安徽鼓励仿制药研发 全国首仿有重奖

2019-01-24 吴兰 中国新闻网

记者23日从安徽省卫健委获悉,该省鼓励新药创制和鼓励仿制药研发并重,完善药品知识产权保护。医药企业每取得1个全国首仿药品生产批件,并落户安徽生产的,一次性给予200万元奖励。

记者23日从安徽省卫健委获悉,该省鼓励新药创制和鼓励仿制药研发并重,完善药品知识产权保护。医药企业每取得1个全国首仿药品生产批件,并落户安徽生产的,一次性给予200万元奖励。

近日印发的《安徽省人民政府办公厅关于改革完善仿制药供应保障及使用政策的实施意见》(简称《意见》)称,鼓励企业开展仿制药质量和疗效一致性评价的政策措施,对完成质量和疗效一致性评价的仿制药,每个品种给予一次性奖补100万元,单个企业最高可达300万元。

《意见》明确,对于已获得国家资格认定或获得备案并开展研究的安徽药物临床试验机构(GCP),给予一次性100万元奖励。

与此同时,加快建立覆盖仿制药全生命周期的质量管理和质量追溯制度。督促制药企业严格执行药品生产质量管理规范,加强对药物研发、生产、流通及使用过程的监督检查,强化责任追究,检查和处罚结果及时向社会公布。

仿制药是指与被仿制药(原研药)具有相同活性成分、剂型、给药途径和治疗作用的替代药品,具有降低医疗支出、提高药品可及性、提升医疗服务水平等重要经济和社会效益。全国近17万个药品批文中有95%以上都是仿制药。在国家289种仿制药质量和疗效一致性评价品种目录中,安徽53家企业92个品种有25家企业84个品种启动仿制药一致性评价工作,其中1个批准文号通过一致性评价。

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    2019-01-26 drwjr
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    2019-01-26 lqvr