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.

中文翻译：

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在日本确认科学质量和改善患者对仿制药产品认知的科学和监管方法

日本随着人口老龄化而迅速增长的医疗费用要求使用源自非专利活性药物成分（API）配方的非专利产品，以减轻国家健康保险系统的财务负担，同时避免损害质量医疗。本文概述了可用于确认仿制药质量并获得患者更大接受的监管方法。在厚生劳动省（MHLW）采取的几种方法中，设计系统以提供更高质量的产品，并向患者和医疗保健专业人员提供科学信息是促进自愿选择仿制产品的关键要素。生物等效性指南的修订和良好生产规范（GMP）要求的提高促进了通用制剂的合理开发和生产控制。从1997年至2012年，开展了一项名为“伦理药物质量重新评估”的计划，该计划使用了溶出度试验，避免了始发者与通用口服制剂之间存在重大的生物等效性。通用药物产品质量专家委员会对产品质量的评估和文献信息的评估，为可靠的通用药物的销售提供了一种独特的，以科学为基础，以患者为中心的方法。还讨论了有关复杂仿制药的一些当前和将来的问题。