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...

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Bibliographic Details
Published in:Regenerative medicine 2022-05, Vol.17 (5), p.283-297
Main Authors: Shin, Hocheol, Kim, Eunyoung
Format: Article
Language:English
Subjects:
advanced therapy medicinal products
ATMPs
European Union
gap analysis
GMP
good manufacturing practice
Japan
Marketing
marketing authorization
regulation
regulatory system
Republic of Korea
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Summary: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.
ISSN:1746-0751
1746-076X
DOI:10.2217/rme-2021-0153