国内外临床试验用药品监管政策对比研究

Comparative study on supervision policy of drugs for clinical trials between China and oversea

我国目前还没有具体的法规对临床试验用药品的监督管理给予明确的规定,在这个领域的监管规范还比较欠缺,而国际上欧盟和美国对临床试验用药品的生产管理都加强了监管,并颁布有非常详细的指导性文件。笔者在对欧盟EMA、美国FDA、ICH有关临床试验用药品生产质量管理法规进行全面总结的基础上,对国内外临床试验用药品的监管政策进行全面的对比分析,希望能够借鉴国际上的成熟经验,为我国临床试验用药品的监管提供参考。

There is still no definite national regulation or law on the supervision and management of drugs for clinical trials and the supervision regulation in this area is relatively insufficient. However, European Union and USA have strengthened the production and management of drugs for clinical trials and released very detailed guidance documents. In this article, we comprehensively summarized regulation and laws on the production quality management of drugs for clinical trials issued by EMA, FDA and ICH and conducted a comparative analysis on supervision policy of drugs for clinical trials between China and oversea. We hope that this article may give insight and reference on on the supervision and management of drugs for clinical trials.