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| Decision of the Standing Committee of the National People's Congress on Authorizing the State Council to Conduct the Pilot Program of the System of the Holders of Drug Marketing Licenses in Certain Areas and the Relevant Issues | | 全国人民代表大会常务委员会关于授权国务院在部分地方开展药品上市许可持有人制度试点和有关问题的决定 |
| (Adopted at the 17th session of the Standing Committee of the Twelfth National People's Congress on November 4, 2015) | | （2015年11月4日第十二届全国人民代表大会常务委员会第十七次会议通过） |
| In order to promote the reform of the drug review and approval system, encourage drug innovation, improve drug quality, and provide practical experience for the further reform and improvement of the drug administration system, it is decided at the 17th session of the Standing Committee of the Twelfth National People's Congress: | | 为了推进药品审评审批制度改革，鼓励药品创新，提升药品质量，为进一步改革完善药品管理制度提供实践经验，第十二届全国人民代表大会常务委员会第十七次会议决定： |
I. The State Council is authorized to conduct the pilot program of the system of the holders of drug marketing licenses in ten provinces and municipalities directly under the Central Government, namely, Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Fujian, Shandong, Guangdong and Sichuan, and drug research and development institutions and scientific research personnel are allowed to obtain drug approval numbers and assume the corresponding liabilities for drug quality.
．．．．．． | | 一、授权国务院在北京、天津、河北、上海、江苏、浙江、福建、山东、广东、四川十个省、直辖市开展药品上市许可持有人制度试点，允许药品研发机构和科研人员取得药品批准文号，对药品质量承担相应责任。
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