山东省保障药品生产质量安全的监管实践与思考

Regulatory Practice and Thinking on the Quality and Safety of Pharmaceutical Production of Shandong Province

山东省是医药产业大省,药品生产相关企业数量众多,药品生产监管任务繁重。近年来,山东省药监局积极探索新形势下药品生产企业全生命周期主体责任落实新思路,构建协同高效的药品生产监管制度机制。本文从各方责任落实、推动科学监管、服务产业发展等方面介绍了药品生产监管实践与思考,以期推动山东省不断提升药品生产监管和服务发展能力,保障公众用药安全有效。

Shandong Province is a major province of pharmaceutical industry,with a large number of drug manufacturers and heavy tasks of regulating pharmaceutical production.In recent years,Shandong Medical Products Administration has actively explored new ideas on the implementation of principal responsibility in the whole life cycle of drug manufacturers under the new situation,and built a collaborative and efficient mechanism for pharmaceutical production.This article introduces the regulatory practice and thinking on the quality and safety of pharmaceutical production from the aspects of promoting the implementation of responsibilities of all parties,enhancing scientific regulatory and facilitating the development of service industry,in order to promote Shandong Province to continuously improve the ability of drug production supervision and service development,and ensure the safety and effectiveness of public drug use.