Report on the list of Substances of Human Origin (SoHO) preparations based on the survey responses from Competent Authorities: it presents the existing Preparation Processes (PPs), divided per authorised and ongoing.
This flyer outlines the 5-step evaluation for SOHO preparation processes (PPA). It details risk classification and criteria for granting full authorization, conditional authorization, or refusal.
The second newsletter summarizes the results achieved between August 2025 and March 2026: SOHO Regulation implementation, GAPP methodology testing, and cross-country assessments. It serves to keep stakeholders updated
Report on Competent Authorities' training needs for SoHO Preparation Process Authorisation: only 5 countries provide national training due to limited resources; 25 demand regular EU programmes.
The document outlines the update of the EuroGTP II Interactive Assessment Tool, a web platform for assessing the novelty and risks of Substances of Human Origin (SoHO) using a three-step algorithm.
This guide details the EuroGTP II methodology for assessing novelty and risks in substances of human origin, establishing frameworks for validation and clinical follow-up to ensure patient safety.