非洲猪瘟诊断制品注册评审现状分析

Analysis of the Current Situation of African Swine Fever Diagnostic Test Kits Registration and Evaluation

关键词:  非洲猪瘟  诊断制品  注册评审

Key words:  African swine fever  diagnostic test kits  registration evaluation

摘要:

2018年8月，非洲猪瘟在我国沈阳首次爆发，随后蔓延至全国，给我国养猪业造成了重大经济损失。利用诊断制品对猪群非洲猪瘟感染情况进行检测与早期诊断，是预防和控制非洲猪瘟的有效手段。2019年以来，非洲猪瘟诊断制品注册申报数量居高不下，但常因申报资料存在各种问题未通过注册评审。鉴于此，对我国非洲猪瘟诊断制品注册申报情况、评审评价政策以及不符合注册要求的原因进行了分析，并提出了相关建议，供非洲猪瘟诊断制品研发、注册人员参考。

Abstract:

African swine fever (ASF) has spread across China since the first reported outbreak in Shenyang in August 2018, causing huge economic losses to swine industry. At present, the number of registration of diagnostic test kits, which function as infectious detection and early diagnosis, remains high from 2019. But products often fail to pass the registration evaluation due to various problems in the application dossiers.Here, we present the current situation of registration, the evaluation regulations and the reasons for reject about ASF diagnostic test kits. The suggestions are provided to researchers and regulatory affairs personnel for reference.