药品监管数字化的价值评估与实现途径

Value Evaluation and Realization Approaches on Digitization of Drug Supervision and Control

摘要:

在深入剖解药品监管部门经费短缺且能力不足、制药企业刻意隐瞒、其他药评资料私密化等导致传统药监实效不彰之动因的基础上，阐明大数据环境下广域数据挖掘在实现药监元数据巨量化、引领药效认知科学化、减少涉药违规行为等方面的重要价值，提出包括改进用药数据挖掘技术、构筑病患信息加密认证系统、完善相关政策法规、适用惩罚性赔偿制度及提高第三方公开药评的物质奖励等在内的一系列推进药品监管数字化的具体举措。

Abstract:

After a detailed analysis of reasons causing ineffective drug administration, such as serious shortages of funds and professional knowledge, sedulous concealment of pharmaceutical enterprises, other undeclared drug evaluation data, the article analyses many important values of wise data mining in big data environment , such as realizing massive amount of metadata, enhancing the social scientific cognitive level of drug effects, urging relevant enterprises to improve drug tests, etc. It also proposes a series of supporting measures including improving mining technologies, digital encryption or authentication systems, political and legal norms, applying punitive compensation and raising material awards of publicly third party drug evaluation, etc.