药品注册现场核查工作改进建议

Improvement Suggestions on the Drug Registration On- Site Verification

目的为药品审评审批制度改革新形势下药品注册现场核查工作的顺利进行提供参考及建议。方法结合当前药品注册相关法律法规和药品审评审批制度改革对现场核查工作的新要求,分析药品注册核查工作的现状和核查中发现的问题,并提出有针对性的建议。结果与结论目前的药品注册现场核查判定原则条款简单,针对性不强,核查中存在数据不能溯源问题。为保证现场核查工作的高质量,建议增强法规的可操作性、建立优秀核查员队伍、建立健全的核查体系、细化核查标准、探索新核查模式,从源头确保药品安全、有效。

Objective To provide the reference method and suggestion for the reform of drug registration on- site verification system under the new situation of drug review and approval system. Methods With the current drug registration laws and regulations and drug review and approval system reform on the verification of the new requirements for verification ,the current status of drug registration on- site verification and verification problems were analyzed, and the experience and suggestions were put forward. Results and Conclusion The current registration principle of the on- site verification is simple, the verification is not strong enough ,and the existed data cannot be traced back to the problem. In order to ensure the high quality of on- site verification, it is recommended to enhance the operability of the regulations, establish a good inspector team, establish a sound verification system, uniform refinement of the verifi- cation standards,explore new verification mode,to ensure drug safety and effective from the source.