carry out the following activities in the field of SoHO:

• To authorize SoHO preparations.
• To perform SoHO supervisory activities.
• To ensure coordination and communication with the European Commission, other Member States, and their respective national authorities.

Finally, and regarding the abovementioned objective of reaching a better communication between the subjects that fall under the scope of the SoHO Regulation, an ad hoc online platform shall be established – the "EU SoHO Platform" – in order to offer a centralized manner to exchange data and information.

The full content of the SoHO Regulation is available by clicking on the following link. For more information or in case you need individual advice for your company, please contact our team of experts.