婴幼儿配方乳粉产品配方注册现场核查中的常见问题与思考

Common Problems and Perspective of On-site Audit for Infant Formula Registration Application

婴幼儿配方乳粉产品配方注册现场核查是配方注册技术审评的重要环节,主要核查申请人提交的产品配方注册申请材料的真实性,以及与实际研发情况、试制情况及原始数据的一致性,并核查申请人是否具备能够保障产品配方科学性、安全性的研发能力、生产能力和检验能力。通过对2017-2019年间历次现场核查中发现的问题进行汇总分析,对申请人、监管部门等提出了相关建议,以期对申请人的注册申请及现场核查的组织实施有一定的借鉴作用。

The on-site audit of infant formula registration application is an important step in the technical evaluation of formula registration,mainly verifying the authenticity of the formula registration application documents submitted by the applicants, as well as the consistency of the original data in research and development, trial production and so on. In addition, it is necessary to check whether the applicant has the capability of research and development, production and test to ensure the scientificity and safety of infant formula in on-site audit. Common problems found in previous on-site audits from 2017 to 2019 were summarized and analyzed, and relevant suggestions were put forward,which will provide some references for infant formula registration application and the organization of on-site audit in future.