日本汉方药源于中医药，但在长期的历史发展过程中，逐渐形成了具有日本特色的汉方药文化，并建立了完善的汉方药生产质量管理规范及注册管理制度，形成了有别于我国中成药发展的汉方药研究开发模式及质量控制管理体系，在很多方面与我国中成药目前的现状是有差异的，特别是在质量管理方面的很多经验值得学习和借鉴。

Chinese prescription medicine in Japan derives from China's traditional Chinese medicine. Yet during the long histroy of development, the management system of production, quality standard, and registration have been gradually establised in Japan. Research and development pattern and quality control management system for Chinese prescription medicine are formed and are different from those in China. Many of them are different with our current situation, especially in the aspect of quality management. Thus their experience is worth learning and using for reference.