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仿制药一致性评价即将展开

2017-09-04 刘志勇 健康报

8月25日,国家食品药品监督管理总局发布公告,明确仿制药质量和疗效一致性评价相关具体要求,并发布通过一致性评价标识。公告指出,国家食药监总局将于近期开始受理或接收一致性评价申请,综合审评通过的产品,核发批准证明文件,发布公告、收入《中国上市药品目录集》,允许其使用通过一致性评价标识并享有相关政策。

8月25日,国家食品药品监督管理总局发布公告,明确仿制药质量和疗效一致性评价相关具体要求,并发布通过一致性评价标识。公告指出,国家食药监总局将于近期开始受理或接收一致性评价申请,综合审评通过的产品,核发批准证明文件,发布公告、收入《中国上市药品目录集》,允许其使用通过一致性评价标识并享有相关政策。

公告指出,国家食药监总局将公布原研企业药品清单,建议企业首先选择进口原研药品、经审核确定的原研企业在中国境内生产上市的药品、购买未进口原研药品作为参比制剂,在原研企业停止生产的情况下,可选择美国、日本或欧盟获准上市并获得参比制剂地位的药品。对国家食药监总局已公布的参比制剂,建议企业按照公布的参比制剂开展研究;企业已备案但国家食药监总局未公布参比制剂的品种,由专家咨询委员会讨论后提出指导性意见,存疑或明显不符合条件的,由企业自主决定是否继续进行研究或重新选择参比制剂,并承担相应责任。

公告明确支持中国境内企业生产的在欧盟、美国或日本批准上市的药品。已在中国上市并采用同一生产线同一处方工艺生产的,申请人可提交境外上市申报相关资料,审评通过后视同通过一致性评价。已在中国上市但采用不同生产线或处方工艺不一致的,企业可按一致性评价的要求,以境外上市申报的相关资料向国家食药监总局递交变更申请,审评通过后批准变更处方工艺,视同通过一致性评价。

公告强调,通过及视同通过一致性评价的药品,可在药品标签、说明书中使用通过一致性评价标识。同品种药品通过一致性评价的生产企业达到3家以上的,在药品集中采购等方面不再选用未通过一致性评价的品种。由于通过一致性评价的生产企业数量少而影响市场供应的国家基本药物目录品种,由国家食药监总局会同相关部委发布清单并动态调整,鼓励企业研发申报仿制药。

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    2018-08-07 zhanfl
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    2017-09-18 fengyqf

    明确仿制药质量和疗效一致性评价相关具体要求

    0

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    2017-09-06 drwjr
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    2017-09-06 huagfeg
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    2017-09-05 大爰

    学习了谢谢分享!!

    0

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    2017-09-04 131****1460

    学习了受益匪浅

    0

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    2017-09-04 有备才能无患

    由于通过一致性评价的生产企业数量少而影响市场供应的国家基本药物目录品种.由国家食药监总局会同相关部委发布清单并动态调整.鼓励企业研发申报仿制药.

    0

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