The guide, including its technical Annexes, has been revised to further support the authorisation of preparation processes for blood, tissues and cells. Building on GAPP-PRO pilot activities and contributions from professionals and competent authorities, it now includes new chapters on human milk, faecal microbiota, and blood components for topical or injectable use (e.g. serum eye drops and platelet-rich plasma).
Advances in technology and science continue to contribute to the development of novel Substances of Human Origin (SoHO) and novel preparation protocols/processes for new and existing SoHO.
