Analysis of GMP for marketing authorization of ATMPs: comparison in the US, the EU, Japan and South Korea.
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DOI: 10.2217/rme-2021-0153
Abstract: Aim: This study compared regulatory systems of competent authorities related to GMP for marketing authorization of advanced therapy medicinal products (ATMPs). Methods: Dossiers for GMP and regulations and guidelines for facilities and equipment were analyzed… read more here.
Keywords: gmp marketing; authorization; japan south; south korea ... See more keywords