Background to SoHO Regulation

Substances of human origin (SoHO) means any substance collected from the human body.

On 17 July 2024 the new rules on standards of quality and safety for substances of human origin for use on or in human recipients has been were published.

These new rules will replace the current rules for blood (Directive 2002/98/EC) and tissues and cells (Directive 2004/23/EC).

The types of products covered by these new rules has expanded. Some new substances, which were not previously within the remit of the blood, and tissues and cells legislation, for example, faecal microbiota and human breast milk, are now included and regulated under the SoHO Regulation.

What is the aim of the new Regulation?

The new rules will improve oversight and safety of substances of human origin (SoHO). They will ensure that:

  • Technical rules on quality and safety can adapt to emerging risks and new technologies
  • Protections for donors and offspring are strengthened
  • Oversight across Europe is harmonised
  • Innovation is supported
  • Measures to prevent shortages of blood, tissues and cells are introduced

A new digital platform will also be developed to streamline reporting, information gathering and increase visibility for all citizens.

Registration will be required for all entities that carry out activities that could affect the safety and quality of SoHO.

Access to expertise from the European Centre for Disease Prevention and Control (ECDC) and the European Directorate for the Quality of Medicines and Healthcare (Council of Europe), will help to keep technical guidelines up to date.

How were these new rules developed?

The changes were first put forward by the European Commission in July 2022, following an extensive review process. Voices from a range of stakeholders were included in the development of the new regulation.

More information on the process can be found the Commission's website.

The European Commission has also prepared a Question and Answer Document on the new regulation.

What activities are taking place at the European level to implement the SoHO Regulation?

The SoHO Coordination Board (SCB) was set up in January 2025 to act as an advisory body to support Member States to implement the SoHO Regulation. It provides guidance, advice, and oversight support to national authorities.

In addition to the SCB, six SoHO working groups started meeting in April and May 2025 to support the rollout of the regulation. These working groups are developing guidance and recommendations for people working in the sector that will be reviewed and approved by the SCB.

The working groups are focusing on the following areas:

  • Entity registration
  • SoHO preparation authorisation
  • Inspection
  • Vigilance and traceability
  • Supply
  • Regulatory questions

The HPRA is a member of the SoHO Coordination Board (SCB) and multiple EU working groups to help develop harmonised processes for the new Regulation. The HPRA will continue to review all documents produced by the SCB and will implement the relevant processes to ensure a smooth transition to the new Regulation. 

When will these changes take effect?

Most of the new rules will come into force from 7 August 2027, but some rules won't come into force until 2028.

The HPRA is developing guidelines to help stakeholders comply within those timeframes. These guidelines will include the registration process, how to maintain compliance and other relevant information as part of the implementation plan.