我国5.2类进口仿制药申报现状及建议

Current Situation of Application of Class 5.2 Imported Generic Drugs in China and the Corresponding Suggestions

目的:改善我国5.2类进口仿制药申报现状。方法:采集2016年3月化学药品注册新分类实施后至2022年12月期间,进口仿制药申报数量、扎堆申报、获批、注册未被批准等数据信息,并分析申报现状及存在的问题,最后从政府、企业两个方面,对改善5.2类药品整体申报现状提出建议。结果与结论:5.2类药品申报数量呈上升趋势,但存在着申报数量和获批数量少、通过率低、注册周期长、首仿药制度不完善及数据保护能力较弱等问题,因此需加大政策支持力度,提高境外仿制药企业进入中国市场的积极性,使其在竞争的环境下促进我国医药行业的可持续发展。

Objective:To improve the status of the application of Class 5.2 imported generic drugs in China.Methods:Data and information of the number of applications,repeating applications,approvals,and registration disapprovals for Class 5.2 drugs were collected starting from Year 2016 when new classification of chemical drug registration implemented until Year 2022,and analysis was conducted to find out the application status and existing problems,and suggestions were made to improve the overall registration status of Class 5.2 chemical drugs in aspects of the government and enterprise.Results and Conclusion:The number of application of Class 5.2 drugs showed an upward trend,but problems such as low applications rate,low approvals,low pass rate,long registration cycle,imperfect First Generic Drug System and week data protection capabilities exist,therefore,it is necessary to strengthen policy support to increase the enthusiasm of overseas formulators to enter the Chinese market,so as to promote sustainable development of China’s pharmaceutical industry in competitive environment.