药品批准文号申请与转让的管理创新研究

Innovation research on the administration of drug approval number application and transfer

目的探讨在我国放开药品批准文号申请及转让的制度可行性并提出建议。方法采用文献阅读法、专家咨询法及实例举证法等分析我国对于药品批准文号限制管理的现状及影响。结果我国仅限药品生产企业申请获得药品批准文号,并且不允许文号在市场上转让,实际限制了药品技术的有效流通,违背了客观规律,造成一定程度上的资源浪费及监管负担。结论在医药产业市场亟待盘活的今天,在国务院授权部分省市开展药品上市许可人制度试点的背景下,我国应逐步放开药品批准文号的申请及转让,使其更加符合市场规律及科学创新监管的需求。

Objective To study the feasibility of opening drug approval number application and its transfer system. Methods According to literature,experts＇ consultation,comparative analysis and example proof,we discussed the status and influence of drug approval number administration. Results The drug approval number has been restricted to pharmaceutical production enterprises and did not allowed to transferring between holders,which actually limited the effective circulation of production technology,violated the objective rule,and led to a waste of resource and regulatory burden to a certain extent. Conclusion With the need of revitalizing our pharmaceutical industry and expect of implementing the Marketing Authorization Holder,the application and transfer of drug approval number should be gradually opened in China in line with marketing rules and innovative regulations.