2016 - IPITA - Stem Cell Derived Beta Cells Workshop


Road to the clinic and pre-IND studies

13.2 - Stem cell therapy regulatory issues from an EU perspective

Presenter: Giovanni, Migliaccio, Amsterdam, Netherlands
Authors: Giovanni Migliaccio


In Europe, the use of cells for therapeutic purposes suffers from a split personality as three different set of rules are applied by different competent authorities. Overall the members of the European Union recognize that a form of harmonization is needed to favor exchanges across the borders of these products and the establishment of best common practices.
Blood and Blood product are covered by the Directive 2002-98-EC  and its application is demanded to the National Competent Authorities (NCA) through the implementation in national laws.
 Human Cell and Tissue collection and distribution for human use is regulated by the Directive 2004-23-EC and the technical parameters defining the minimal requisite for the Cell and Tissue Centers are defined in the Dir. 2006-17-EC and 2006-86-EC. Again their application is demanded to the NCAs through the implementation in national laws.
The legal framework for medicinal products differs substantially as the  authorization for marketing is centralized and demanded to the European Medicine Agency (EMA), while the manufacturing and development is owned by the NCA. Cell and Tissue as components of a medicinal product are covered by a specific law, the Regulation 1394/2007/EC.
The classification of cellular preparation according to the different rules and the guidelines on their development will be the argument of this presentation.


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