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Regulatory and technical standards for novel applications

ESHRE Contributor and position at the time:

Cristina Magli, Italy, ESHRE Chair
facilitatinG the Authorisation of Preparation Process for blood and tissues and cells (GAPP)

This project dealt with a review of regulatory and technical standards for innovation in the field of blood, tissue and cell products. GAPP built on the EuroGTP II and VISTART projects and established bridges with the tools developed by professionals in the EuroGTP II project.

The project aimed at facilitating the development of a common and optimal approach to assess and authorise preparation processes in blood and tissue establishments with particular attention devoted to innovative processes that might come up, taking advantage of the work developed in previous EU funded projects/actions. The final aim was to increase harmonisation of those Member State (MS) activities that regulate the areas of blood transfusion and transplantation of tissues and cells and ART.

Special attention was given to the field of ART that involves a considerable amount of movement of both donated substances of human origin and citizens between MS. The Joint Action has developed “Good Practice Guidelines to authorisation on preparation processes in blood, tissues and cells establishments” with three technical annexes respectively on i) authorisation of changes in donation, procurement and collection, processing, preservation, storage and distribution (divided in four parts, namely blood, haematopoietic progenitor/stem cells, medically assisted reproduction, and other tissues and cells); ii) assessing the quality and safety of donor testing, pathogen reduction and sterilisation steps as part of preparation process authorisation; iii) assessing clinical data as part of preparation process authorisation. Finally, a tool was built to facilitate sharing of information among EU Competent Authorities (CAs), and a number of CA inspectors were trained specifically to assess and authorise preparation processes of tissues, cells, reproductive cells and blood products.