仿制药一致性评价怎么查找原研制剂信息?FDA中 DatabasesDrugs@FDA输入药物的活性成分,点击商品名,里面有RLD的显示。 A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. RLD即为参比制剂,仿制药进行生物等效性评价的参考药物。查看更多