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The Drug Marketing Authorization Holder Mechanism: Moving Forward through Exploration

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作者/编者: Huang Jianwen 作者单位: 金杜律师事务所
学科分类: 经济法学 类型分类: 综合
创作年代: 2016 所属机构: 金杜律师事务所
出处/来源: 金杜律师事务所 文献语种: 英文
发布时间: 2021-01-28 05:45:55
外部链接: https://www.kwm.com/en/cn/knowledge/insights/the-drug-marketing-authorization-holder-mechanism-20160706

摘要/简介Abstract

On 6 June 2016, 7 months after the China Food and Drug Administration published the Pilot Plan for the Drug Marketing Authorization Holder Mechanism (Draft for Public Opinions), the General Office of the State Council officially released the Pilot Plan for the Drug Marketing Authorization Holder Mechanism (Guo Ban Fa [2016] No. 41) (“Pilot Plan”), which attracted public attention. According to the Pilot Plan, ten provinces and municipalities, including Beijing Municipality, Tianjin Municipality, Hebei Province, Shanghai Municipality, Jiangsu Province, Zhejiang Province, Fujian Province, Shandong Province, Guangdong Province, and Sichuan Province will implement the pilot drug marketing authorization holder mechanism. This means that drug research and development (“R&D”) institutions and research personnel within the pilot regions are now eligible to apply and obtain drug marketing authorizations and drug approval numbers. The Pilot Plan will be in effect until 4 November 2018. It demonstrates China’s strong momentum to reform the drug registration mechanism in China, to stimulate drug R&D, and push for the specialization of drug R&D and manufacturing.

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