Substances of Human Origin
A project for: DG SANTE & HaDEA
BRIEF
The Challenge
In 2024, the Regulation (EU) 2024/1938 on standards of quality and safety of substances of human origin (SoHO) intended for human application was adopted, with its transitional period set to conclude by August 2027. The scope of the new SoHO Regulation encompasses blood, tissues, cells, and other substances such as breast milk and intestinal microbiota. It introduces significant changes to ensure the safety, quality, and availability of SoHO while fostering innovation and enhancing cooperation across Member States.
This study aims to improve coherence and regulatory efficiency for SoHO-based therapies that are falling under multiple legislative frameworks and to facilitate understanding and cooperation among the various authorities involved. The relevant regulatory frameworks include those governing medical devices, medicinal products and ATMPs.
FOCUS
The Approach
First, desk research, exploratory interviews and an online survey will be conducted to obtain a better understanding of the topics to be addressed during the study. In addition, an online stakeholders’ meeting will be held to inform stakeholders about the study and get first insights into the key topics.
In the subsequent phase of the study, six stakeholder meetings are scheduled. Two of these will serve as preparatory sessions to validate findings from earlier activities and confirm the principal topics for discussion. The remaining four meetings will focus on these topics and aim to develop strategies and approaches to support coordination and communication for information exchange across relevant authorities.
CONCLUSIONS
The Envisioned Result
The strategies and approaches resulting from the four topic-specific stakeholder meetings will be consolidated in the final report, aiming to enhance the interplay between SoHOP-derived therapies and medicinal products/devices and their respective authorities.
PREDICTBY
Our Role
PredictBy is leading the research activities for this tasks in this project as experts in project management, desk research and stakeholder consultation activities.
Our role in the project consists of conducting the following tasks:
Desk research
Exploratory interviews
Online survey
Organising online, hybrid and in-person stakeholder meetings