2025 Volume 15 Issue 3 Pages 183-194
The Japan Pharmaceutical Manufacturers Association’s Regulatory Affairs Committee has reported on the differences between Japan, the United States, and Europe with regard to the description of quality-related approval document, categories of approval item change procedures and review periods, and the operation of GMP investigations. Since discussions have started in Japan toward the realization of a risk-based change management system for international harmonization, we report on the current understanding of “risk-based change management” as the third survey.