我国药品注册制度调整对新药研发的影响研究
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篇名: 我国药品注册制度调整对新药研发的影响研究
TITLE:
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 reference for improving the registration success rate of new drug research and development (R&D) enterprises after adjusting drug registration system in China. METHODS: The national drug policies, regulations and related documents were comprehensively studied and combed to explore the main contents of drug registration system adjustment and its effects on the R&D forms, drug patent and on-site verification. The suggestions were put forward. RESULTS & CONCLUSIONS: The adjusted drug management system showed new definitions for new drugs and generic drugs in China, as well as detailed requirements and regulations for drug R&D conditions, process and on-site inspection. It enhanced the protection of patents and patentees. The new drugs should be assessed its market value and clinical advantages. Data contents and requirements for drug registration declaration were made the relevant adjustments. New drug R&D enterprises should develop drug listed license management system as early as possible based on the implementation of listed license management system pilot, improve its efficiency and benefit. The new drug R&D should notice the clinical efficacy and demand of market, focus on the drugs with good clinical efficacy in common diseases, frequently-occurring diseases and major diseases; and those for treating rare diseases, the elderly and children disease can use "easy access" or fast track to accelerate the speed of drug registration. New drug R&D enterprises should improve the R&D conditions, and standardize the management of development process to ensure the effective and smooth development.
期刊: 2017年第28卷第22期
作者: 冯爱玲,郭富利,邢花
AUTHORS: FENG Ailing,GUO Fuli,XING Hua
关键字: 药品注册;制度调整;新药研发;新药研发企业;影响
KEYWORDS: Drug registration; System adjustment; New drug research and development; New drug research and development enterprises; Effect
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