Piloting GAPP model approach for assessing and authorizing novel substances of human origin preparation PROcess.

GAPP-PRO is a Joint Action co-funded by the Heath Programme of the European Union (Grant Agreement 101128035 – EU4H-2022-JA-07, February 2024 – June 2027). It stands as proceedings of the previous European initiative GAPP and brings together national Competent Authorities (CAs) and other stakeholders involved in the field of preparation process authorization.

GAP-PRO Joint Action (JA) aims at testing and perfecting the previous GAPP JA (GA 785269) methodology, through the following actions, whilst ensuring EU wide adoptions of guidelines, findings and legacy:

-piloting of authorization processes for different substances of human origin (eg: fecal microbiota, breast milk, platelet lysate eye drops), including bedside preparations;

-verifying the capability to implement the GAPP model in the different Member States (MSs), with special reference to a common assessment of risk levels;

-testing the methodology in a perspective of multi-country assessment;

-testing the feasibility of joint assessments, including – whenever necessary – interactions with stakeholders from the fields of medical devices and pharmaceutical;

-updating the EuroGTPII risk assessment tool extending the already available platform to other SoHOs (namely fecal microbiota and breast milk). Eventually, the Good Practice Guideline to authorization on preparation process in blood, tissues and cells establishments, developed in GAPP will be updated, taking advantage of the results of the pilot tests as well as the opinions of the different professional and competent authorities that took part in the pilot tests.

GAPP-PRO

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