NMPA统计年报:7690家药企,创新药临床品种1096 个,生物制品 73 件,128件进口药获批上市!

2021-04-21 E药经理人 E药经理人

今日NMPA发布2020年药品监督管理统计年度报告,以下为该报告的主要数据:

今日NMPA发布2020年药品监督管理统计年度报告,以下为该报告的主要数据:

879件新药临床,中药天然药仅9件

2020年国家局共批准新药临床 879 件(不包含进口药品),其中中药天然药物9件,化学药品647 件,生物制品 223 件;批准按新药申请程序申报临床申请共181件,其中中药天然药物11件,化学药品 97 件,生物制品 73 件。

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进口药604件临床获批

进口药申请审批临床共604件,上市共128件,化学药品79个,生物制品49个。其中化药批准临床380件,批准上市79件,生物制品223件获批临床,批准上市49件,中药天然药最少批准临床未1件,批准上市为0。

502.jpg

创新药临床品种1096 个,仿制药临床41件

2020年共批准创新药临床品种1096个,批准创新药生产品种20个。2020 年共批准仿制药临床41件,生产722 件。

503.jpg

 GMP检查员842 人,研究生以上学历275人

截至 2020 年底,具有药品GMP 检查员资格的人数为 842人,其中,可从事检查工作的检查员数量为 842 人。2020 年共开展药品 GMP 检查 2876 人次。其中硕士及研究生以上学历人数为275 人。

504.jpg

原料药和制剂企业最多4460家

截至 2020 年底,全国有效期内药品生产企业许可证7690个(含中药饮片、医用气体等)。从所生产产品类别看,生产原料药和制剂的企业有 4460家,生产化学药的企业有3519 家,生产中成药的企业有2160家,生产中药(含饮片)企业4357家,生产医用气体的企业有671家,生产特殊药品的企业有 224 家

科技经费总计 6.38 亿元,成功转让合同金额538.30万

 国家级及省级药品监管系统科技经费从2011年的3.5亿元逐年上升,2020 年该费用总计 6.38 亿元,其中项目经费3.56 亿元。科技项目总计 2163 项,其中软课题 261 项。成果转让31项,成果转让费合同金额538.30万元。

506.jpg 

零售连锁企业和门店31.92 万家 

截至 2020 年底,全国共有《药品经营许可证》持证企业 57.33万家。其中,零售药店24.10 万家,占经营企业数量的 42.03%,零售连锁企业和门店数量31.92万家,占比 55.68% ,批发企业1.31万家,占比 2.29%。

32 种药品进行OTC 转换 

2020 年国家局对 32 种药品进行了 OTC 转换,其中,化学药处方药转非处方药 6 件;中药处方药转非处方药26 件。

互联网销售假劣药46 件 

2020年销售假劣药 4561件,货值金额2369.27万元,吊销许可证(照)37件,移送司法机关125件其中互联网销售假劣药46 件,货值金额45.50万元,罚款金额 139.89 万元,移送司法机关6 件。 

死亡病例报告 1489 件 

2020 年国家药品不良反应监测中心共收到药品不良反应报告167.58 万份。其中严重病例 16.74 万件,死亡病例报告 1489 件。不良反应报告处理数量 10 件。

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  2. [GetPortalCommentsPageByObjectIdResponse(id=1756758, encodeId=c1881e5675896, content=<a href='/topic/show?id=79b44894033' target=_blank style='color:#2F92EE;'>#年报#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48940, encryptionId=79b44894033, topicName=年报)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d5e537222303, createdName=ms5236388012055669, createdTime=Thu Feb 03 01:37:24 CST 2022, time=2022-02-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1632615, encodeId=02811632615a1, content=<a href='/topic/show?id=aa0488034a0' target=_blank style='color:#2F92EE;'>#获批上市#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88034, encryptionId=aa0488034a0, topicName=获批上市)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=820f21933891, createdName=weiz, createdTime=Tue Jul 06 22:37:24 CST 2021, time=2021-07-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1285997, encodeId=7639128599e1a, content=<a href='/topic/show?id=77903209422' target=_blank style='color:#2F92EE;'>#创新#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32094, encryptionId=77903209422, topicName=创新)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=512a199, createdName=lilianxiang, createdTime=Fri Apr 23 02:37:24 CST 2021, time=2021-04-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1456692, encodeId=2243145669210, content=<a href='/topic/show?id=0d1494359a9' target=_blank style='color:#2F92EE;'>#进口药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=94359, encryptionId=0d1494359a9, topicName=进口药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f3745789573, createdName=oliver171, createdTime=Fri Apr 23 02:37:24 CST 2021, time=2021-04-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1476254, encodeId=f4c714e625426, content=<a href='/topic/show?id=ae0669226c3' target=_blank style='color:#2F92EE;'>#生物制品#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69226, encryptionId=ae0669226c3, topicName=生物制品)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=dd657261208, createdName=楚钟, createdTime=Fri Apr 23 02:37:24 CST 2021, time=2021-04-23, status=1, ipAttribution=)]
    2021-07-06 weiz
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