审评审批制度改革背景下医药产业组织结构调整路径研究

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英文篇名：Study on the Adjustment Path of Chinese Pharmaceutical Industry's Organizational Structure under the Background of Evaluation and Approval System Reform 作者：王广平 ; 石晟怡 ; 王颖 ; 胡骏 英文作者：Wang Guangping;Shi Shengyi;Wang Ying;Hu Jun;Shanghai Institute for Food and Drug Safety;China Pharmaceutical University; 关键词：审评审批 ; 药品 ; 组织结构 ; 调整 英文关键词：evaluation and approval;;drug;;organizational structure;;adjustment 中文刊名：ZGYS 英文刊名：Chinese Pharmaceutical Affairs 机构：上海市食品药品安全研究中心;中国药科大学; 出版日期：2019-01-20 出版单位：中国药事 年：2019 期：v.33 基金：国家社会科学基金资助项目“我国基本药物供应链的利益平衡与保障体系政策研究”(编号14BG144) 语种：中文; 页：ZGYS201901001 页数：11 CN：01 ISSN：11-2858/R 分类号：9-19

摘要

药品审评审批制度改革,是国务院"放管服""双随机一公开"政策在医药产业研发领域的重大举措。2015年以来,药品审评审批制度改革对中国医药产业组织结构产生了一定影响。基于审评审批制度与政府组织结构、医药组织结构调整的分析,本文采用Panel Data模型对研发创新组织结构相关影响因素进行实证分析。实证分析结果显示了科技孵化器、境内技术转让、技术转移宏观环境对企业临床试验申报行为呈显著性正相关。基于审评审批制度的医药产业组织结构调整路径,包括专业化分工、大数据模式、国际合作、MAH制度和科技金融模式。
        Evaluation and Approval System Reform(EASR) is a major measure of the State Council's "delegate power and optimize service" and "double random and one publicity" policies in the R&D field of the pharmaceutical industry. Since 2015, the EASR has had a certain impact on the organizational structure of China's pharmaceutical industry. Based on the analysis of the evaluation and approval systems, the organizational structure of the government and the structure adjustment of the medical organizations, this paper uses the Panel Data model to analyze the relevant factors affecting the R&D innovation organizational structure empirically. The empirical analysis shows that the technology incubator, domestic technology transfer and macro environment for technology transfer are significantly in positive correlation with the company's clinical trial reporting behavior. Based on EASR, the adjustment to the pharmaceutical industry's organizational structure includes the specialized division, big data mode, international cooperation, MAH system, technology finance mode and so on.

引文

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