The main objective of this project is to set up the good practices applied to tissues and cells (T&C) preparation processes and patient follow-up procedures, to ensure their safe and effective implementation.
The outputs of this project will provide tools for assessing and verifying the quality, promote safety and assure efficacy of therapies with human tissues, Hematopoietic Stem Cells (HSC) and Assisted Reproductive Technologies (ART), addressing mainly to the implementation of novel T&C preparation processes and clinical indications, but also to the need of retrospective studies where weaknesses or insufficient safety data currently exist.
Recommendations will be forwarded to Tissue Establishments (TE) and Organizations Responsible for Human Application (ORHA), as the main actors in the process of validation and designing T&C preparation processes and patient follow-up according to a clinical indication.
This project aim to define the threshold of novelty, including definition of the factors that should be considered to determine the scope and depth of the clinical follow-up studies needed. The scope and extent of the recommended studies will be determined on the basis of a risk based approach performed taking into account factors such as the novelty of the product/preparation process/clinical indication, and its technical complexity.
A T&C Database of products, preparation procedures, clinical applications and their current status of authorisation and implementation will be established, working as a starting point for determining the ‘novelty’ of processes/therapies by TEs and ORHAs, and allowing the use of established processes/therapies by any centre that strictly follows the same procedure/clinical procedure/indication.
This project also aims to define a “GTP’s management model” that could provide impetus for future standards harmonisation and promotion, and allow the establishment of European accreditation and training programs for TE.


GAPP Joint Action (facilitatinG the Authorisation of Preparation Process for blood and tissues and cells) is a 36 months JA aiming at facilitating the development of a common and optimal approach to assess and authorise preparation processes in blood and tissues establishments (BEs and TEs). Particular attention will be devoted to innovative processes that might come up taking advantage of the work developed in previous EU funded projects/actions. This Joint Action will clearly contribute to the implementation of Union legislation in the fields of human tissues and cells, blood, providing tools and training to increase harmonisation of those MS activities that regulate the areas of blood transfusion, transplantation of tissues and cells and assisted reproduction, in strong abidance with art 4.5 of Annex I of Regulation 282/2014. These are fields of healthcare that involve a considerable amount of movement of donated substances of human origin between MS and also movement of citizens between MS for treatment, particularly in the field of assisted reproduction. The aim of the action is to prepare a “Good Practice Guidelines to authorisation and preparation process in blood, tissues and cells” and its three technical annexes respectively on i) authorisation changes in donation, procurement and collection, processing, preservation, storage and distribution (divided in three part blood, tissues and cells, and reproductive tissues and cells); ii) assessing the quality and safety of donor testing, microbial inactivation and sterilisation steps as part of PPA; iii) assessing clinical data as part of PPA. In addition to this it will be built a model and a tool to facilitate sharing of information among European Union Competent Authorities and a number of CA inspectors will be trained specifically to assess and authorise preparation processes of tissues, cells, reproductive cells and blood products.


Over five million patients in the EU annually receive transfusions or transplantations of substances of human origin (SoHO): blood components, plasma derived medicines, tissues & (stem) cells, germ cells for assisted reproductive technologies and organs. These treatments depend heavily on the availability of SoHO obtained from more than 13 million donors. Obviously, donor availability is the most vulnerable link in assuring these treatments.

Procedures to collect SoHO, including donor selection and the actual collection or procurement, are regulated in the EU by several directives. In addition, the European Directorate for the Quality of Medicines & Health Care (EDQM) publishes recommendations (Guides) relating to the preparation, use and quality assurance of SoHO forming a basis for standard operating procedures. From this, one could infer that practice throughout Europe is harmonised. However, implementation of the directives and Guides in Member states has resulted in diverging donor selection and protection policies. Expert opinions, lacking quantitative risk-based selection criteria, and prompting a one-size-fits-all approach, have in fact lead to inflexibility and inconsistency.

TRANSPOSE aims at a structured, alternative approach to construct risk-based Guidelines for the selection and protection of donors. To this end, TRANSPOSE will involve a massive pool of experts and take stock of current practices and scientific insights.

TRANSPOSE may facilitate the process of revising related EU Directives. Moreover, the developed guiding principles and Donor Selection & Protection Guidelines will assist EU member states to implement policies in a consistent and clear-cut way. Finally, a standard Donor Health Questionnaire with carefully guided local/regional/national customization will become available, which can be used widely and will enable comparisons between Member States on the prevalence of certain risks and risky behaviours throughout Europe.

