{"id":6622,"date":"2026-08-11T12:44:03","date_gmt":"2026-08-11T12:44:03","guid":{"rendered":"https:\/\/tsubaki-jp.com\/?p=6622"},"modified":"2026-08-11T13:10:25","modified_gmt":"2026-08-11T13:10:25","slug":"fda-approval-japan-availability-unapproved-drugs-council-zh","status":"publish","type":"post","link":"https:\/\/tsubaki-jp.com\/zh-hans\/fda-approval-japan-availability-unapproved-drugs-council-zh\/","title":{"rendered":"\u300cFDA \u6279\u51c6\u4e86\u300d\u5728\u65e5\u672c\u610f\u5473\u7740\u4ec0\u4e48\uff0c\u53c8\u4e0d\u610f\u5473\u7740\u4ec0\u4e48"},"content":{"rendered":"<p>\u65e5\u672c\u7684\u884c\u4e1a\u5a92\u4f53\u6bcf\u6708\u90fd\u4f1a\u505a\u4e00\u671f\u300c\u4e0a\u4e2a\u6708 FDA \u6279\u4e86\u4ec0\u4e48\u300d\u7684\u6c47\u603b\uff0c2026 \u5e74 7 \u6708\u8fd9\u671f\u53d1\u5728 8 \u6708 7 \u65e5\u3002\u4e0e\u5176\u9010\u4e2a\u836f\u590d\u8ff0\uff0c\u672c\u6587\u56de\u7b54\u7684\u662f\u8fd9\u7c7b\u6c47\u603b\u4e00\u51fa\u6765\u6211\u4eec\u771f\u6b63\u4f1a\u88ab\u95ee\u5230\u7684\u95ee\u9898\uff1a\u7f8e\u56fd\u6279\u4e86\uff0c\u65e5\u672c\u4ec0\u4e48\u65f6\u5019\u80fd\u6709\uff1f\u8d70\u54ea\u6761\u8def\uff1f<\/p>\n<p><strong>\u5148\u8bf4\u4e00\u53e5\u4f53\u4f8b\u3002<\/strong>\u4e0b\u6587\u4e0d\u5199\u4efb\u4f55\u4e00\u4e2a\u5177\u4f53\u836f\u54c1\u7684\u9002\u5e94\u75c7\u3001\u7528\u6cd5\u7528\u91cf\u6216\u6709\u6548\u6027\u6570\u636e\u3002\u7f8e\u56fd\u6279\u51c6\u540d\u5355\u4e0a\u7684\u54c1\u76ee\u591a\u6570\u5728\u65e5\u672c\u5c1a\u672a\u83b7\u6279\uff0c\u65e5\u672c\u300a\u533b\u836f\u54c1\u533b\u7597\u5668\u68b0\u6cd5\u300b\uff08\u85ac\u6a5f\u6cd5\uff09\u5bf9\u672a\u83b7\u6279\u836f\u54c1\u53ef\u4ee5\u516c\u5f00\u7684\u5185\u5bb9\u6709\u660e\u786e\u9650\u5236\u3002\u4ee5\u4e0b\u53ea\u8bb2\u5236\u5ea6\u3002<\/p>\n<h2>2026 \u5e74 7 \u6708\u90a3\u4efd\u540d\u5355\u5b9e\u9645\u5305\u542b\u4ec0\u4e48<\/h2>\n<p><strong>\u6309 FDA \u81ea\u5df1\u7684\u300cNovel Drug Approvals for 2026\u300d\u9875\u9762\uff0c2026 \u5e74 7 \u6708\u5171\u6709 6 \u9879\u65b0\u836f\u83b7\u6279\uff0c\u65e5\u671f\u5206\u522b\u662f 7 \u65e5\u300114 \u65e5\u300115 \u65e5\u300122 \u65e5\uff0c\u4ee5\u53ca 24 \u65e5\u7684\u4e24\u9879\u3002<\/strong>\u540c\u4e00\u9875\u9762\u8bb0\u5f55 2026 \u5e74\u81f3\u4eca\u5171 30 \u9879\u65b0\u836f\u83b7\u6279\uff0c\u9875\u9762\u6807\u6ce8\u7684\u5185\u5bb9\u66f4\u65b0\u65e5\u4e3a 2026 \u5e74 8 \u6708 5 \u65e5\u3002<\/p>\n<p>\u5bf9\u6bd4\u4e0d\u540c\u6765\u6e90\u65f6\u6709\u4e00\u70b9\u8981\u7559\u610f\uff1aFDA \u8fd9\u4efd\u540d\u5355\u7edf\u8ba1\u7684\u662f CDER \u5ba1\u8bc4\u7684\u65b0\u5206\u5b50\u5b9e\u4f53\u4e0e\u65b0\u6cbb\u7597\u7528\u751f\u7269\u5236\u54c1\uff0c<strong>\u4e0d\u542b<\/strong>\u5df2\u83b7\u6279\u836f\u54c1\u7684\u9002\u5e94\u75c7\u6269\u5927\uff0c\u4e5f<strong>\u4e0d\u542b<\/strong>\u751f\u7269\u7c7b\u4f3c\u836f\u3002\u884c\u4e1a\u5a92\u4f53\u7684\u6708\u5ea6\u6c47\u603b\u901a\u5e38\u4e09\u8005\u4e00\u8d77\u7b97\uff0c\u6240\u4ee5\u540c\u4e00\u4e2a\u6708\u5b83\u4eec\u7ed9\u51fa\u7684\u6570\u5b57\u4f1a\u6bd4 FDA \u9ad8\u3002\u4e24\u4e2a\u6570\u5b57\u90fd\u6ca1\u9519\uff0c\u53ea\u662f\u56de\u7b54\u7684\u95ee\u9898\u4e0d\u540c\u3002<\/p>\n\n\n<figure class=\"wp-block-image size-full tsubaki-illustration--fda-monthly-count\" data-tsubaki-illustration=\"fda-monthly-count\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/fda-july-six-novel-drug-count.webp\" alt=\"Monthly approval register with six marked entries and separate categories outside the FDA novel drug count.\" class=\"wp-image-6635\" width=\"1672\" height=\"941\" srcset=\"https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/fda-july-six-novel-drug-count.webp 1672w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/fda-july-six-novel-drug-count-300x169.webp 300w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/fda-july-six-novel-drug-count-1024x576.webp 1024w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/fda-july-six-novel-drug-count-768x432.webp 768w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/fda-july-six-novel-drug-count-1536x864.webp 1536w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/fda-july-six-novel-drug-count-600x338.webp 600w\" sizes=\"auto, (max-width: 1672px) 100vw, 1672px\" \/><\/figure>\n\n<h2>\u4e3a\u4ec0\u4e48\u300cFDA \u6279\u4e86\u300d\u4e0d\u7b49\u4e8e\u300c\u65e5\u672c\u80fd\u7528\u300d<\/h2>\n<p>\u7f8e\u56fd\u7684\u6279\u51c6\u5728\u65e5\u672c\u4e0d\u4ea7\u751f\u4efb\u4f55\u6548\u529b\u3002\u5728\u65e5\u672c\u4e0a\u5e02\u9500\u552e\u4e00\u6b3e\u836f\u54c1\uff0c\u9700\u8981\u4f9d\u85ac\u6a5f\u6cd5\u53e6\u884c\u53d6\u5f97\u65e5\u672c\u7684\u627f\u8a8d\uff0c\u7531\u65e5\u672c\u65b9\u9762\u5bf9\u8be5\u54c1\u76ee\u81ea\u5df1\u7684\u7533\u62a5\u8d44\u6599\u505a\u5ba1\u8bc4\u3002\u4e24\u5957\u5236\u5ea6\u5e76\u884c\u8fd0\u4f5c\uff0c\u4e00\u4e2a\u54c1\u76ee\u53ef\u80fd\u5728\u7f8e\u56fd\u83b7\u6279\u591a\u5e74\uff0c\u65e5\u672c\u8fde\u7533\u8bf7\u90fd\u8fd8\u6ca1\u63d0\u4ea4\uff0c\u4e5f\u53ef\u80fd\u6c38\u8fdc\u4e0d\u4f1a\u63d0\u4ea4\u3002<\/p>\n<p>\u8fd9\u4e2a\u843d\u5dee\u5c31\u662f\u4e3a\u4ec0\u4e48\u4e00\u4efd\u7f8e\u56fd\u6279\u51c6\u540d\u5355\u5bf9\u65e5\u672c\u8bfb\u8005\u6709\u53c2\u8003\u4ef7\u503c\u3001\u4f46\u4e0d\u80fd\u76f4\u63a5\u636e\u4ee5\u884c\u52a8\u3002\u771f\u6b63\u6709\u7528\u7684\u95ee\u9898\u4e0d\u662f\u300c\u6279\u4e86\u6ca1\u6709\u300d\uff0c\u800c\u662f\u300c\u5b83\u5728\u65e5\u672c\u7684\u7ba1\u7ebf\u4e0a\u5904\u5728\u54ea\u4e00\u683c\u300d\u3002<\/p>\n\n\n<figure class=\"wp-block-image size-full tsubaki-illustration--independent-approval-systems\" data-tsubaki-illustration=\"independent-approval-systems\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/us-japan-independent-approval-systems.webp\" alt=\"Parallel United States and Japan regulatory tracks showing that approval in one system does not transfer automatically.\" class=\"wp-image-6636\" width=\"1672\" height=\"941\" srcset=\"https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/us-japan-independent-approval-systems.webp 1672w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/us-japan-independent-approval-systems-300x169.webp 300w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/us-japan-independent-approval-systems-1024x576.webp 1024w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/us-japan-independent-approval-systems-768x432.webp 768w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/us-japan-independent-approval-systems-1536x864.webp 1536w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/us-japan-independent-approval-systems-600x338.webp 600w\" sizes=\"auto, (max-width: 1672px) 100vw, 1672px\" \/><\/figure>\n\n<h2>\u65e5\u672c\u628a\u6d77\u5916\u5df2\u83b7\u6279\u836f\u54c1\u5f15\u8fdb\u6765\u7684\u5b98\u65b9\u901a\u9053<\/h2>\n<p><strong>\u9488\u5bf9\u8fd9\u79cd\u60c5\u51b5\uff0c\u65e5\u672c\u6709\u4e00\u4e2a\u5e38\u8bbe\u673a\u5236\uff1a\u539a\u751f\u52b3\u52a8\u7701\u53ec\u96c6\u7684\u300c\u533b\u7642\u4e0a\u306e\u5fc5\u8981\u6027\u306e\u9ad8\u3044\u672a\u627f\u8a8d\u85ac\u30fb\u9069\u5fdc\u5916\u85ac\u691c\u8a0e\u4f1a\u8b70\u300d\uff08\u9ad8\u533b\u7597\u9700\u6c42\u672a\u83b7\u6279\u836f\u4e0e\u8d85\u8bf4\u660e\u4e66\u7528\u836f\u7814\u8ba8\u4f1a\u8bae\uff09\u3002<\/strong>\u7531\u5b66\u4f1a\u63d0\u51fa\u8981\u671b\uff0c\u4f1a\u8bae\u8bc4\u4f30\u533b\u7597\u4e0a\u7684\u5fc5\u8981\u6027\uff1b\u8ba4\u5b9a\u5fc5\u8981\u6027\u9ad8\u7684\uff0c\u7531\u539a\u751f\u52b3\u52a8\u7701\u5411\u4f01\u4e1a\u53d1\u51fa\u5f00\u53d1\u8981\u8bf7\uff0c\u6216\u516c\u5f00\u5f81\u96c6\u5f00\u53d1\u4f01\u4e1a\u3002<\/p>\n\n\n<figure class=\"wp-block-image size-full tsubaki-illustration--official-development-pathway\" data-tsubaki-illustration=\"official-development-pathway\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/japan-unapproved-drug-official-pathway.webp\" alt=\"Four-stage illustration of a professional society request, expert review, development request and company development.\" class=\"wp-image-6637\" width=\"1672\" height=\"941\" srcset=\"https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/japan-unapproved-drug-official-pathway.webp 1672w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/japan-unapproved-drug-official-pathway-300x169.webp 300w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/japan-unapproved-drug-official-pathway-1024x576.webp 1024w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/japan-unapproved-drug-official-pathway-768x432.webp 768w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/japan-unapproved-drug-official-pathway-1536x864.webp 1536w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/japan-unapproved-drug-official-pathway-600x338.webp 600w\" sizes=\"auto, (max-width: 1672px) 100vw, 1672px\" \/><\/figure>\n\n<p>\u6309\u539a\u751f\u52b3\u52a8\u7701\u516c\u5e03\u7684\u8303\u56f4\uff0c\u6db5\u76d6\u4e09\u79cd\u60c5\u5f62\uff1a<\/p>\n<ul>\n<li>\u5728\u7f8e\u56fd\u3001\u82f1\u56fd\u3001\u5fb7\u56fd\u3001\u6cd5\u56fd\u3001\u52a0\u62ff\u5927\u3001\u6fb3\u5927\u5229\u4e9a\u4efb\u4e00\u56fd\u5df2\u83b7\u6279\uff0c\u800c\u65e5\u672c\u672a\u83b7\u6279\u7684\u836f\u54c1<\/li>\n<li>\u5728\u4e0a\u8ff0\u56fd\u5bb6\u5df2\u83b7\u6279\u3001\u6216\u5df2\u88ab\u5e7f\u6cdb\u4f7f\u7528\uff0c\u800c\u65e5\u672c\u672a\u83b7\u6279\u7684\u9002\u5e94\u75c7<\/li>\n<li>\u6b27\u7f8e\u540c\u6837\u672a\u83b7\u6279\u7684\u54c1\u76ee\u4e2d\uff0c\u65e5\u672c\u56fd\u5185 III \u671f\u4e34\u5e8a\u8bd5\u9a8c\u8fdb\u884c\u4e2d\u6216\u5df2\u5b8c\u6210\u3001\u6709\u6743\u5a01\u8bba\u6587\u53d1\u8868\u3001\u6216\u6709\u5148\u9032\u533b\u7642B \u5b9e\u65bd\u5b9e\u7ee9\u7684<\/li>\n<\/ul>\n<p>2014 \u5e74 6 \u6708\uff0c\u539a\u751f\u52b3\u52a8\u7701\u53c8\u589e\u8bbe\u4e86\u4e00\u6761\u5feb\u901f\u901a\u9053\u300c\u672a\u627f\u8a8d\u85ac\u8fc5\u901f\u5b9f\u7528\u5316\u30b9\u30ad\u30fc\u30e0\u300d\u3002\u7b2c IV \u56de\u8981\u671b\u81ea 2015 \u5e74 7 \u6708 1 \u65e5\u8d77\u968f\u65f6\u53d7\u7406\u3002\u8be5\u9875\u9762\u5217\u51fa\u7684\u6700\u8fd1\u4e00\u6b21\u4f1a\u8bae\u662f\u7b2c 68 \u56de\uff0c2026 \u5e74 5 \u6708 25 \u65e5\u53ec\u5f00\uff1b\u6b64\u524d\u56db\u6b21\u5206\u522b\u662f 2026 \u5e74 2 \u6708 6 \u65e5\u30012025 \u5e74 12 \u6708 12 \u65e5\u30012025 \u5e74 9 \u6708 29 \u65e5\u30012025 \u5e74 7 \u6708 4 \u65e5\u3002<\/p>\n<p>\u8fd9\u4e2a\u6d41\u7a0b\u7684\u7ed3\u679c\u672c\u8eab\u4e5f\u662f\u516c\u5f00\u7684\uff1a\u539a\u751f\u52b3\u52a8\u7701\u7ef4\u62a4\u7740\u4e00\u4efd\u300c\u5df2\u53d1\u51fa\u5f00\u53d1\u8981\u8bf7\u6216\u6b63\u5728\u5f81\u96c6\u5f00\u53d1\u4f01\u4e1a\u7684\u836f\u54c1\u6e05\u5355\u300d\uff0c\u6700\u540e\u66f4\u65b0\u65e5\u4e3a 2025 \u5e74 12 \u6708 15 \u65e5\u3002<\/p>\n<h2>\u5982\u679c\u4f60\u662f\u91c7\u8d2d\u65b9\uff0c\u6216\u8005\u8981\u6765\u65e5\u672c<\/h2>\n<p>\u4e0a\u9762\u8fd9\u6761\u8def\u662f\u5236\u5ea6\u6027\u7684\u3002\u5b83\u8d70\u7684\u662f\u5b66\u4f1a\u3001\u539a\u751f\u52b3\u52a8\u7701\u4e0e\u4f01\u4e1a\uff0c\u4e0d\u8d70\u4e2a\u4eba\u8d2d\u4e70\uff0c\u4e5f\u4e0d\u662f\u67d0\u4e2a\u7ecf\u9500\u5546\u63a5\u5230\u9700\u6c42\u5c31\u80fd\u8fdb\u53e3\u3002\u4e00\u4e2a\u5c1a\u672a\u901a\u8fc7\u65e5\u672c\u627f\u8a8d\u7684\u54c1\u76ee\uff0c\u4e0d\u4f1a\u56e0\u4e3a\u5728\u56fd\u5916\u83b7\u6279\u5c31\u80fd\u8fdb\u5165\u65e5\u672c\u6d41\u901a\u6e20\u9053\uff0c\u4e0d\u8bba\u533b\u7597\u4e0a\u591a\u9700\u8981\u3002<\/p>\n<p>\u5bf9\u6cd5\u4eba\u91c7\u8d2d\u65b9\u6765\u8bf4\uff0c\u53ef\u4ee5\u843d\u5730\u7684\u7ed3\u8bba\u66f4\u7a84\u4e5f\u66f4\u5b9e\u7528\uff1a\u5f53\u4e00\u4e2a\u54c1\u76ee\u51fa\u73b0\u5728\u56fd\u5916\u6279\u51c6\u540d\u5355\u4e0a\uff0c\u8be5\u5411\u65e5\u672c\u5bf9\u624b\u65b9\u95ee\u7684\u662f\u5b83\u5728\u65e5\u672c\u5904\u4e8e\u4e09\u79cd\u72b6\u6001\u4e2d\u7684\u54ea\u4e00\u79cd\u2014\u2014\u5df2\u83b7\u6279\u3001\u7533\u8bf7\u4e2d\u3001\u8fd8\u662f\u5c1a\u672a\u8fdb\u5165\u7ba1\u7ebf\u3002\u8fd9\u4e09\u4e2a\u7b54\u6848\u5bf9\u5e94\u7684\u65f6\u95f4\u8868\u5b8c\u5168\u4e0d\u540c\u3002<\/p>\n\n\n<figure class=\"wp-block-image size-full tsubaki-illustration--japan-pipeline-statuses\" data-tsubaki-illustration=\"japan-pipeline-statuses\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/japan-drug-pipeline-three-statuses.webp\" alt=\"Procurement specialists reviewing three generic status folders for approved, under-review and not-yet-filed medicines in Japan.\" class=\"wp-image-6638\" width=\"1536\" height=\"1024\" srcset=\"https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/japan-drug-pipeline-three-statuses.webp 1536w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/japan-drug-pipeline-three-statuses-300x200.webp 300w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/japan-drug-pipeline-three-statuses-1024x683.webp 1024w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/japan-drug-pipeline-three-statuses-768x512.webp 768w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/japan-drug-pipeline-three-statuses-600x400.webp 600w\" sizes=\"auto, (max-width: 1536px) 100vw, 1536px\" \/><\/figure>\n\n<h2>\u600e\u4e48\u81ea\u5df1\u67e5\u4e00\u4e2a\u5177\u4f53\u54c1\u76ee<\/h2>\n<p>\u56db\u4e2a\u516c\u5f00\u6765\u6e90\u57fa\u672c\u591f\u7528\uff0c\u800c\u4e14\u90fd\u514d\u8d39\u3002<\/p>\n<ul>\n<li><strong>FDA \u2014 Novel Drug Approvals<\/strong> \u67e5\u5e74\u5ea6\u540d\u5355\uff0cDrugs@FDA \u67e5\u5355\u4e2a\u54c1\u76ee\u7684\u6279\u51c6\u8bb0\u5f55<\/li>\n<li><strong>PMDA<\/strong> \u67e5\u65e5\u672c\u7684\u5ba1\u8bc4\u62a5\u544a\u4e0e\u627f\u8a8d\u4fe1\u606f<\/li>\n<li><strong>\u539a\u751f\u52b3\u52a8\u7701\u7684\u5f00\u53d1\u8981\u8bf7\u6e05\u5355<\/strong> \u770b\u8fd9\u4e2a\u54c1\u76ee\u662f\u5426\u5df2\u7ecf\u901a\u8fc7\u672a\u83b7\u6279\u836f\u4f1a\u8bae\u88ab\u53d7\u7406<\/li>\n<li><strong>jRCT<\/strong>\uff08\u65e5\u672c\u4e34\u5e8a\u7814\u7a76\u767b\u8bb0\u7cfb\u7edf\uff09\u770b\u65e5\u672c\u56fd\u5185\u662f\u5426\u6709\u5728\u8dd1\u7684\u7814\u7a76<\/li>\n<\/ul>\n<p>\u6bcf\u4e00\u9875\u90fd\u6807\u7740\u81ea\u5df1\u7684\u57fa\u51c6\u65e5\u3002\u4f9d\u8d56\u67d0\u4e00\u9875\u4e4b\u524d\u5148\u770b\u90a3\u4e00\u884c\u2014\u2014\u8fd9\u4e9b\u540d\u5355\u662f\u4f1a\u52a8\u7684\u3002<\/p>\n\n\n<figure class=\"wp-block-image size-full tsubaki-illustration--public-source-verification\" data-tsubaki-illustration=\"public-source-verification\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/checking-public-drug-status-sources.webp\" alt=\"Researcher comparing four public regulatory and clinical research sources with date-check notes.\" class=\"wp-image-6639\" width=\"1672\" height=\"941\" srcset=\"https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/checking-public-drug-status-sources.webp 1672w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/checking-public-drug-status-sources-300x169.webp 300w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/checking-public-drug-status-sources-1024x576.webp 1024w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/checking-public-drug-status-sources-768x432.webp 768w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/checking-public-drug-status-sources-1536x864.webp 1536w, https:\/\/tsubaki-jp.com\/wp-content\/uploads\/2026\/08\/checking-public-drug-status-sources-600x338.webp 600w\" sizes=\"auto, (max-width: 1672px) 100vw, 1672px\" \/><\/figure>\n\n<p>\u60f3\u770b\u4e00\u4e2a\u65e5\u672c\u5236\u5ea6\u540d\u5355\u5177\u4f53\u957f\u4ec0\u4e48\u6837\u3001\u8be5\u600e\u4e48\u8bfb\uff0c\u53ef\u4ee5\u53c2\u8003\u6211\u4eec\u90a3\u7bc7<a href=\"https:\/\/tsubaki-jp.com\/zh-hans\/carbon-ion-radiotherapy-advanced-medical-care-japan-zh\/\">\u5148\u9032\u533b\u7642A \u7b2c2\u53f7 \u91cd\u7c92\u5b50\u7ebf\u6cbb\u7597<\/a>\u3002\u65e5\u672c\u4fa7\u7684\u8fd1\u671f\u52a8\u6001\u89c1<a href=\"https:\/\/tsubaki-jp.com\/zh-hans\/japan-pharma-briefs-20260727-zh\/\">\u65e5\u672c\u836f\u4e8b\u7b80\u8baf<\/a>\u3002<\/p>\n<h2>\u5e38\u89c1\u95ee\u9898<\/h2>\n<h3>2026 \u5e74 7 \u6708 FDA \u6279\u4e86\u591a\u5c11\u4e2a\u65b0\u836f\uff1f<\/h3>\n<p>\u6309 FDA \u7684 Novel Drug Approvals \u9875\u9762\uff0c2026 \u5e74 7 \u6708\u5171 6 \u9879\u65b0\u836f\u83b7\u6279\u3002\u8fd9\u4e2a\u53e3\u5f84\u53ea\u7edf\u8ba1 CDER \u5ba1\u8bc4\u7684\u65b0\u5206\u5b50\u5b9e\u4f53\u4e0e\u65b0\u6cbb\u7597\u7528\u751f\u7269\u5236\u54c1\uff0c\u4e0d\u542b\u5df2\u83b7\u6279\u836f\u54c1\u7684\u9002\u5e94\u75c7\u6269\u5927\uff0c\u4e5f\u4e0d\u542b\u751f\u7269\u7c7b\u4f3c\u836f\uff0c\u6240\u4ee5\u884c\u4e1a\u5a92\u4f53\u62a5\u9053\u7684\u5f53\u6708\u603b\u6570\u901a\u5e38\u66f4\u9ad8\u3002<\/p>\n<h3>FDA \u6279\u51c6\u4e86\uff0c\u5c31\u80fd\u5728\u65e5\u672c\u9500\u552e\u5417\uff1f<\/h3>\n<p>\u4e0d\u80fd\u3002\u5728\u65e5\u672c\u4e0a\u5e02\u9700\u8981\u4f9d\u85ac\u6a5f\u6cd5\u53e6\u884c\u53d6\u5f97\u65e5\u672c\u7684\u627f\u8a8d\uff0c\u7531\u65e5\u65b9\u5bf9\u8be5\u54c1\u76ee\u81ea\u5df1\u7684\u7533\u62a5\u8d44\u6599\u5ba1\u8bc4\u3002\u56fd\u5916\u7684\u6279\u51c6\u5728\u65e5\u672c\u4e0d\u4ea7\u751f\u6548\u529b\uff0c\u4e24\u5957\u5236\u5ea6\u4e4b\u95f4\u6ca1\u6709\u81ea\u52a8\u4e92\u8ba4\u3002<\/p>\n<h3>\u628a\u6d77\u5916\u5df2\u83b7\u6279\u7684\u836f\u62ff\u5230\u65e5\u672c\u5ba1\u8bc4\uff0c\u6709\u5b98\u65b9\u9014\u5f84\u5417\uff1f<\/h3>\n<p>\u6709\u3002\u539a\u751f\u52b3\u52a8\u7701\u53ec\u96c6\u300c\u533b\u7642\u4e0a\u306e\u5fc5\u8981\u6027\u306e\u9ad8\u3044\u672a\u627f\u8a8d\u85ac\u30fb\u9069\u5fdc\u5916\u85ac\u691c\u8a0e\u4f1a\u8b70\u300d\uff0c\u7531\u5b66\u4f1a\u63d0\u51fa\u8981\u671b\uff0c\u8303\u56f4\u6db5\u76d6\u5728\u7f8e\u82f1\u5fb7\u6cd5\u52a0\u6fb3\u4efb\u4e00\u56fd\u5df2\u83b7\u6279\u7684\u836f\u54c1\u6216\u9002\u5e94\u75c7\uff1b\u8ba4\u5b9a\u533b\u7597\u5fc5\u8981\u6027\u9ad8\u7684\uff0c\u539a\u751f\u52b3\u52a8\u7701\u53ef\u5411\u4f01\u4e1a\u53d1\u51fa\u5f00\u53d1\u8981\u8bf7\uff0c\u6216\u516c\u5f00\u5f81\u96c6\u5f00\u53d1\u4f01\u4e1a\u3002<\/p>\n<h3>\u5728\u54ea\u91cc\u67e5\u4e00\u4e2a\u5177\u4f53\u836f\u54c1\u5728\u65e5\u672c\u662f\u5426\u5df2\u83b7\u6279\uff1f<\/h3>\n<p>PMDA \u516c\u5e03\u65e5\u672c\u7684\u627f\u8a8d\u4fe1\u606f\u4e0e\u5ba1\u8bc4\u62a5\u544a\uff1b\u539a\u751f\u52b3\u52a8\u7701\u53e6\u884c\u516c\u5e03\u901a\u8fc7\u672a\u83b7\u6279\u836f\u4f1a\u8bae\u53d7\u7406\u7684\u54c1\u76ee\u6e05\u5355\uff1bjRCT \u53ef\u4ee5\u67e5\u65e5\u672c\u56fd\u5185\u662f\u5426\u6709\u767b\u8bb0\u5728\u6848\u7684\u4e34\u5e8a\u7814\u7a76\u3002\u6bcf\u4e2a\u9875\u9762\u90fd\u6807\u6ce8\u81ea\u5df1\u7684\u57fa\u51c6\u65e5\uff0c\u5f15\u7528\u524d\u5148\u786e\u8ba4\u90a3\u4e00\u884c\u3002<\/p>\n<h2>\u53c2\u8003\u6765\u6e90<\/h2>\n<ul>\n<li>\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u300aNovel Drug Approvals for 2026\u300b<a href=\"https:\/\/www.fda.gov\/drugs\/novel-drug-approvals-fda\/novel-drug-approvals-2026\" rel=\"noopener\" target=\"_blank\">\u94fe\u63a5<\/a>\uff08\u7f8e\u56fd\u8054\u90a6\u653f\u5e9c\u4f5c\u54c1\uff0c\u516c\u6709\u9886\u57df\uff09<\/li>\n<li>\u539a\u751f\u52b3\u52a8\u7701\u300a\u533b\u7642\u4e0a\u306e\u5fc5\u8981\u6027\u306e\u9ad8\u3044\u672a\u627f\u8a8d\u85ac\u30fb\u9069\u5fdc\u5916\u85ac\u306e\u4eca\u5f8c\u306e\u8981\u671b\u52df\u96c6\u306b\u3064\u3044\u3066\u300b<a href=\"https:\/\/www.mhlw.go.jp\/stf\/seisakunitsuite\/bunya\/kenkou_iryou\/iyakuhin\/misyounin\/index.html\" rel=\"noopener\" target=\"_blank\">\u94fe\u63a5<\/a>\uff08\u51fa\u5178\uff1a\u539a\u751f\u52b4\u50cd\u7701\u30db\u30fc\u30e0\u30da\u30fc\u30b8\uff09<\/li>\n<li>\u539a\u751f\u52b3\u52a8\u7701\u300a\u533b\u7642\u4e0a\u306e\u5fc5\u8981\u6027\u306e\u9ad8\u3044\u672a\u627f\u8a8d\u85ac\u30fb\u9069\u5fdc\u5916\u85ac\u691c\u8a0e\u4f1a\u8b70\u300b<a href=\"https:\/\/www.mhlw.go.jp\/stf\/shingi\/other-iyaku_128701.html\" rel=\"noopener\" target=\"_blank\">\u94fe\u63a5<\/a>\uff08\u51fa\u5178\uff1a\u539a\u751f\u52b4\u50cd\u7701\u30db\u30fc\u30e0\u30da\u30fc\u30b8\uff09<\/li>\n<li>\u539a\u751f\u52b3\u52a8\u7701 \u5f00\u53d1\u8981\u8bf7\u30fb\u5f00\u53d1\u4f01\u4e1a\u5f81\u96c6\u836f\u54c1\u6e05\u5355 <a href=\"https:\/\/www.mhlw.go.jp\/stf\/seisakunitsuite\/bunya\/kenkou_iryou\/iyakuhin\/kaihatsuyousei\/index.html\" rel=\"noopener\" target=\"_blank\">\u94fe\u63a5<\/a>\uff08\u51fa\u5178\uff1a\u539a\u751f\u52b4\u50cd\u7701\u30db\u30fc\u30e0\u30da\u30fc\u30b8\uff09<\/li>\n<li>AnswersNews 2026 \u5e74 7 \u6708 FDA \u6279\u51c6\u6708\u5ea6\u6c47\u603b\uff0c2026 \u5e74 8 \u6708 7 \u65e5 <a href=\"https:\/\/answers.and-pro.jp\/pharmanews\/32994\/\" rel=\"noopener\" target=\"_blank\">\u94fe\u63a5<\/a>\u2014\u2014\u672c\u6587\u7684\u5199\u4f5c\u7531\u5934\uff0c\u672a\u590d\u8ff0\u5176\u5185\u5bb9<\/li>\n<\/ul>\n<p><small>\u672c\u6587\u4f9d\u636e\u4e0a\u5217\u6765\u6e90\u6574\u7406\u3002\u5176\u4e2d\u539a\u751f\u52b3\u52a8\u7701\u9875\u9762\u7684\u5185\u5bb9\u7ecf\u52a0\u5de5\u4f7f\u7528\uff08\u539a\u751f\u52b4\u50cd\u7701\u30db\u30fc\u30e0\u30da\u30fc\u30b8\u306e\u516c\u8868\u8cc7\u6599\u3092\u52a0\u5de5\u3057\u3066\u4f5c\u6210\uff09\u3002<\/small><\/p>\n<p><small>\u4fe1\u606f\u57fa\u51c6\u65e5\uff1a2026 \u5e74 8 \u6708 10 \u65e5\u3002FDA \u9875\u9762\u5185\u5bb9\u66f4\u65b0\u65e5\u4e3a 2026 \u5e74 8 \u6708 5 \u65e5\uff1b\u539a\u751f\u52b3\u52a8\u7701\u5f00\u53d1\u8981\u8bf7\u6e05\u5355\u6700\u540e\u66f4\u65b0\u65e5\u4e3a 2025 \u5e74 12 \u6708 15 \u65e5\u3002<\/small><\/p>\n<p><small>\u682a\u5f0f\u4f1a\u793e Tsubaki Trading \u662f\u6301\u6709\u4e1c\u4eac\u90fd\u77e5\u4e8b\u533b\u836f\u54c1\u6279\u53d1\u9500\u552e\u4e1a\u8bb8\u53ef\uff08\u7b2c5313250689\u53f7\uff09\u7684\u65e5\u672c\u6ce8\u518c\u4f01\u4e1a\uff0c\u65e5\u5e38\u76f4\u63a5\u5904\u7406\u8fd9\u4e9b\u6cd5\u89c4\u6587\u4ef6\u3002\u672c\u6587\u4ec5\u4f9b\u4fe1\u606f\u53c2\u8003\uff0c\u4e0d\u6784\u6210\u8bca\u65ad\u3001\u6cbb\u7597\u6216\u7528\u836f\u5efa\u8bae\uff0c\u4e5f\u4e0d\u662f\u5904\u65b9\u836f\u5e7f\u544a\u3002\u7f16\u8f91\u65b9\u9488\u89c1<a href=\"https:\/\/tsubaki-jp.com\/zh-hans\/editorial-policy-zh\/\">\u7f16\u8f91\u65b9\u9488\u4e0e\u533b\u836f\u4fe1\u606f\u653f\u7b56<\/a>\u3002<\/small><\/p>","protected":false},"excerpt":{"rendered":"<p>2026 \u5e74 7 \u6708 FDA \u8bb0\u5f55\u4e86 6 \u9879\u65b0\u836f\u83b7\u6279\u3002\u7f8e\u56fd\u7684\u6279\u51c6\u5728\u65e5\u672c\u4e0d\u4ea7\u751f\u6548\u529b\u2014\u2014\u672c\u6587\u8bb2\u6e05\u65e5\u672c\u628a\u6d77\u5916\u5df2\u83b7\u6279\u836f\u54c1\u7eb3\u5165\u5ba1\u8bc4\u7684\u90a3\u6761\u5b98\u65b9\u901a\u9053\u3002<\/p>\n","protected":false},"author":1,"featured_media":6634,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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