Analysis of GMP for marketing authorization of ATMPs: comparison in the US, the EU, Japan and South Korea.

This study compared regulatory systems of competent authorities related to GMP for marketing authorization of advanced therapy medicinal products (ATMPs). Dossiers for GMP and regulations and guidelines for facilities and equipment were analyzed using gap analysis. The risk-based approach (RBA) and GMP inspection were evaluated with regulations and guidelines. The dossier was similar for the competent authorities. However, whereas a site master file is required in the EU, Japan and South Korea, the US requires only a biologics license application. The regulations and guidelines of facilities and equipment emphasized preventing contamination. There are differences among the competent authorities in GMP inspection and RBAs. Differences among the competent authorities in the marketing authorization process related to GMP for ATMPs should be considered.