The Harmonize project, co-funded by the European Union, is dedicated to support the implementation of the new substances of human origin (SoHO) regulation by the development of expert groups, training program and guidelines that secure the preparation, distribution and application of safe and effective Faecal Microbiota Transplantation (FMT) preparations in the European Union (EU).
The project is based on the sub-objectives listed below.
1) Expert forum:
• Create a pool of FMT experts from different entities
2) Guideline development:
• Guidelines on processing standards for FMT
• Guidelines to comply with oversight requirements
• An approach for the future update of theses guidelines
3) Training program:
• Development and implementation of training programs for stool banks
4) Gap analysis in FMT-related procedures
• Harmonizing data from different EurFMT partners in the EurFMT registry
5) Facilitate a dialogue with industry stakeholders and regulators
Read more about the Harmonize project on eurfmt.com
