美国风险评估与减轻策略对我国仿制药参比制剂的影响

The influence of USA risk evaluation and mitigation strategy on the reference listed drug of generic product in China

风险评估与减轻策略是美国FDA为减轻药品特定严重风险的发生和/或严重程度而引入的一项制约机制。然而,在该策略的执行过程中,会一定程度上限制参比制剂的流通和市场可及性,从而影响相应仿制药的上市。虽然美国FDA采取了一定的改进措施,用于支持申请美国上市的仿制药,但对国内仿制药企业获取参比制剂收效甚微。本文结合国家药品监督管理局国产药品数据库、进口药品数据库、美国Drugs@FDA药品数据库以及每日医疗(DailyMed)中的公开信息,对42个现行风险评估与减轻策略中涉及的化学药品进行了检索和分析,并根据相关品种在我国仿制药参比制剂目录中的收载情况以及在我国的上市状态,将其划分为4个类别,提出相应的应对措施,可以为药品监管机构和制药行业完善现行的仿制药参比制剂目录提供参考。

Risk evaluation and mitigation strategy is a regulatory mechanism introduced by the US Food and Drug Administration(FDA)to reduce the occurrence and/or the severity of certain serious risks of drug product.However,during the implementation of this strategy,the circulation and market availability of reference listed drug may be limited to some extent,which further affects the marketing of corresponding generic drug product.Although FDA has taken some improvement measures to support the marketing application of generic drug product in USA,it has little effect on the domestic enterprises of generic drug product to obtain the reference listed drug.Combining the public available information from the public information in the domestic drug product database,imported drug product database of the national medical products administration,as well as the knowledge in Drugs@FDA and FDA-Approved Drugs and DailyMed,the retrieval and analysis are performed to 42 programs of current risk evaluation and mitigation strategy concerning the chemical drug product.According to the status of relevant reference listed drugs in Chinese reference listed drug directories for generic drug product,as well as the domestic marketing status of drug products,it is divided into four categories,and the corresponding measures were further proposed to assist the current drug authority and the pharmaceutical industry to complete and supplement the current Chinese reference listed drug directories for generic drug products.