EMA: Scientific guideline: Reflection paper on stem cell-based medicinal products

The aim of this reflection paper is to cover specific aspects related to stem cell-based medicinal products for Marketing Authorisation Application. This reflection paper should be read in conjunction with existing guidance on cell-based medicinal products (Guideline on human cell-based medicinal products (EMEA/CHMP/410869/2006)) which addresses general aspects of cell-based medicinal products. In case of genetic modification of stem cells, the future guideline for genetically modified cells should also be consulted (see Draft guideline on the quality, preclinical and clinical aspects of medicinal products containing genetically modified cells (EMA/CHMP/GTWP/671639/2008)).

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