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山西积极推进仿制药一致性评价 68家药企面临“生死大考”
时间:2017-08-11 点击率 : 725

新华社太原7月8日电(记者 霍瑶)记者日前从山西省政府获悉,山西省正在开展“仿制药质量和疗效一致性评价”专项行动,一致性评价“大考”开启,省内制药企业将加速洗牌,优胜劣汰。

仿制药,是指以原研药为参考对比,在剂量、安全性、质量、作用以及适应症上相同的一种仿制药品。长期以来,我国化学药物以仿制发达国家药品为主,由于早期批准的仿制药医学、药学研究基础相对薄弱,绝大部分仿制药在质量与疗效方面与原研药差异较大,低水平重复、“同药不同效”的问题尤为普遍。

“迫切需要通过开展一致性评价淘汰落后品种,真正使仿制药的质量和疗效与原研药达到一致。”山西省食品药品监督管理局局长赵光国表示,仿制药质量提高了,与原研药能相互替代了,就能够推动药品生产领域的结构性改革,改变目前原研药在医院药品销售占比过大的局面,有利于降低医药总费用支出。开展一致性评价,一让用药更加安全有效,二能减轻医药费负担,给老百姓带来直接实惠。

根据调研,国家发布的首批需做一致性评价的289个品种,山西省有124个品种、1038个药品批准文号。涉及的药品生产企业68家,占该省120家药品生产企业的56.7%。根据政策,山西省68家药企的1042个基本药物固体制剂2018年底前若通不过一致性评价,将被注销批准文号;其他企业的近3000个批准文号今后几年若通不过一致性评价,将在下一个药品注册周期不再受理注册。

据了解,与全国其他多地一样,山西省药品产能严重过剩,企业数量多,一致性评价时间紧、任务重。按照“4月配齐人员、7月完成培训、8月建好病房、9月启动评价”的要求,山西将进一步加大督查力度,做好评估和验收工作。

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