药品是关系公众生命健康的特殊商品,各国对药品都实行严格的政府监管,以确保公众用药的安全、有效。近年来,我国发生了一系列药害事件,把药品安全监管推到了风口浪尖之上。笔者长期从事药品管理方面的工作,发现有关药事领域的立法性文件还存着若干不足之处,为此进行研究与分析,以期对我国药品安全监管的完善有所裨益。 Drugs are special commodities that have a bearing on the health and lives of the general public. All countries implement strict government regulations on medicines so as to ensure the safety and effectiveness of public medicines. In recent years, a series of phytosanitary incidents occurred in our country, pushing the supervision of drug safety onto the cusp. The author has long been engaged in the work of drug administration and found that there are still some inadequacies in the legislative documents concerning the field of pharmaceuticals. Therefore, research and analysis are conducted for this purpose in the hope of benefiting the improvement of China’s drug safety regulation.