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提供仿制药一致性评价一站式整体解决方案

我公司自建实验室进行体外实验,与食品药品监督管理总局核查中心专家,7.22核查带队组长李正奇博士合作,开展BE实验。我们以最高标准进行BE的数学模型推导、预BE(动物试验)、正式BE,以确保项目的高通过率。对于部分产品,可以免BE试验,大大降低一致性评价的费用,缩短一致性评价的时间。

2016年26日,国务院办公厅正式发布了《关于开展仿制药质量与疗效一致性评价的意见》(国办发【20168号),意见要求,国家基本药物目录(2012年版)中2007101日前批准上市的化学药品仿制药口服固体制剂,应在2018年底前完成一致性评价,其中需开展临床有效性试验和存在特殊情形的品种,应在2021年底前完成一致性评价;逾期未完成的,不予再注册。现将仿制药质量及疗效一致性评价(以下简称仿制药一致性评价)的相关内容介绍如下:

一、什么是仿制药一致性评价?

仿制药一致性评价,就是将仿制药与原研药(参比制剂)通过体内外实验进行比较,评估两者之间的质量和疗效是否一致。包括以下环节及内容。



二、仿制药一致性评价的流程。

三、企业如何应对?

        1、仿制药一致性评价必须做,国务院发文了,不做不行!

2、因为时间紧,要求严,相应资源紧缺,企业越早做越好!

3、在资金紧张的情况下,企业可以选择销量大、利润高的品种,以及做起来简单,较有把握通过的品种先做,或者只先做药学一致性评价(体外试验)。

4、除特大型企业外,建议企业最好委托代理公司全过程负责。企业不需要招聘专门从事仿制药一致性评价的专业人员,效率高,总的投入少,通过评价的可能性更高。

四、仿制药一致性评价所需费用测算

随着做仿制药一致性评价的企业和品种越来越多,时间越临近限定日期,所需费用只会越来越高。因产品不同,所需费用相差较大。以易溶的单一成份的化学药为例,将所需费用简要介绍如下:

(一)、不需做处方及工艺变更的体外实验费用(含税约80万)

(二)、涉及处方及工艺变更的体外实验费用(含税价200万)

(三)、BE实验费用(约需450500万元,约需6-12个月)

BE实验分为实验方案制定、BE备案、BE实验操作、资料编写及申报。在具体的实验时,又分筛选期、治疗期及随访期。筛选期包括筛选日早餐、签订知情同意、人口学资料、病史及用药史、生命体征、体格检查、心电图、病毒学、血常规、尿常规、血生化、酒精筛查、尿药检、X胸片、性激素等检查,以及血液样品采集、入排标准审查、一次性耗材等。治疗期和随访期除了各类检查,还包括医生观察费、护士护理费、夜班费、CRF填写费、专科医生劳务费、质控服务费、CRC服务费、AE/SAE评估费等,另外还有其他费用,包括方案讨论修费、制定费、项目管理费、药物管理费、文件归档费、报告管理费、医院管理费、招募管理费、受试者补偿费。

上述各项费用根据品种的不同、以及不同的时间段进行,费用总额会有调整。如有品种需要进行预算,请将品种名称及规格发给我们,我们给您具体的报价。



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