GAPP PRO (Piloting GAPP model approach for assessing and authorising novel substances of human origin preparation PROcesses) is a European health initiative. It is co-funded by the European Commission under the EU4Health Programme. 

GAPP PRO aims to support the harmonisation of authorisation procedures across all EU Member States. It also aims to help implement the new EU SoHO Regulation making the process more consistent and efficient across Europe.

The project was launched in February 2024 and will run until 14 June 2027.

What is the objective of GAPP PRO?

The main goal is to test and improve the  GAPP Joint Action (GA 785269) method. This method helps regulators and stakeholders assess and authorise new processes involving substances of human origin (SoHO), such as blood, tissues and cells.

HPRA colleagues are participating in Work Package 8 of the project. This package focuses on refining the GAPP guidelines for authorising preparation processes in blood, tissues and cells. 

Where can I learn more?

Visit the GAPP PRO website to learn more about the project, download resources, and key updates.

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.