对现行的中药注册分类制度改革的建议和思考

中药注册分类制度经过多年的发展逐步完善,但仍存在一些明显的弊端,以药物成分含量高低决定中药新药的层次分类给中医药行业发展带来了隐患。分析现行的中药注册分类制度存在的不足,探索新的中药注册管理制度。建议取消中药新药等级分类,建立以满足临床需求为评价标准和模式的管理方式,是未来中药新药注册管理方向。

Suggestion and thinking on reformation of current classification system for Chinese materia medica registration

To analyze the shortage of current classification system of Chinese materia medica (CMM) registration and discuss a new one. Even though the current classification system has been perfected during these years' development, there are still some obvious shortcomings. This classification based on the levels of drug ingredient content has brought some disadvantages and hidden dangers to the development of CMM. The idea of CMM registration classification and a method established to meet the clinical needs is the future direction in CMM registration management.