化学药品注射剂仿制药一致性评价技术要求征求意见

2019-10-16 包雨朦 澎湃新闻

10月15日,国家药监局就《化学药品注射剂仿制药质量和疗效一致性评价技术要求(征求意见稿)》(以下简称《技术要求》)、《已上市化学药品注射剂仿制药质量和疗效一致性评价申报资料要求(征求意见稿)》(以下简称《申报要求》)公开征求意见。《技术要求》对参比制剂、处方工艺技术、原辅包质量控制技术、质量研究与控制技术、稳定性研究技术、特殊注射剂一致性评价、改规格注射剂、药品说明书、药品标准、无需开展一致性评

10月15日,国家药监局就《化学药品注射剂仿制药质量和疗效一致性评价技术要求(征求意见稿)》(以下简称《技术要求》)、《已上市化学药品注射剂仿制药质量和疗效一致性评价申报资料要求(征求意见稿)》(以下简称《申报要求》)公开征求意见。

《技术要求》对参比制剂、处方工艺技术、原辅包质量控制技术、质量研究与控制技术、稳定性研究技术、特殊注射剂一致性评价、改规格注射剂、药品说明书、药品标准、无需开展一致性评价的品种等多个方面明确了相关要求。

其中,氯化钠注射液、葡萄糖注射液、葡萄糖氯化钠注射液、注射用水、部分放射性药物(如锝〔99mTc〕)等品种无需开展一致性评价,但需进行质量提升研究,灭菌工艺、滤器与包材选择(含相容性研究)等应符合相关技术要求。

注射剂由于其给药特点,各国药监部门均将其视为风险程度较高的品种之一。2018年4月,国家药品监督管理局发布的《国家药品不良反应监测年度报告(2017年)》显示,按剂型统计,2017年化学药品不良反应/事件报告中,注射剂占66.7%、口服制剂占30.3%。并且在国内的仿制药市场中,注射剂相比口服制剂的份额更大,占比近60%。

早在2017年12月,国家药监局药品评审中心就曾发布《已上市化学仿制药(注射剂)一致性评价技术要求(征求意见稿)》。不过,因为种种原因,在发布这一版《征求意见稿》之后,化学仿制药注射剂一致性评价一直未有新进展。

数据显示,截至10月9日,仅12个注射剂有企业通过或视同通过一致性评价。另外,目前已有291个注射剂公布了参比制剂。

兴业证券的研报分析认为,评价技术要求对国内注射剂企业提出新挑战。此次发布的一致性评价技术要求(征求意见稿),要求企业全面了解已上市注射剂的国内外上市背景、安全性和有效性数据、上市后不良反应监测情况,评价和确认其临床价值,对参比制剂、处方工艺、原辅包、质量研究与控制、稳定性及特殊注射剂/改规格注射剂等方面都明确了具体的要求,并明确了可以豁免的品种。整体来看,此次文件对于国内企业涉及注射剂的的原料药、辅料、包材、灌装等工艺以及改规格、改基团品种都提出了更高的要求。推动国内化学仿制药的立项从“仿标准”到“仿品种”升级,建立和健全注射剂仿制研发的风险质控体系,全面提升我国注射剂仿制药的质量水平。

另一方面,注射剂一致性评价工作的推进也为之后注射剂纳入带量采购进行了铺垫,参与带量采购的注射剂品种数量也将逐步提升,未来这一市场将面临价格调整。在刚刚结束的联盟地区药品集中采购中,竞价的25个品种中仅有3个为注射剂,共5家企业中选。相比口服制剂的残酷竞争,目前注射剂市场竞争格局良好,中标价格下行压力小。

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    2020-06-07 zhanfl
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    2019-10-18 drwjr
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    2019-10-18 zchen
  5. [GetPortalCommentsPageByObjectIdResponse(id=1949942, encodeId=886b1949942ff, content=<a href='/topic/show?id=f8c0503517b' target=_blank style='color:#2F92EE;'>#征求意见#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50351, encryptionId=f8c0503517b, topicName=征求意见)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=bf3d82, createdName=zhaohui6731, createdTime=Tue May 05 14:29:00 CST 2020, time=2020-05-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1906934, encodeId=f1f3190693441, content=<a href='/topic/show?id=d91e1943441' target=_blank style='color:#2F92EE;'>#一致性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19434, encryptionId=d91e1943441, topicName=一致性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3138208, createdName=zhanfl, createdTime=Sun Jun 07 10:29:00 CST 2020, time=2020-06-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261511, encodeId=e9b112615117b, content=<a href='/topic/show?id=b56025592eb' target=_blank style='color:#2F92EE;'>#仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25592, encryptionId=b56025592eb, topicName=仿制药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08e964, createdName=drwjr, createdTime=Fri Oct 18 03:29:00 CST 2019, time=2019-10-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1371337, encodeId=64c013e133723, content=<a href='/topic/show?id=d984649e455' target=_blank style='color:#2F92EE;'>#注射剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64974, encryptionId=d984649e455, topicName=注射剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5380325, createdName=zchen, createdTime=Fri Oct 18 03:29:00 CST 2019, time=2019-10-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1395257, encodeId=c755139525e9d, content=<a href='/topic/show?id=bd1a33520b2' target=_blank style='color:#2F92EE;'>#化学药品#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=33520, encryptionId=bd1a33520b2, topicName=化学药品)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/xkicoVBAnV4HxvdCqC1viaW8wdLQdN9hVP9icgqqDsxC6UVPjfhogdfc2iaU1xNUMVlFl5QicicWrjWQBTsVye5ngOQQ/132, createdBy=f92f2500185, createdName=ms7405317358118777, createdTime=Fri Oct 18 03:29:00 CST 2019, time=2019-10-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1444581, encodeId=85ec14445810a, content=<a href='/topic/show?id=3d9291459d1' target=_blank style='color:#2F92EE;'>#评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91459, encryptionId=3d9291459d1, topicName=评价)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1fee5134542, createdName=huagfeg, createdTime=Fri Oct 18 03:29:00 CST 2019, time=2019-10-18, status=1, ipAttribution=)]
  6. [GetPortalCommentsPageByObjectIdResponse(id=1949942, encodeId=886b1949942ff, content=<a href='/topic/show?id=f8c0503517b' target=_blank style='color:#2F92EE;'>#征求意见#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=50351, encryptionId=f8c0503517b, topicName=征求意见)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=bf3d82, createdName=zhaohui6731, createdTime=Tue May 05 14:29:00 CST 2020, time=2020-05-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1906934, encodeId=f1f3190693441, content=<a href='/topic/show?id=d91e1943441' target=_blank style='color:#2F92EE;'>#一致性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19434, encryptionId=d91e1943441, topicName=一致性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3138208, createdName=zhanfl, createdTime=Sun Jun 07 10:29:00 CST 2020, time=2020-06-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261511, encodeId=e9b112615117b, content=<a href='/topic/show?id=b56025592eb' target=_blank style='color:#2F92EE;'>#仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25592, encryptionId=b56025592eb, topicName=仿制药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08e964, createdName=drwjr, createdTime=Fri Oct 18 03:29:00 CST 2019, time=2019-10-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1371337, encodeId=64c013e133723, content=<a href='/topic/show?id=d984649e455' target=_blank style='color:#2F92EE;'>#注射剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64974, encryptionId=d984649e455, topicName=注射剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5380325, createdName=zchen, createdTime=Fri Oct 18 03:29:00 CST 2019, time=2019-10-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1395257, encodeId=c755139525e9d, content=<a href='/topic/show?id=bd1a33520b2' target=_blank style='color:#2F92EE;'>#化学药品#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=33520, encryptionId=bd1a33520b2, topicName=化学药品)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/xkicoVBAnV4HxvdCqC1viaW8wdLQdN9hVP9icgqqDsxC6UVPjfhogdfc2iaU1xNUMVlFl5QicicWrjWQBTsVye5ngOQQ/132, createdBy=f92f2500185, createdName=ms7405317358118777, createdTime=Fri Oct 18 03:29:00 CST 2019, time=2019-10-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1444581, encodeId=85ec14445810a, content=<a href='/topic/show?id=3d9291459d1' target=_blank style='color:#2F92EE;'>#评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91459, encryptionId=3d9291459d1, topicName=评价)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1fee5134542, createdName=huagfeg, createdTime=Fri Oct 18 03:29:00 CST 2019, time=2019-10-18, status=1, ipAttribution=)]
    2019-10-18 huagfeg

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