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Cell-based regenerative medicine: new challenges for EU legislation and governance

Ziel

This proposal aims at collecting and analysing facts and figures in order to assess the current legislation on the therapeutic use of somatic cells, and to bridge it with the research infrastructure capacity building. Although EU has adopted 3 Directives on Tissues and cells between 2004 and 2006 to harmonise the procurement, storage and use of cells for therapeutic use in Europe, countries have implemented these directives in very different ways. Furthermore, research has been partially covered by the initial regulation, calling into question the match between regulation and practices that will develop in the near future, in particular with the emergence of European research infrastructures. Finally many changes have occurred in the scientific, legal and institutional environment of cell use, leading to a necessary update of this regulation with regards to its implementation in national legislation and its impact on research practice and innovation. Two domains are at stake: research (infrastructures) and medical practice/public health measures (cells). The therapeutic use of cells is regulated by EU law whereas its research counterpart is mainly depending on national laws and regulations. This gap calls for a coordinated action in order to optimize the translational process, since the full pipeline is not coherently taken into account in current legislations. To achieve these objectives, our project relies on a coherent consortium of experts in the fields of cells therapies, cells banks and translational biomedicine, having strong expertise in law and/ or in governance issues. After 36 months the project will deliver evidence about the contemporary practices around cells and will design a picture of the “market” and its distribution between the public and private sector. The project will thus help the Commission in the regulatory choices covering the use of human cells for therapeutic purposes and to foster the innovation potential of related research activities.

Wissenschaftliches Gebiet

Programm/Programme

Thema/Themen

Aufforderung zur Vorschlagseinreichung

FP7-HEALTH-2013-INNOVATION-1
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Finanzierungsplan

CSA-SA - Support actions

Koordinator

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
EU-Beitrag
€ 108 739,00
Adresse
RUE DE TOLBIAC 101
75654 Paris
Frankreich

Auf der Karte ansehen
Region
Ile-de-France Ile-de-France Paris
Aktivitätstyp
Research Organisations
Kontakt Verwaltung
Muriel Bouas (Ms.)
Links
Gesamtkosten
Keine Daten

Beteiligte (8)

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Letzte Aktualisierung: 16 Dezember 2021

Mein Booklet

Permalink: https://cordis.europa.eu/project/id/601806/de

European Union, 2024