During the 9th Microbiome Movement Summit Europe, held recently in Barcelona (Spain) Microbiomepost sat down with Celine Druart, from the Pharmabiotic Research Institute.

In this interview, Druart discusses the new European regulation concerning substances of human origin and the impact on microbiome research and therapeutic development, particularly regarding the collection and use of human-derived samples. 

While the regulation was published in 2023, it will become fully applicable in 2027, giving companies a three-year transition period to ensure compliance.

The regulation will affect procedures involving human microbiota, such as fecal and vaginal microbiota transplants, and also extend to the manufacturing of regulated products like pharmaceuticals, medical devices, and advanced therapy medicinal products (ATMPs). Although current products in development are not yet impacted, companies will need to prepare for changes in collection, processing, and documentation standards.

As of now, only the main regulation has been released, with delegated and implementing acts still pending. Stakeholders are eagerly awaiting these details to better anticipate the scope of necessary adjustments and ensure readiness for the 2027 enforcement deadline.