论完善我国的生物技术药物试验数据保护制度

发布时间：2018-07-08 19:56

本文选题：生物技术药物 + 试验数据　；参考：《华中科技大学》2014年硕士论文

【摘要】：药品试验数据，，是指在新药开发的各个阶段获得的测试数据,这些数据用以确定该药品的有效性、安全性和质量可控性，其商业价值的利用最集中体现于仿制药。在传统药物的语境下，假设如果没有药品试验数据的保护制度，仿制药厂商可以直接利用原研药厂商的药品试验数据来证明药品的安全、有效，而药品试验数据保护制度也因此产生。传统的仿制药有效成分单一，然而，生物仿制药的有效成分往往不是一种单一的分子，所以，生物仿制药与原创型生物技术药物的有效成分基本不可能做到完全一致，目前也没有相应的分析技术能够验证其生物等效性，即，生物仿制药只能是对原研药的一种无限接近。在此科学问题之下，如何设计出合理的生物技术药物试验数据保护制度，成为了生物仿制药产业的亟待解决的难题。本文试图通过阐述药品试验数据保护制度的内涵与生物技术药物的特殊性，综合比较借鉴国外立法经验，结合我国情况，为我国制定生物技术药物试验数据保护制度提出相关建议。
[Abstract]:Drug test data refers to the test data obtained in each stage of new drug development. These data are used to determine the effectiveness, safety and quality controllability of the drug. The commercial value of the data is most concentrated in generic drugs. In the context of traditional drugs, if there is no protection system for drug test data, generic drug manufacturers can directly use the drug test data of the original manufacturer to prove the safety and effectiveness of the drug. And the drug test data protection system is also produced as a result. Traditional generic drugs have a single active ingredient. However, the active components of biomimetic drugs are often not a single molecule, so it is almost impossible to be completely consistent with the active ingredients of original biotech drugs. At present, there is no corresponding analytical technology to verify its bioequivalence, that is, biomimetic drugs can only be a kind of infinite proximity to the original drugs. Under this scientific problem, how to design a reasonable data protection system for biotech drug testing has become a difficult problem to be solved urgently in the biomimetic drug industry. This paper attempts to elaborate the connotation of drug test data protection system and the particularity of biotechnology drugs, and to compare and draw on the experience of foreign legislation, combined with the situation of our country. Some suggestions are put forward for the establishment of data protection system for biotech drug testing in China.
【学位授予单位】：华中科技大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：D922.16

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