What Is the "Marketing Authorisation Document"— Japan's Sho-nin-sho and the Global CTD

Abstract In Japan, the pharmaceutical “Marketing Authorisation Document” (MAD), commonly referred to domestically as the “approval document,” is based on an approval concept that is fundamentally different from the globally adopted Common Technical Document (CTD). As an ICH member country, Japan formally requires CTD-format submissions, giving the appearance of international regulatory harmonisation. However, the actual operation of pharmaceutical approval and lifecycle management in Japan diverges substantially from that of Europe and the United States. This divergence is implicitly evidenced by the absence of a well-established English equivalent for the Japanese approval document.This paper adopts the PMDA translation “Marketing Authorisation Document” and analyses the structural differences between the Japanese approval document and the CTD, demonstrating how the Japanese approval concept is inherently incompatible with globally harmonised GMP and Pharmaceutical Quality Systems (PQS). Furthermore, the paper shows that persistent difficulties in post-approval change management—recurrently observed in Japan’s pharmaceutical supply chain—are rooted in this conceptual discrepancy. Without explicitly articulating these differences, it is not possible to understand why Japan, despite being both an ICH and PIC/S member, has continued to operate a uniquely rigid regulatory system. While GMP and PQS are science-based, risk-based, and inherently dynamic quality systems supported by the CTD as a technical reference, the Japanese approval document functions as a fundamentally static administrative instrument. This paper clarifies this distinction and examines its long-term impact on Japan’s pharmaceutical industry and quality culture.