Navigating Japan’s New OTC Drug Classifications – Global Lessons for U.S./EU Markets

Abstract

In September 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) reclassified two widely used OTC ingredients—oxymetazoline and chlorpheniramine—from Class I (high risk) to Class II (moderate risk), marking a significant shift in Japan’s pharmaceutical landscape. This change, rooted in post-market safety data and aligned with global regulatory harmonization, eases point-of-sale restrictions but heightens compliance responsibilities for manufacturers, distributors, and pharmacies. The reform underscores Japan’s alignment with international OTC safety trends, emphasizing proactive risk management, consumer education, and standardized labeling.

For global pharma and consumer health players, this reclassification exemplifies the accelerating convergence of OTC regulation across Japan, the U.S., and the EU—each advancing toward more data-driven, risk-based oversight. Within this evolving environment, Regulatory Intelligence (RI) has emerged as a critical enabler of readiness. RI systems support real-time tracking of reclassifications, automate labeling and documentation updates, and synchronize compliance efforts across markets.

This whitepaper explores how RI transforms regulatory adaptation from reactive to predictive—empowering organizations to anticipate policy shifts, streamline global compliance, and maintain market confidence amid an increasingly dynamic OTC governance framework.