Recent recalls of many generic drugs caused by violations of Good Manufacturing Practice (GMP) rules have caused a severe shortage of the products and associated substantial impact on the medical care system. This mini review introduces the 15-year activities of the Expert Committee on Quality of Generic Drug Products (ECQGDP), which was established to discuss issues related to the quality of generic drugs by the Ministry of Health, Labour and Welfare. The ECQGDP coordinates an annual speci cation test program of generic drugs performed by of cial medicines control laboratories. In addition, the ECQGDP performs comparative dissolution tests using four dissolution media at different pHs to avoid signi cant non-bioequivalence between products, and impurity analysis of injection formulations of brand and generic products. Some properties of formulations that are not listed in their speci cations (eg, adhesion durability of patch formulations) were also discussed to avoid their signi cant difference in usability between the products. The committee also assesses issues of generic drugs reported in literatures, academic conferences, and inquiry calls to the PMDA. Discussions at the ECQGDP have led to improvements in many products. The improved collaboration of the quality testing and GMP inspections should signi cantly reduce compliance issues in pharmaceutical manufacturing.