日本蓝皮书

仿制药质量再评价工作在日本开展了近20年，淘汰了约10%的不合格药品。对于仿制药质量再评价的跟踪和实施、市场抽验及药品质量研讨会有效保证了口服固体仿制药药品质量的一致性和有效性，日本蓝皮书已经对该项工作成果的集中系统整理，对我国开展仿制药一致性评价工作具有积极的启示。建立的日本蓝皮书数据库在丰富现有数据库的同时，也给用户提供了一个便捷的查询方式。

The generic drug quality re-evaluation initiative has been implemented in Japan for nearly 20 years, eliminating approximately 10% of substandard drugs. The tracking, implementation, market sampling inspection, and drug quality seminars associated with this re-evaluation program have effectively guaranteed the consistency and efficacy of oral solid generic pharmaceuticals. The Japanese Blue Book has systematically and centrally organized the outcomes of this initiative, offering positive implications for China's generic drug consistency evaluation work. The established Japanese Blue Book database enriches existing database resources while providing users with a convenient query approach.