The European Joint Action Project known as GAPP PRO (Piloting GAPP model approach for assessing and authorising novel substances of human origin preparation PROcesses) is a European initiative co-funded by the European Commission within the EU4Health Programme. 

During its lifetime (from February 15th 2024 to June 14th 2027), this project aims at testing and perfecting GAPP JA (GA 785269) methodology for both regulators and stakeholders. 

This activity will assist with the harmonisation of authorisation procedures across EU Member States and implementation of the new substance of human origin (SoHO) Regulation.

A key strength of the GAPP-PRO initiative is the collaboration among its members. The HPRA will participate in work package 8 to refine the GAPP guideline on authorisation of preparation process in blood, tissues and cells. 

Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or HADEA. Neither the European Union nor the granting authority can be held responsible.