摘要
医院制剂在配合临床用药中功效显著,但由于国家管制标准的提升以及WTO背景下外来药品涌入,医院制剂行业呈现出整体萎靡的态势。以发挥医院制剂功能优势、延续和发展传统中医药文化为目标,应该首先确定医院制剂未来发展的两种模式,即传统的存续性发展模式以及向新药转化的二次研发模式,并在此基础上通过分析现阶段我国医院制剂行业存在的问题,从法律法规的制定与完善、政策性支持、监管体系的建立以及疑难权属关系的梳理等方面,提出摆脱困境的建议和具体设计。
Hospital medicinal preparations have been playing an complementary but important and effective role in clinical practice. None-theless, due to state regulations and introduction of imported drugs under the provisions of WTO, the business of hospital preparations has been, as a whole, shrinking. To bring hospital preparations into full play and take their advantages and to preserve and further develop the traditional Chinese medicine （TCM）, hospitals should develop hospital preparations on a dualistic basis, i.e., the traditional self-sustaining mode and the new-drug research mode （development of new medicines on the basis of traditional preparations）. This study analyzed the problems in the busi- ness of hospital preparations, proposed some suggestions to resolve the problems and specifically designed some feasible solutions or modes from the perspectives of law-making, policy support, establishment of supervising system, and disentanglement of complicated and unclear ownership.
出处
《医学与社会》
2016年第10期79-81,共3页
Medicine and Society
基金
湖北省人民政府2013年度法制研究课题
编号为HBZFFZYJ2013012
关键词
医院制剂
管制
政策法规
Development of Preparations
Control
Regulations and Laws
Research of New Drugs
