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| Enlightenment of foreign tumor immunotherapy regulation to China |
| LIU Yongjun1 CHENG Yuqing1 WANG Yan2 |
1.Shool of International Pharmaceutical Business, China Pharmaceutical University, Jiangsu Province, Nanjing 211198, China;
2.Jiangsu Cell Tech Co., Ltd, Jiangsu Province, Changzhou 213000, China |
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Abstract Tumor immunotherapy has made important progress in recent years, but still be a chaotic situation because of the imperfection of related system and lack of standard production and treatment procedures in China. To improving tumor immunotherapy regulations, this paper analyzes tumor immunotherapy policies at present, and studies international advanced biological therapy research and regulatory conditions by the methods of literature analysis and empirical analysis. Studies have found that in United States and Europe, tumor immunotherapy products are both regulated by corresponding biological product management offices which belongs to state drug administration, they have a strict standard system from immunotherapy clinical trials, productions and effectiveness assessments. On the other hand, Japan adopts double-track mode. The paper here suggests that treatment codes and standards of tumor immunotherapy should be issued as soon as possible, and delegate third party to supervise the strictly implement.
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