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药品注册申请材料造假将严惩
2017-08-15 03:46:09 中国青年网
据新华社北京8月14日电(记者 丁小溪)最高人民法院、最高人民检察院14日发布《关于办理药品、医疗器械注册申请材料造假刑事案件适用法律若干问题的解释》,旨在依法惩治药品、医疗器械注册申请材料造假的犯罪行为,维护人民群众生命健康权益。
根据此次发布的司法解释,药物非临床研究机构、药物临床试验机构、合同研究组织的工作人员,故意提供虚假的药物非临床研究报告、药物临床试验报告及相关材料的,应当认定为刑法第二百二十九条规定的“故意提供虚假证明文件”。
同时,司法解释明确规定在药物非临床研究或者药物临床试验过程中故意使用虚假试验用药品的;瞒报与药物临床试验用药品相关的严重不良事件的;故意损毁原始药物非临床研究数据或者药物临床试验数据的等情形,应当认定为刑法第二百二十九条规定的“情节严重”,以提供虚假证明文件罪处五年以下有期徒刑或者拘役,并处罚金。
针对药品注册申请人自行数据造假行为的性质认定问题,司法解释规定,药品注册申请单位的工作人员,故意使用符合本解释规定的虚假药物非临床研究报告、药物临床试验报告及相关材料,骗取药品批准证明文件生产、销售药品的,应当依照刑法第一百四十一条规定,以生产、销售假药罪定罪处罚。
这个司法解释自2017年9月1日起施行。
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