医疗机构中药制剂向中药新药转化探析.docVIP

医疗机构中药制剂向中药新药转化探析[摘要] 笔者分析了医疗机构制剂在新药开发中的优势，指出医疗机构中药制剂研发中存在临床评价不规范、医疗机构自身新药开发能力较低、缺少良好的合作研发平台及知识产权保护问题等问题。针对上述问题，笔者提出三点建议：一是规范临床研究，建立信息数据库；二是医疗机构、科研机构和药品生产企业联合创建良好的新药研发平台；三是加强知识产权及研究者利益的保护。全文为医疗结构在新的药品注册法规体系下，促进医疗机构中药制剂向新药转化提供一些思路。 [关键词] 医院制剂；中药制剂；药品注册；医疗机构 [中图分类号] R283.6 [文献标识码] A [文章编号] 1673-7210（2012）07（b）-0005-03 Inquiry on TCM preparation transforming to new TCM drugs in medical institutions CHEN Peiyi1 WU Shengqi1 TANG Nianzhong1 ZHOU Weijun1 SUN Dongmei2 1.Certification Center of Food and Drug Supervision and Administration Bureau, Guangdong Province, Guangzhou 510080, China; 2.Chinese Medicine Research Institute of Guangdong, Guangdong Province, Guangzhou 510095, China [Abstract] The authors analyzed the advantages of the medical institutions preparation in the development of new drugs, pointed out that medical institutions had problems of non-standard clinical evaluation, low drug development capabilities, lacking good cooperation in research and development platform and intellectual property protection. In response to these problems, the authors put forward three suggestions: 1.standardizing clinical research and establishing an information database; 2.medical institutions, research institutions and pharmaceutical manufacturing companies combined to establishing a good drug discovery platform together; 3.the intellectual property rights and researcher interests should be protected. The whole text provided some ideas that can promote TCM preparation in medical institutions to convert to new drugs in the new drug registration and regulation system. [Key words] Medical preparation; TCM preparation; Drug registration; Medical institutions、 医疗机构中药制剂是医疗机构根据本单位临床需要经批准而配制、自用的固定的中药处方制剂。长期以来，医疗机构中药制剂在满足临床需求、促进中医药事业发展方面发挥了重要作用，但是，也存在发展不平衡、与中医临床需求结合不够、优势和特色体现不突出等问题。随着新修订的《药品注册管理办法》（局令28号）的颁布实施，国家食品药品监管局通过整合药品注册管理资源，深化药品注册审评机制改革，严格药品注册审批程序，建立高效运转、科学合理的药品注册管理体制，使我国药品注册工作体系逐渐完善，日趋科学严谨，自2007年10月1日新修订的《药品注册管理办法》实施以来，我国药品注册申报数量大幅减少、申报质量不断提高、申报机构更加趋于理性，药品研发呈现新