生物制品批签发信息将可查询

2018-01-05 刘志勇 健康报

近日,国家食品药品监督管理总局发布修订后的《生物制品批签发管理办法》。

近日,国家食品药品监督管理总局发布修订后的《生物制品批签发管理办法》。

新《办法》强化企业主体责任,明确进口生物制品批签发申请人是境外制药企业,境外制药企业应授权其驻我国境内办事机构或我国境内企业法人作为代理人办理批签发;明确了批签发信息系统管理及信息公开的要求,公众和批签发申请人可通过信息系统查询批签发进度、签发结论等。新《办法》自2018年2月1日起施行。

批签发是指国家食品药品监管部门为确保疫苗等生物制品的安全、有效,在每批产品上市前,由指定的药品检验机构对其进行审核、检验及签发的监督管理行为。新《办法》细化完善了产品批签发的申请程序,增加了主动沟通、问题处理、风险管理的处理要求。

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    2018-01-06 1e0e5a1fm42(暂无匿称)

    henhao

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    2018-01-05 1e0e5697m83(暂无匿称)

    henhao

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    2018-01-05 1e0e5a1fm42(暂无匿称)

    henhao

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    2018-01-05 139****0239

    henhao

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    2018-01-05 神功盖世

    0

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