关于含国家重点保护野生药材中成药注册申请的思考

对我国重点保护野生药材的相关法律法规、重点保护野生药材的资源和应用现状进行了简要回顾,并对我国重点保护野生药材管理及应用中存在的问题进行了初步分析.建议以源自国家重点保护野生动植物的药材为原料进行的中成药注册申请,应根据药材的濒危等级、药材资源及与应用需求的情况,制订相应技术要求,并加强管理,以促进野生药材资源的可持续利用.

Pondering on registration of Chinese patent medicine containing national key-protected wild medicinal materials

Some laws about the national key-protected wild medicinal materials, their resources and application status are reviewed. Some problems about the management and application of the national key-protected wild medicinal materials are also analyzed. It is suggested that the special technical requirements should be put forward according to the endangered categories, the state, and requirement of resource. The registration of Chinese patent medicine containing the national key-protected wild medicinal materials should be confined strictly for their sustainable utilization.