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Advanced therapy medicinal products (ATMPs) comprise gene therapy medicinal products (GTMPs), somatic cell therapy medicinal products (CTMPs), and tissue-engineered products (TEPs). So-called combined ATMPs incorporate one or more medical devices as an integral part of the product. Because of their complexity and innovative nature, ATMPs pose new scientific and regulatory challenges to both developers and regulators.1 Many developers of such products request scientific advice from the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA).
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Vestergaard et al. (2013) studied this question.
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