Abstract

The rapidly growing medical expense going with aging population in Japan requires the use of generic products derived from off-patent active pharmaceutical ingredients (APIs) formulations to reduce the financial burden for the national health insurance system, while at the same time avoiding undermining the quality of medical care. This article provides an overview of the regulatory approaches available to confirm the quality of generic products and gain their greater acceptance by patients. Among several approaches taken by the Ministry of Health, Labor, and Welfare (MHLW), designing systems to supply higher quality products, and providing scientific information to patients and healthcare professionals are key elements to promote the voluntary choice of the generic product. The revision of bioequivalence guidelines and the enhancement of good manufacturing practice (GMP) requirements facilitate the rational development and manufacturing control of generic formulations. A program termed Quality Reevaluation of Ethical Drugs was carried out from 1997 to 2012 using dissolution tests to avoid any significant bioINequivalence between originators and generic oral formulations. The evaluation of product quality and the assessment of the literature information by the Expert Committee on Quality of Generic Drug Products have provided a unique science-based and patient-focused approach for the distribution of reliable generic products. Some current and future issues regarding complex generic drugs are also discussed.