The Study On Legal Issues Of Chinese Drug Recall System

In this paper, the current situation of the Chinese drug recall system and the existing problems in the implementation process were analyzed, and emphasis was laid on the illustration of the legal institutional foundation for the drug recall system, drug recall procedures, the host organization settings for the social regulation of the drug recall, adverse drug reaction report system and the compensation for the drug recall, etc. on the basis of the regulation theory and legal theory by combining with the Chinese drug recall practice and referring to the advanced experience of the drug recall system in various countries. It was advocated to guarantee the implementation of the drug recall through strengthening the legislation and enlarge the supervision force when the Chinese drug system is still imperfect at present. Perfect imagination for the host organization settings for the social regulation of the Chinese drug recall was carried out by referring to the specifically-divided host organization settings for the social regulation of the American drug recall. Meanwhile, it was considered that there were problems in the monitoring of the adverse drug reaction in China, the construction of the adverse drug reaction test system should be strengthened and the report system for the adverse drug reaction should be perfected. The two models for the adverse drug reaction, including the insurance compensation and fund remedy, were compared, and the remedy model for drug recall was proposed, namely the fund model from the perspective of public welfare dominated, while other models including the insurance compensation served as complement.