抗癌药物风险评估和风险降低计划的现状分析

发布时间：2018-01-12 08:03

本文关键词：抗癌药物风险评估和风险降低计划的现状分析　出处：《中国药学杂志》2016年01期 　论文类型：期刊论文

【摘要】：目的对美国FDA关于抗癌药物的风险评估和风险降低计划(REMS)的实施现状和特点进行综述和分析。方法根据FDA对药物实行风险评估和风险降低计划的要求,跟踪查阅有关抗癌药物风险评估和风险降低计划的实施和撤销情况,分析探讨抗癌新药风险降低的动态管理。结果风险评估和风险降低计划是FDA为确保临床药品的安全使用而制订的文件,虽然多数抗癌药物的风险评估和风险降低计划包含复杂内容,但抗癌药物风险评估和风险降低计划的实施比例并不比非抗癌药物高很多,这主要是由于癌症及其治疗的特殊性所决定,肿瘤临床的多环节协调把关以及新型靶位治疗药物对癌细胞的特异性和选择性在一定程度上降低了实施风险评估和风险降低计划的必要性。结论风险评估和风险降低计划文件在促进新药研发和保证治疗安全有效方面发挥了积极作用,其制订实施需要根据不同药物的特性和临床中出现的新问题而定。
[Abstract]:Objective to evaluate the risk assessment and risk reduction of anticancer drugs by FDA in the United States. Methods according to the requirements of FDA for drug risk assessment and risk reduction plan. Follow up on the implementation and withdrawal of risk assessment and risk reduction plans for anticancer drugs. To analyze and discuss the dynamic management of risk reduction of new anticancer drugs. Results risk assessment and risk reduction plan are the documents developed by FDA to ensure the safe use of clinical drugs. Although the risk assessment and risk reduction plans for most anticancer drugs are complex, the implementation rate of the risk assessment and risk reduction plans for anticancer drugs is not much higher than that for non-anticancer drugs. This is largely due to the specificity of cancer and its treatment. The multi-link coordinated screening of tumor clinical and the specificity and selectivity of new target therapy drugs to cancer cells reduce the necessity of implementing risk assessment and risk reduction plan to some extent. Conclusion risk assessment and risk reduction are necessary. The reduction Plan document has played an active role in promoting the development of new drugs and ensuring the safety and effectiveness of treatment. Its formulation and implementation need to be based on the characteristics of different drugs and new clinical problems.
【作者单位】：浙江海正药业股份有限公司药政注册中心;中国医学科学院药物研究所;
【分类号】：R95
【正文快照】： 美国FDA实行的处方药用户收费法案(Prescription DrugUser Fee Act,PDUFA)有力促进了创新药物尤其是抗癌新药的研发上市过程,但随着新药上市过程的加快,也为新药临床应用的安全性带来隐忧。为了保证新药上市的安全性,FDA随后对新药的研究开发及上市应用过程强化了风险管理的概

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