Updated rules for greater safety and quality of blood, tissues, and cells & microbiome? – Public consultation on a proposal for a new regulation of substances of human origin is open now!
The European Commission has opened a public consultation for a new regulation on substances of human origin (SoHO). The proposed regulation aims to govern how SoHO will be used in human applications in the EU. Besides blood, tissues and cells, the new regulation, for the first time, will include other substances such as breast milk and human microbiomes.
In July 2022, the European Commission proposed new rules to increase the quality and safety of donating or receiving SoHO in human applications. After revision of the current directives on blood, tissues and cells enacted in the early 2000s, this new regulation is set to close important gaps in the way SoHO have been handled up to now. To match the scientific developments and needs of European citizens, the proposed regulation supports up-to-date safety and quality standards, ensures adequate donor informed consent, implements digitalization, and harmonizes procedures among EU member states.
The new regulation recognises the importance of other substances of human origin and for the first time includes all human microbiomes. Based on the regulation proposal, rules for collecting, testing and administering human microbiomes will be set. This new framework should enable the creation of standardised approaches in administering human microbiomes or using them as starting material in a wide range of finished products (i.e., medicinal products, medical devices, food products, etc…).
Human Microbiome Action encourages all microbiome experts to take part in the public consultation for the proposed regulation on standards of quality and safety for substances of human origin. To do so, please visit the following page. The deadline to contribute is 8 September 2022.
EC Press Release