Description Over the past decade, Japan has experienced a persistent pattern of GMP violations, quality failures, and pharmaceutical supply disruptions. These events are often framed as isolated incidents of misconduct or compliance failure. This article challenges that interpretation and argues that the root cause lies in the structural design of Japan’s GMP framework itself. Through qualitative analysis of regulatory laws, inspection guidelines, PMDA Orange Letters, and publicly available inspection reports, this study demonstrates how Japan’s GMP has evolved into a system centered on formal document conformity rather than scientific judgment and risk-based decision-making. In particular, it reveals how accountability for product quality is fragmented among regulatory authorities, marketing authorization holders (MAHs), and manufacturing sites—without being effectively anchored to any single actor. The analysis shows that this fragmentation undermines the functioning of pharmaceutical quality systems (PQS), weakens change management, suppresses regulatory learning, and shifts patient risk management away from system-level oversight toward individual practitioners’ ethical judgment. Repeated violations are therefore not anomalies, but predictable outcomes of a system that consumes individual integrity to compensate for structural deficiencies. Rather than proposing idealized regulatory reform, the article focuses on practically achievable interventions within the current framework. It emphasizes the central role of MAHs in re-anchoring accountability and proposes the establishment of a Responsibility Allocation Map as a concrete mechanism to restore system-level responsibility and feedback loops. This article is intended for regulators, quality professionals, industry leaders, and researchers engaged in GMP, PQS, and regulatory science, offering a structural perspective on how scientific integrity can erode within formally compliant systems—and how it may be restored.
Practitioner GMP (Sun,) studied this question.