Ralf D Hess explains the complex regulatory framework that manufacturers need to consider when seeking marketing authorisation of ATMPs in Europe. Enormous scientific progress not only in cellular and molecular biotechnology but also in developmental biology and advanced in vitro methodologies has ultimately led to the production of advanced therapy medicinal products...
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Scrip Regulatory Affairs
Advanced Therapy Medicinal Products in the EU: Navigating the Regulatory Maze
10 March 2010
Francesco Radicati
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