远程监管在药品监管和企业管理的作用与实践

The Role and Practice of Remote Supervision in Drug Regulation and Enterprise Management

当前,信息技术与监管业务不断融合,数字化监管、移动化监管等创新监管方式的作用不断凸显。远程监管能够通过智能分析风险点准确制定监管策略,从而提高监管效率并确保药品安全。云南省药品监督管理局“以点带面”,推行“药监慧眼”工程试点,实现药品生产安全远程监管。在试点过程中,云南白药集团及其子公司通过“技术先行”“数据赋能”解决了信息化程度不同企业的数据收集、上传、预警问题,为探索药品生产智慧监管提供了新思路。“药监慧眼”工程试点的实施不但促进了企业自身信息化建设,推进质量管理系统的整合,更重要的是将生产过程可识别化,为智慧监管打通了关键一环,是药品全生命周期风险管控的有效手段。本研究总结试点项目的实施和成效,并对实现药品生产全过程可追溯、推进药品生产企业信息化建设、构建监管大数据的应用场景进行了思考,建议通过鼓励医药产业信息化、打通中药原料的追溯和监管、建立信息安全防护体系、构建智能化数据分析等措施,推动药品安全治理的网络化、智慧化、高效化。

At present,information technology and supervision activities are constantly integrating while the role of innovative regula⁃tory methods,such as digital and movable supervision are continuously highlighted.Remote supervision can improve regulatory effi⁃ciency and ensure drug safety by accurately formulating regulatory strategies through intelligent analysis of risk factors.The Medical Prod⁃ucts Administration of Yunnan Province is implementing the"drug supervision intelligent eyes"project pilot,which is carried out from points to surface,to achieve remote supervision of drug production safety.During the pilot process,Yunnan Baiyao Group and its subsid⁃iaries solved the problems of data collection,uploading,and pre-warning for enterprises with different levels of informatization through"technology first"and"data empowerment",providing new ideas for exploring intelligent supervision of drug production.The implemen⁃tation of the pilot project of the"drug supervision intelligent eyes"not only promotes the informatization construction of enterprises and facilitates the integration of quality management systems,but more importantly,it makes the production process to be identifiable and establish a key link for intelligent supervision.It is an effective approach of risk control throughout the entire life cycle of drugs.This research summarized the implementation and achievements of the pilot projects,and commented the application scenarios of achieving full traceability of drug production process,promoting informatization construction of drug production enterprises,and building regulatory big data.It is suggestted to promote the networked,intelligent,and efficient management of drug safety by encouraging the informatiza⁃tion of the pharmaceutical industry,connecting the traceability and supervision of TCM raw materials,establishing an information secu⁃rity protective system,and constructing intelligent data analysis.