The GAPP-PRO Consortium is pleased to announce the approval of two key deliverables of Work Package 8 (WP8), supporting the update and extension of the EUROGTP II framework for the assessment of Substances of Human Origin (SoHO) in Europe.
- D8.1 – Update of the EUROGTP II Risk Assessment Guide
The guideline, including its technical Annexes, has been updated to support the authorisation of preparation processes in blood, tissues and cells, building on the results of the GAPP Joint Action pilot tests and on the contributions of professionals and competent authorities involved.
The update includes new chapters covering human milk, faecal microbiota, blood components for topical use or injection (serum eye drops and platelet-rich plasma from both peripheral and umbilical blood), further strengthening the methodological framework for the assessment of the safety, quality and effectiveness of SoHO preparation processes.
- D8.2 – Update of the EUROGTP II Interactive Assessment Tool (IAT)
The EUROGTP II platform has been enhanced and extended to additional SoHO, providing European professionals with the opportunity to perform structured, harmonised and risk-based assessments across a broader range of products.
The updated Interactive Assessment Tool (https://tool.goodtissuepractices.site/staging/indexS.html) supports users through a stepwise approach, enabling them to:
- determine whether a SoHO preparation or process presents any novelty;
- assess the associated risks;
- define the extent of required studies and/or follow-up.
The tool is designed to assist SoHO Entities, SoHO Establishments and healthcare professionals in the evaluation of the safety, quality and effectiveness of SoHO and SoHO-based therapies, ultimately contributing to safe and effective patient care.
Both deliverables represent a key step towards the implementation of a harmonised, evidence-informed and risk-based European framework for the assessment and authorisation of new SoHO preparation processes, supporting preparedness for the evolving EU SoHO regulatory landscape.
This tool has been developed within the GAPP-PRO Joint Action, based on the methodologies defined by the prior European Project EuroGTP II and it is accessible at the following link:
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