Comparative Studies On Drug Recall System Between China And America

Nowadays, with the rapid development of socialist market economy and the improvement of science and technology, China’s medical industry has also made rapid development, to meet the growing drug needs of public. But at the same time, it also leads to drug quality problems and adverse drug events. The concerning of "Drug Administration Law" is only the guiding of fake or substandard pharmaceuticals. It makes some qualified drug with hidden danger without any legal restriction. Though "Drug Recall Administration" was announced, there are also some problems. For example obscure recalled objects, unreasonable recalling procedure and lightly penalty. The above problems make drug recall hard to be implemented. Based on these situations, our government should establish a suitable drug recall system.Firstly, this paper tries to specify the concept of "drug" which should be recalled, and expounds the development of drug recall system. Secondly, it analyzes the situation of China’s drug recall system. Thirdly, it introduces the drug recall system in America. Then, it compares the drug recall system of China&America. Lastly, it gives some advice about how to improve China’s drug recall system.The content of this article mainly focus on:①introducing objects of recall②analyzing the situation and implement obstacles of China’s drug recall system in depth③introducing the drug recall system of USA④comparing the relevant content of drug recall system between China&USA⑤coming up with some thinking and suggestions of China’s drug recall system.Compared with some relevant reference, this article has some innovation. By comparing&analyzing information form FDA and SFDA website, it discussed the difference of procedure and social regulation subject about drug recall between China and USA. Combined with the status and problems of drug recall in China, this paper proposed legislative models for drug recall, and imagines about how to construct main social regulation institution and responsibilities of relevant sides. It makes sense in theory and practice.