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

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 using gap analysis. The risk-based approach (RBA) and GMP inspection were evaluated with regulations and guidelines. Results: 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. Conclusion: Differences among the competent authorities in the marketing authorization process related to GMP for ATMPs should be considered.