生物制品批签发电子证明应用调研与实施  

Investigation and Application of Electronic Certificates for Lot Release of Biological Products

作　　者：曹倩 张喆 胡康[2] CAO Qian;ZHANG Zhe;HU Kang(National Medical Products Administration Information Center,Beijing,China 100044;National Institutes for Food and Drug Control,Beijing,China 100050)

机构地区：[1]国家药品监督管理局信息中心,北京100044 [2]中国食品药品检定研究院,北京100050

出　　处：《中国药业》2023年第22期25-29,共5页China Pharmaceuticals

摘　　要：目的 推进生物制品批签发证明电子化,为企业提供更便利的服务。方法 分析当前生物制品批签发电子证明应用现状及存在的问题,多方面调研生物制品批签发业务人员对电子证明的意见与建议,结合现有生物制品批签发业务及系统现状统筹推进实施。结果 生物制品批签发企业对电子证明缺乏足够的认知,其中在认知、使用、需求、版式(一致性)4个项目选择率最高的分别为了解一点(79.10%),了解一点但没用过(49.25%),需要(50.75%),最好一致(53.73%);在功能要求上选择率最高的为快速及时送达(94.03%);认为取消批签发纸质证明最大的影响因素为如何防止电子证明被人冒用(79.10%);仍有62.69%的受访者选择需要保留纸质证明。受访对象对生物制品批签发电子证明的安全性与应用程度存有疑虑,但仍对其实施表示大力支持。结论 生物制品批签发电子证明的实施,方便了企业及时获取与管理批签发证明,提高了企业运营效率,节省了社会资源,加强了监管部门的数据共享与工作业务协同。同时建议监管部门进一步完善工作机制,加强部门间协作,加大该类证明电子化的宣传推广力度。Objective To promote the electronization of certificates for lot release of biological products,and to provide more convenient service for enterprises.Methods The current application status of electronic certificates for lot release of biological products was investigated,and the existing problems were analyzed.The opinions and suggestions of staff working for biological product lot release in related enterprises on the electronic certificates were obtained,the implementation of electronic certificates for lot release of biological products was promoted based on the existing business and system.Results Enterprises related to biological product lot release lacked sufficient understanding of electronic certificates.The primary attitude of enterprises towards the cognition,usage,needs and format requirement was as follows:understanding a little of electronic certificates for lot release(79.10%),understanding a little but having not used it before(49.25%),needing it(50.75%),hoping that the format of electronic and paper certificates for lot release was consistent(53.73%).The primary attitude towards function requirement was fast and timely delivery(94.03%).The main factor affecting the cancellation of paper certificates for lot release was how to prevent electronic certificates from being falsely used(79.10%).Precisely 62.69%of respondents thought that paper certificates were needed.The respondents had doubts about the safety and application ability of electronic certificates for lot release of biological products,but still strongly supported its implementation.Conclusion The implementation of electronic certificates for lot release of biological products facilitates enterprises to obtain and manage the lot release certificates timely,improves the operational efficiency of enterprises,saves the social resources,and strengthens the data sharing and business collaboration among regulatory departments.It is suggested that regulatory departments should further improve the work mechanism,strengthen the interdepartmental c

关 键 词：电子证明 生物制品 批签发 问卷调研 电子化 药品监管 

分 类 号：R95[医药卫生—药学]