GRS Blog

Stem Cell Therapy Regulations: The US vs the EU (peer reviewed article)

15/5/2011

 In the US, products derived from stem cells are regulated as biologics, and are deemed to be a subclass of somatic cellular therapies.  

Scientific advice regarding these products is provided by the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC), under the auspices of the FDA’s Office of Cellular, Tissue and Gene Therapies (OCTGT).  To receive federal funding, sponsors must apply to the National Institutes of Health, although individual US states may offer private funding for such research. 

Meanwhile, stem cell therapy in the EU comes under the Advanced Therapy Medicinal Products (ATMP) regulatory framework, aimed at making these therapies accessible to patients across the EU, while at the same time ensuring a high level of health protection for such patients. 

Under this regulation the Committee on Advanced Therapies (CAT) has been established, with members specialising in the field of ATMPs.  This committee assesses the quality, safety and efficacy of ATMPs, and drafts opinions on ATMP applications submitted to the European regulatory agency, the EMEA, to be considered by its Committee for Medicinal Products for Human Use (CHMP).  

The purpose of this article is to explore and compare the regulations surrounding stem cell therapy (including human Embryonic Stem Cell (hESC) therapy) in both the US and the EU.

Author: Greer Deal, Director of Global Regulatory Services