EMA: Scientific guideline: Reflection paper on stem cell-based medicinal products
07.02.2011
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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