Call: Common assessment methodology on quality, safety and efficacy of transplantation therapies

The EU is required by its founding treaty to ensure that human health is protected as part of all its policies, and to work with the EU countries to improve public health, prevent human illness and eliminate sources of danger to physical and mental health. The 3rd Health Programme has 4 overarching objectives:

1. Promote health, prevent diseases and foster supportive environments for healthy lifestyles taking into account the 'health in all policies' principle,
2. Protect Union citizens from serious cross-border health threats,
3. Contribute to innovative, efficient and sustainable health systems,
4. Facilitate access to better and safer healthcare for Union citizens.

This action aims to build a common assessment methodology to allow academics, health professionals and authorities to assess and verify safety, quality and efficacy of (new) transplantation therapies and/or other type of clinical applications of human tissues and cells (e.g. assisted reproductive technologies). An increasing number of discussions in the area of substances of human origin (SoHO), especially in the tissue and cell transplantation sector showed that there is an acute need to improve the common understanding of safety, quality and efficacy issues. These relate not only to processes and techniques for the preparation of tissues and cells, but also to their clinical application. In addition to the safety of the donated material, appropriate methodologies/tools for establishing the relation between the quality of tissues/cells and the efficacy of a specific application are needed. This improved and shared understanding is important for an optimal use of a limited resource such as human tissues and cells. Therefore, in the context of a fast-paced technological progress, developing appropriate methodologies/tools for ensuring high quality, safety and efficacy standards for the tissues and cells for clinical application is of utmost importance.

Applicants participating in a project proposal have to be different legal entities (i.e. independent from each other) from at least 3 countries participating in the Health Programme.