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我国药品上市许可持有人制度下的区域协作监管机制的完善(5)
http://www.100md.com 2020年8月1日 《中国药房》 202015
     [15] 王晨光.药品上市许可持有人制度:我国药品注册制度改革的突破口[J].中国食品药品监管,2016,14(7):21-24.

    [16] 白庚亮,姚松梅,杨勇.江苏省药品上市许可持有人制度试点现状分析及政策建议[J].中国新药杂志,2019,28(22):2687-2692.

    [17] Australian Government Department of Health Therapeutic Goods Administration. Australian register of therapeutic goods[EB/OL].(2019-10-29)[2020-05-04].https://www. tga.gov.au/australian-register-therapeutic-goods.

    [18] European Medicines Agency. Compilation of community procedures on inspections and exchange of information[EB/OL].(2014-10-03)[2020-03-02].http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_ procedural_guideline/2009/10/WC500004706.pdf.

    [19] FDA. Facts:centers of excellence in regulatory science and innovation (CERSI)[EB/OL].(2018-06-09)[2020- 03-02].https://www.fda.gov/science-research/advancing- regulatory-science/centers-excellence-regulatory-science- and-innovation-cersis.

    [20] 國家药品监督管理局.药品上市许可持有人数据库上线[EB/OL].(2019-08-02)[2020-03-02].http://www.nmpa.gov.cn/WS04/CL2168/339693.html.

    (收稿日期:2020-03-09 修回日期:2020-05-27)

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