News Category: Regulatory news
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 published.
Substances of human origin (SoHO) means any substance collected from the human body.
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. Previously unregulated substances, for example, faecal microbiota and human breast milk, are now included.
Improved Oversight and Safety
The new rules 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.
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 will develop guidelines to include the registration process, how to maintain compliance and other relevant information as part of the implementation plan.
Contact Us
If you have any queries in relation to the new regulation, you can email compliance@hpra.ie