我国药品注册制度调整对新药研发的影响研究

发布时间：2018-08-09 07:41

【摘要】：目的:为新药研发企业在我国药品注册制度调整后提高注册成功率提供参考。方法:通过对国家药品政策、法规及相关文献进行全面研究和梳理,了解药品注册制度调整的主要内容及其对药品研发剂型、药品专利、现场核查的影响,并提出建议。结果与结论:我国调整后的药品管理制度对新药、仿制药有了新的定义;对药品的研发条件、研发过程及研发的现场检查均作了具体的要求和规定;加大了对于专利和专利权人的保护。其要求新药应评估市场价值和临床优势;对药品注册申报资料的内容、要求等方面进行了相关调整。新药研发企业应在实施上市许可人管理制度试点的基础上尽早确立药品上市许可人管理制度,提高新药研发企业经营的效率和效益;新药研发应关注临床疗效和市场的需求,应重点关注对常见病、多发病和重大疾病有良好临床疗效的药品,治疗罕见病、老年人和儿童疾病等的药品可利用"绿色通道"或快速审批通道加快药品注册速度;新药研发企业应改善研发条件,规范研发过程的管理,确保研发有效、顺利进行。
[Abstract]:Objective: to provide a reference for new drug R & D enterprises to improve the registration success rate after the adjustment of drug registration system in China. Methods: the main contents of the adjustment of drug registration system and its influence on drug R & D dosage form, drug patent and field inspection were studied and combed through the national drug policy, regulations and related literature, and some suggestions were put forward. Results & conclusion: China's adjusted drug management system has a new definition of new drugs, generic drugs, the conditions of drug research and development, R & D process and field inspection of R & D, and makes specific requirements and regulations. Increased protection of patents and patentees. The market value and clinical advantage of the new drug should be evaluated, and the contents and requirements of the drug registration information should be adjusted. New drug R & D enterprises should establish the drug listing licensor management system as soon as possible on the basis of the pilot implementation of the listing licensor management system to improve the efficiency and effectiveness of the operation of the new drug R & D enterprises, and should pay attention to the clinical efficacy and market demand for new drug research and development. Focus should be placed on drugs that have good clinical effects on common diseases, frequent diseases and major diseases, and drugs that treat rare diseases, diseases of the elderly and children can use the "Green Channel" or fast-track approval channels to speed up drug registration; New drug R & D enterprises should improve the conditions of R & D, standardize the management of R D process, and ensure that R D is effective and smooth.
【作者单位】：沈阳药科大学工商管理学院;
【分类号】：R951

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