药品注册申请人视角下我国中药新药研发主体现状研究

中药新药研发是激发中药产业发展的重要源动力。国家陆续出台了系列药品审评审批制度的改革政策以鼓励药物创新,尤其新版《药品管理法》强调药品全生命周期管理,将研制与注册独立成为专章,建立上市许可持有人制度,极大强化了新药研发环节。但从近年的注册审批情况看,目前我国中药领域的新药研发明显不足,引发对中药产业创新发展的担忧。研发主体既是药品注册领域中的新药研发者,也是直接的申请人或其密切合作方,因而,中药新药申请人的现状很大程度地反映了其研发主体的发展状态,并与中药产业的发展密切相关。旨在系统分析2007年版《药品注册管理办法》实施期间我国中药新药注册申请人的相关数据,从申请人的视角研究我国中药新药研发主体的现状与特点,为同行和相关部门提供参考。

Research on current subjects of R&D for new traditional Chinese medicine in China from perspective of drug registration applicants

The research and development (R&D) of new traditional Chinese medicine (TCM) is the vital source of motivation for the TCM industry. In recent years, a series of policies for the regulation of drug administration have been introduced to encourage drug innovation. Particularly, the new versions of the "Drug Administration Law" emphasize the management of the entire life cycle of drugs, such as the independence of R&D chapters and establishment of the marketing authorization holder system, which have greatly strengthened the significance of the R&D. However, the current status of the R&D of new TCMs in China is insufficient from the fact of the poor registration in the recent years. The subjects of R&D are not only the developer of the new drugs but also the applicants of drug registration or their cooperation partners. Therefore, the status of applicants of new TCMs registration might largely reflect the state of the art of the subjects of R&D, which closely relate to the development of TCM industry. The applicants of new Chinese medicine registration during the implementation of the 2007 version of the "Measures for the Administration of Drug Registration" is systematically analyzed in this article, in order to study the current status of the subjects of R&D and provide a reference for counterparts and relevant government departments.