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| 引用本文： | ����,������,������,��. ����ҩƷ��������ҩƷ��������ƶ�����о�[J]. 中国药学杂志, 2015, 50(17): 1558-1562. DOI: 10.11669/cpj.2015.17.022 |
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| 作者姓名： | ���� ������ ������ �� |
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| 作者单位： | ??????????????????, ???? 110016 |
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| 摘 要： |
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| 关 键 词： | ?? ??????? ?????? ????????? ???????????? |
Research on Drug Marketing Authorization System Design Based on Revision of the Drug Administration Law |
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| YANG Yue,Li Xiao-yu,Liu Jing-jie,Ren Yu. Research on Drug Marketing Authorization System Design Based on Revision of the Drug Administration Law[J]. Chinese Pharmaceutical Journal, 2015, 50(17): 1558-1562. DOI: 10.11669/cpj.2015.17.022 |
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| Authors: | YANG Yue Li Xiao-yu Liu Jing-jie Ren Yu |
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| Affiliation: | School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016,China |
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| Abstract: | ??OBJECTIVE To put forward some suggestions on drug marketing authorization system design for the revision of Drug Administration Law. METHODS Compared the difference for drug marketing authorization system design of China, the US and EU, analyzed the advantage of the marketing authorization system of the US and EU; RESULTS AND CONCLUSION Presented 4 key elements for drug marketing authorization system, put forward that to allow applicant and applicant holder change, remove the binding between marketing authorization and manufacturer, strengthen responsibilities and obligations for applicant and applicant holder??s safety and efficiency assurance during the entire life cycle of the drug, and for manufacturers and distributors?? quality assurance and implementing supply chain traceability. |
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