The GAPP PRO JOINT ACTION
Overview
The GAPP-PRO Joint Action 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.
In the last years, a significant progress has been made impacting the field of Substance of Human Origin (SoHO): new methods of testing for viruses to ensure safe donations, new scientific evidence on donor selection/deferral criteria, new genetic testing for extensive screening of gamete donors; innovative methods of processing blood, tissues and cells (e.g. pathogen reduction strategies); new categories of patients/donors due to new clinical practices. Moreover, the epidemiological situation has changed worldwide given to the increased global circulation of citizens favouring the spread of viruses.
In this context, the rapid growth of innovative therapies based on SoHO involves several medical and surgical fields, dealing with increasing therapeutic opportunities for patients in Europe. The several applications of platelet components, mainly in the autologous and bedside setting (e.g. platelet concentrated, lysate), as well as cellular components (adipose tissue, bone-marrow-derived cells, decellularised cardiac tissue, skin tissue and combined use of tissues with medical devices) and other SoHO as faecal microbiota, represent an example of a quite spread SoHO therapy, thanks to the continuous development of new medical devices. Additionally, some SoHO preparations already authorised by Competent Authorities are used for different clinical indications, without a specific risk analysis.
The lack of standard specifications of the products/preparation processes and the lack of a common approach for the authorisation procedures may have an impact on the quality, safety and accessibility of the therapies for patients. Hence, there is a high need to promote harmonisation of the authorisation procedures and of the evaluation risk, which are still very different among Member States (MSs).
Objectives
The Joint Action (JA) aims at testing and perfecting GAPP JA (GA 785269) methodology, through the following actions, whilst ensuring EU wide adoptions of guidelines, findings and JA legacy:
- piloting of authorization processes for different substances of human origin (eg: faecal 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 EuroGTP II risk assessment tool extending the already available platform to other SoHOs (namely fecal microbiota and breast milk);
- refining the Good Practice Guideline to authorization on preparation process in blood, tissues and cells establishments, developed in previous GAPP JA, taking advantage of the results of the pilot tests as well as the opinions of the different professionals and competent authorities that took part in the pilot tests.
