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食药监总局拟规定三类注射剂不再批准上市

2017-05-14 18:30:17   

据中国之声《新闻和报纸摘要》报道,国家食药监总局官网日前发布《关于鼓励药品医疗器械创新加快新药医疗器械上市审评审批的相关政策(征求意见稿)》。对注射剂的审评和审批进一步缩紧,口服制剂能够满足临床需求、肌肉注射制剂能够满足临床需求、无明显临床优势的大容量注射剂、小容量注射剂以及注射用无菌粉针之间互改剂型三类情况下,注射剂不再批准上市。北京中医药大学法律系博士邓勇表示,政策主要目的是严控抗生素的滥用。

邓勇:我国对注射剂特别是抗生素类的注射剂的使用存在泛滥的现象,背后的原因主要是以药养医的体制、民众对抗生素存在的误解、环境中存在抗生素的残留物以及监管不力造成抗生素的滥用。(记者 刘乐)

(责编:朱江、伍振国)

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