{"id":39704,"date":"2025-09-05T07:12:13","date_gmt":"2025-09-04T22:12:13","guid":{"rendered":"https:\/\/www.sanctionlab.com\/?p=39704"},"modified":"2025-09-08T09:54:39","modified_gmt":"2025-09-08T00:54:39","slug":"%ec%82%bc%ec%84%b1%eb%b0%94%ec%9d%b4%ec%98%a4%ec%97%90%ed%94%bc%ec%8a%a4-%ec%8b%9c%eb%b0%80%eb%9f%ac-%ea%b7%9c%ec%a0%9c-%ec%99%84%ed%99%94-%ec%88%98%ed%98%9c%ea%b4%80%ec%84%b8%eb%8a%94","status":"publish","type":"post","link":"https:\/\/www.sanctionlab.com\/?p=39704","title":{"rendered":"\uc0bc\uc131\ubc14\uc774\uc624\uc5d0\ud53c\uc2a4, \uc2dc\ubc00\ub7ec \uaddc\uc81c \uc644\ud654 \uc218\ud61c\u2026\uad00\uc138\ub294 \uc6b0\ub824"},"content":{"rendered":"

|[\ud604\uc7a5\uc90c\u4eba]\uc9c8\ub9ac\uc5b8 \uc6b8\ub81b \uaddc\uc81c\ub2f4\ub2f9 \uc0c1\ubb34 “\ubd88\ud544\uc694\ud55c \uc784\uc0c1\uc740 \uc724\ub9ac \ubb38\uc81c, \uac01\uad6d \ub3d9\ucc38 \uc804\ub9dd”<\/h3>\n

\uc8fc\uc694 \uc120\uc9c4\uad6d\ub4e4\uc774 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uc784\uc0c1 \uac04\uc18c\ud654 \ub4f1 \uaddc\uc81c \uc644\ud654\ub97c \ucd94\uc9c4\ud558\uace0 \uc788\ub2e4. \uc0bc\uc131\ubc14\uc774\uc624\uc5d0\ud53c\uc2a4\uac00 \uc218\ud61c\ub97c \uc785\uc744 \uac83\uc774\ub77c\uace0 \uc608\uc0c1\ub418\uc9c0\ub9cc \uaddc\uc81c \ub2f9\uad6d\uc744 \uc758\uc2dd\ud558\uba70 \ud55c\ubc88\ub3c4 \uacf5\uc2dd\uc801\uc73c\ub85c \uc774\ub97c \uc5b8\uae09\ud55c \ubc14 \uc5c6\ub2e4.<\/p>\n

\uc0bc\uc131\ubc14\uc774\uc624\uc5d0\ud53c\uc2a4\uac00 \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98\uac00 \uac1c\ucd5c\ud558\ub294 \uae00\ub85c\ubc8c \ubc14\uc774\uc624 \ucf58\ud37c\ub7f0\uc2a4(GBC 2025)\uc5d0 \ucc38\uc5ec\ud574 \ucc98\uc74c\uc73c\ub85c \uc120\uc9c4\uad6d\uc758 \uaddc\uc81c \uc644\ud654\uc5d0 \ub300\ud55c \uc9c1\uc811\uc801\uc778 \uae30\ub300\uac10\uc744 \ub4dc\ub7ec\ub0c8\ub2e4. \ub2e4\ub9cc \ud2b8\ub7fc\ud504 \uad00\uc138 \uc815\ucc45\uc5d0\uc11c \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec\uac00 \ud3ec\ud568\ub420 \uac00\ub2a5\uc131\uc5d0 \ub300\ud574\uc120 \uc6b0\ub824\ub97c \ub098\ud0c0\ub0c8\ub2e4.<\/p>\n

\u25c7ICH \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uac00\uc774\ub4dc\ub77c\uc778 \uac1c\ubc1c\ub85c \uc784\uc0c1 \uac04\uc18c\ud654 \uae30\ub300<\/strong><\/p>\n

4\uc77c \uc5f4\ub9b0 \uc81c11\ud68c \uae00\ub85c\ubc8c \ubc14\uc774\uc624 \ucf58\ud37c\ub7f0\uc2a4(GBC 2025) \ud604\uc7a5\uc5d0\uc11c \ub354\ubca8\uc5d0\uc11c \ub9cc\ub09c \uc9c8\ub9ac\uc5b8 \uc6b8\ub81b \uc0bc\uc131\ubc14\uc774\uc624\uc5d0\ud53c\uc2a4 \ubbf8\uad6d \uaddc\uc81c\uc815\ucc45 \uc804\ub7b5 \ub2f4\ub2f9 \uc0c1\ubb34(\uc0ac\uc9c4<\/strong>)\ub294 “\ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uac1c\ubc1c \uc808\ucc28\ub97c \uac04\uc18c\ud654\ud558\ub294 \uac00\uc774\ub4dc\ub77c\uc778\uc774 \ub098\uc624\uba74 \uc0c1\ub2f9\ud55c \uc601\ud5a5\uc774 \uc788\uc744 \uac83”\uc774\ub77c\uace0 \ub9d0\ud588\ub2e4.<\/p>\n

\uc784\uc0c1\uc2dc\ud5d8 \uc694\uac74\uc774 \uc644\ud654\ub418\uac8c \ub418\uba74 \uac1c\ubc1c \ube44\uc6a9\uacfc \uc2dc\uac04\uc744 \ud06c\uac8c \ub2e8\ucd95\ud560 \uc218 \uc788\ub2e4. \uc8fc\uc694 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uac1c\ubc1c \uc5c5\uccb4\uc778 \uc0bc\uc131\ubc14\uc774\uc624\uc5d0\ud53c\uc2a4 \uc785\uc7a5\uc5d0\uc11c\ub294 \uacbd\uc7c1\ub825 \uac15\ud654\ub85c \uc774\uc5b4\uc9c8 \uc218 \uc788\ub2e4.<\/p>\n

\ud604\uc7ac \uc0bc\uc131\ubc14\uc774\uc624\uc5d0\ud53c\uc2a4\ub294 \ubbf8\uad6d\uacfc \uc720\ub7fd\uc5d0 \ud734\ubbf8\ub77c \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec ‘\ud558\ub4dc\ub9ac\ub9c8’, \ud5c8\uc149\ud2f4 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec ‘\uc628\ud2b8\ub8e8\uc794\ud2b8’, \uc2a4\ud154\ub77c\ub77c \uc2dc\ubc00\ub7ec ‘\ud53c\uc988\uce58\ubc14’, ‘\uc628\ubca0\ube0c\uc9c0’, \ub8e8\uc13c\ud2f0\uc2a4 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec ‘\ubc14\uc774\uc6b0\ube44\uc988’ \ub4f1\uc744 \uacf5\uae09\ud558\uace0 \uc788\ub2e4.<\/p>\n

\"\"<\/div>\n

\uc774\ub0a0 GBC 2025\uc5d0 \uc5f0\uc0ac\ub85c \ucc38\uc11d\ud55c \uc6b8\ub81b \uc0c1\ubb34\ub294 \uc0bc\uc131\ubc14\uc774\uc624\uc5d0\ud53c\uc2a4\ub97c \ub300\ud45c\ud558\ub294 \ub3d9\uc2dc\uc5d0 \uad6d\uc81c \uc81c\ub124\ub9ad\u00b7\ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uc758\uc57d\ud488 \ud611\ud68c(IGBA) \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uc704\uc6d0\ud68c \uc704\uc6d0\uc7a5 \uc790\uaca9\uc73c\ub85c \ucd08\uccad\ubc1b\uc558\ub2e4.<\/p>\n

IGBA\ub294 \uc804 \uc138\uacc4 \uc81c\ub124\ub9ad \uc758\uc57d\ud488\uacfc \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uc5c5\uccb4\ub4e4\uc758 \uc774\uc775\uc744 \ub300\ubcc0\ud558\uace0 \uaddc\uc81c \ud658\uacbd \uac1c\uc120\uc744 \uc704\ud574 \ud65c\ub3d9\ud558\ub294 \ub2e8\uccb4\ub2e4. IGBA \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uc704\uc6d0\uc7a5\uc73c\ub85c\uc11c \uae00\ub85c\ubc8c \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uaddc\uc81c \ub3d9\ud5a5\uc744 \uc9c1\uc811 \ud30c\uc545\ud558\uace0 \uc788\ub294 \uc6b8\ub81b \uc0c1\ubb34\ub294 \ucd5c\uadfc \ubcc0\ud654\ud558\ub294 \uaddc\uc81c \ud658\uacbd\uc5d0 \ub300\ud574 \uc0c1\uc138\ud788 \uc124\uba85\ud588\ub2e4.<\/p>\n

\ucd5c\uadfc \ubbf8\uad6d\uacfc \uc720\ub7fd \ub4f1 \uc8fc\uc694 \uc120\uc9c4\uad6d\uc5d0\uc11c\ub294 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uaddc\uc81c \uc644\ud654 \uc6c0\uc9c1\uc784\uc774 \ub3d9\uc2dc\ub2e4\ubc1c\uc801\uc73c\ub85c \ub098\ud0c0\ub098\uace0 \uc788\ub2e4. \uce90\ub098\ub2e4 \ubcf4\uac74\ubd80\ub294 6\uc6d4 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uc5c5\uccb4\uc5d0\uac8c \uc784\uc0c1 3\uc0c1\uc744 \ud1b5\ud55c \uc548\uc804\uc131\uacfc \ud6a8\ub2a5 \uc785\uc99d\uc744 \uc694\uad6c\ud558\uc9c0 \uc54a\uaca0\ub2e4\ub294 \uac1c\uc815\uc548\uc744 \ubc1c\ud45c\ud588\uace0 9\uc6d4 8\uc77c\uae4c\uc9c0 \uc5c5\uacc4 \uc758\uacac\uc744 \uc811\uc218\ubc1b\uace0 \uc788\ub2e4.<\/p>\n

\uc720\ub7fd\uc758\uc57d\ud488\uccad(EMA)\ub3c4 4\uc6d4 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uc2b9\uc778\uc5d0 \ud544\uc694\ud55c \uad11\ubc94\uc704\ud55c \uc784\uc0c1 \ub370\uc774\ud130 \uc591\uc744 \uc904\uc774\uace0 \uc808\ucc28\ub97c \uac04\uc18c\ud654\ud558\ub294 \uac00\uc774\ub4dc \ucd08\uc548\uc744 \ub9c8\ub828\ud588\ub2e4. \ubbf8\uad6d\uc5d0\uc11c\ub294 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uc2dc\uc7a5 \uc9c4\uc785 \uc9c0\uc5f0 \ubc29\uc9c0, \ud5c8\uac00 \uc694\uac74 \uc644\ud654, \uc0c1\ud638 \uad50\ud658\uac00\ub2a5\uc131 \uc694\uac74 \uc644\ud654 \ub4f1\uc758 \ub0b4\uc6a9\uc774 \ub2f4\uae34 \ubc95\uc548\ub4e4\uc774 \uc787\ub2ec\uc544 \ubc1c\uc758\ub410\ub2e4.<\/p>\n

\uc774\ub7ec\ud55c \uac01\uad6d\uc758 \uac1c\ubcc4\uc801\uc778 \uaddc\uc81c \uc644\ud654 \uc6c0\uc9c1\uc784\uc740 \uae00\ub85c\ubc8c \ucc28\uc6d0\uc758 \ud45c\uc900\ud654 \uc791\uc5c5\uc73c\ub85c \ubc1c\uc804\ud558\uace0 \uc788\ub2e4. \ud604\uc7ac ICH\uac00 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uac1c\ubc1c\uc744 \uc704\ud55c \uc0c8\ub85c\uc6b4 \uac00\uc774\ub4dc\ub77c\uc778\uc744 \uac1c\ubc1c\ud558\uace0 \uc788\uc73c\uba70 \ubbf8\uad6d \uc2dd\ud488\uc758\uc57d\uad6d(FDA)\uacfc EMA\uac00 \uacf5\ub3d9 \ud6c4\uc6d0\ud558\uace0 \ud55c\uad6d \uc2dd\ud488\uc758\uc57d\ud488\uc548\uc804\ucc98\ub3c4 \ud6c4\uc6d0\uae30\uad00\uc73c\ub85c \ucc38\uc5ec\ud558\uace0 \uc788\ub2e4.<\/p>\n

ICH\ub294 \uc758\uc57d\ud488 \uac1c\ubc1c\uacfc \uc2b9\uc778\uc5d0 \uad00\ud55c \uad6d\uc81c \ud45c\uc900\uacfc \uac00\uc774\ub4dc\ub77c\uc778\uc744 \uc81c\uc815\ud558\ub294 \uae30\uad6c\ub2e4. \uac01\uad6d\uc758 \uaddc\uc81c \uc694\uad6c\uc0ac\ud56d\uc744 \ud1b5\uc77c\uc2dc\ucf1c \uc911\ubcf5 \uc5f0\uad6c\ub97c \uc904\uc774\uace0 \uc2b9\uc778 \uc808\ucc28\uc758 \ud6a8\uc728\uc131\uc744 \ub192\uc774\ub294 \uc5ed\ud560\uc744 \ud55c\ub2e4. ICH\uac00 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uac1c\ubc1c \uac04\uc18c\ud654 \uac00\uc774\ub4dc\ub77c\uc778\uc744 \ud655\uc815\ud560 \uacbd\uc6b0 \ucc38\uc5ec\uad6d\ub4e4\uc740 \uc774\ub97c \uc790\uad6d \uaddc\uc81c \uc815\ucc45\uc5d0 \ubc18\uc601\ud558\uac8c \ub41c\ub2e4.<\/p>\n

\u25c7\uc784\uc0c1 \uac04\uc18c\ud654\ub85c \uacf5\ud1b5 \uc758\uacac \ucde8\ud569, \ud2b8\ub7fc\ud504 \uc815\ucc45 \ubcc0\uc218\ub294 \uc6b0\ub824<\/strong><\/p>\n

\uc6b8\ub81b \uc0c1\ubb34\ub294 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uaddc\uc81c \uc644\ud654\ub97c \uc801\uadf9 \uc9c0\uc9c0\ud558\ub294 \uc785\uc7a5\uc774\ub77c\uace0 \ubc1d\ud78c \uac00\uc6b4\ub370 \ub2e8\uc21c\ud788 \uae30\uc5c5 \uc774\uc775\ub9cc\uc744 \uc704\ud55c \uc8fc\uc7a5\uc740 \uc544\ub2c8\ub77c\ub294 \uc810\uc744 \ubd84\uba85\ud788 \ud588\ub2e4. \uc758\ub8cc \uc724\ub9ac\uc640 \uacfc\ud559\uc801 \uadfc\uac70\uc5d0 \ubc14\ud0d5\ud55c \ub17c\ub9ac\ub77c\ub294 \uc124\uba85\uc774\ub2e4.<\/p>\n

\ubc14\uc774\uc624\uc2dc\ubc00\ub7ec\uac00 \uc624\ub9ac\uc9c0\ub110 \uc758\uc57d\ud488\uacfc \ucda9\ubd84\ud788 \uc720\uc0ac\ud558\ub2e4\ub294 \uac83\uc774 \ubd84\uc11d\uc801 \uc5f0\uad6c\uc640 \uc57d\ub3d9\ud559 \uc5f0\uad6c\ub85c\ub3c4 \ucda9\ubd84\ud788 \uc99d\uba85\ud560 \uc218 \uc788\ub2e4\ub294 \uc758\uacac\uc774\ub2e4. \ub610 \uc774\ubbf8 \ud6a8\ub2a5\uc774 \uc785\uc99d\ub41c \uc624\ub9ac\uc9c0\ub110 \uc758\uc57d\ud488\uacfc \ud6a8\ub2a5 \ube44\uad50 \uc784\uc0c1 3\uc0c1\uc744 \ub2e4\uc2dc \uc218\ud589\ud558\ub294 \uac83\uc740 \uc0c8\ub85c\uc6b4 \uc758\ud559\uc801 \uc815\ubcf4\ub97c \uc81c\uacf5\ud558\uc9c0 \uc54a\ub294\ub2e4\uace0 \uc9c0\uc801\ud588\ub2e4.<\/p>\n

\ud2b9\ud788 \uc774\ubbf8 \uc54c\ub824\uc9c4 \uc0ac\uc2e4\uc744 \uc7ac\ud655\uc778\ud558\uae30 \uc704\ud574 \ud658\uc790\ub4e4\uc744 \uc784\uc0c1\uc2dc\ud5d8\uc5d0 \ucc38\uc5ec\uc2dc\ud0a4\ub294 \uac83\uc740 \ud5ec\uc2f1\ud0a4 \uc120\uc5b8\uc758 \uc758\ub8cc \uc724\ub9ac \uc6d0\uce59\uc5d0 \uc5b4\uae0b\ub09c\ub2e4\uace0 \uac15\uc870\ud588\ub2e4.<\/p>\n

\uc6b8\ub81b \uc0c1\ubb34\ub294 “\ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uac1c\ubc1c\uc5d0\uc11c \ud6a8\ub2a5 \ube44\uad50 \uc784\uc0c1\uc2dc\ud5d8\uc740 \uc0c8\ub85c\uc6b4 \uc815\ubcf4\ub97c \uc81c\uacf5\ud558\uc9c0 \uc54a\uae30 \ub54c\ubb38\uc5d0 \uc724\ub9ac\uc801 \ubb38\uc81c\ub97c \uc57c\uae30\ud55c\ub2e4”\uba70 “\uc778\uac04\uc744 \ub300\uc0c1\uc73c\ub85c \ud55c \uc2e4\ud5d8\uc774 \ud2b9\ubcc4\ud55c \uac00\uce58\ub97c \uc81c\uacf5\ud558\uc9c0 \uc54a\ub294\ub2e4\uba74 \uc2e4\ud5d8\uc744 \ud574\uc11c\ub294 \uc548 \ub41c\ub2e4”\uace0 \ub9d0\ud588\ub2e4.<\/p>\n

\uc6b8\ub81b \uc0c1\ubb34\ub294 \uc774\ubc88 GBC\uc5d0\uc11c \ud55c\uad6d \uc2dd\uc57d\ucc98\ub97c \ube44\ub86f\ud55c \uac01\uad6d \uaddc\uc81c\uae30\uad00 \uad00\uacc4\uc790\ub4e4\uacfc \ub17c\uc758\ud574 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec \uaddc\uc81c \uc644\ud654\uc5d0 \ub300\ud55c \uacf5\ud1b5\ub41c \uacfc\ud559\uc801 \uacb0\ub860\uc5d0 \ub3c4\ub2ec\ud588\ub2e4\uace0 \uc124\uba85\ud588\ub2e4. \uadf8\ub294 \ubbf8\uad6d FDA\uac00 \ud5a5\ud6c4 ICH \uac00\uc774\ub4dc\ub77c\uc778\uc744 \ud1b5\ud574 \uc774\ub7f0 \uc6c0\uc9c1\uc784\uc744 \uc120\ub3c4\ud560 \uac83\uc774\ub780 \uae30\ub300\ub97c \ub0b4\ube44\ucce4\ub2e4. \ub2e4\ub9cc \ubbf8\uad6d \ud2b8\ub7fc\ud504 \ud589\uc815\ubd80\uc758 \uc815\ucc45 \ubcc0\ud654\uc5d0 \ub300\ud574\uc11c\ub294 \uc6b0\ub824\ub97c \ud45c\ud588\ub2e4.<\/p>\n

\uc6b8\ub81b \uc0c1\ubb34\ub294 “\uc81c\ub124\ub9ad \uc758\uc57d\ud488\uc740 \uad00\uc138\uc5d0\uc11c \uba74\uc81c\ub418\ub294\ub370 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec\uac00 \ud3ec\ud568\ub420\uc9c0\ub294 \uc544\ubb34\ub3c4 \ubaa8\ub978\ub2e4”\uba70 “\uc778\ub3c4\uc758 \uacbd\uc6b0 \uad00\uc138 \ud488\ubaa9\uc5d0 \ubc14\uc774\uc624\uc2dc\ubc00\ub7ec\uac00 \ud3ec\ud568\ub418\ub294 \uac83 \uac19\uc740\ub370 \ud2b8\ub7fc\ud504 \ub300\ud1b5\ub839\uc870\ucc28 \uc774\ub7f0 \uc138\ubd80\uc0ac\ud56d\uc744 \ubaa8\ub97c \uac83\uc774\ub77c\ub294 \uac8c \ub098\uc758 \uc6b0\ub824”\ub77c\uace0 \ub9d0\ud588\ub2e4.<\/p>\n

\/ \uae40\ucc2c\ud601 \ub354\ubca8 \uae30\uc790<\/p>\n","protected":false},"excerpt":{"rendered":"

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