Piloting GAPP model approach for assessing and authorizing novel substances of human origin preparation PROcess (GAPP PRO)

Agence de la biomédecine is taking part in the European GAPP PRO project, part of the EU 4 Health program funded by the European Union. Coordinated by Italy, the project's aim is to test assessment and authorization tools for new blood, tissue and cell preparation processes. This European project aims to identify potential difficulties in implementing these new preparation processes in the various member states, and to harmonize the method for assessing new preparation processes on a European scale. GAPP PRO brings together 13 European countries and 1 non-European country, and will run for 40 months, starting in February 2024. In practice, in order to test and perfect the GAPP methodology, what activities will be carried out?

• Pilot authorization processes for various substances of human origin;
• Assessing the capacity of member states to implement the GAPP model, with a particular focus on harmonized assessment of risk levels;
• Test the methodology from a multi-country assessment perspective;
• Experiment with the feasibility of joint assessments, including, where appropriate, in conjunction with stakeholders from the medical device and pharmaceutical sectors.

The common aim of all these actions is to update the GAPP guide to good practice for the authorization of the preparation process in blood, tissue and cell establishments, taking into account the results of the pilot tests and the opinions of the various professional and competent authorities.

• an expert role: the Agence de la biomédecine is making available its medical experts in its fields of competence.
• a project management role: Agence de la biomédecine is responsible for two work packages within the framework of this project. Project managers are responsible for coordinating these activities and organizing the associated working groups. They are also in charge of administrative and financial management, and ensure that deliverables are delivered on time.