国外药物撤销、限制使用的情况对我国药品评价的启示

Inspiration From the Drug withdrawing and Limited Using Abroad

本文对国外药物撤出市场的常见原因进行了分析,对药物自上市至撤出市场的时间以及药物不良反应“时滞现象”的原因进行了总结,并提出对我国药品评价工作的一些思考:重视药物上市前、后的综合评价;加强同类药物的对比研究,药物相互作用的研究,药物上市后的不良反应监测和药物的再评价;跟踪和分析国外药物安全性信息;注重药品说明书的书写与动态的修改等。

Analyzed the reasons for withdrawing drugs from the market,summarized the period of time from drugs coming into the market to being retreated,and the ground for ' time lag' of drug adverse reactions.put forward some views on drug assessment inchina:Emphasize the pre and post marketing comprehensive evaluation of drug;Strengthen the drug comparative studies,drug interaction studies and the post-marketing surveillance of drug adverse reactions ;Follow up and analyze the foreign information on drug safety ;Pay attention to the standardized writing of drug instruction and its revising.