{"id":339,"date":"2026-07-05T22:48:47","date_gmt":"2026-07-05T13:48:47","guid":{"rendered":"https:\/\/koreahealthshop.com\/?p=339"},"modified":"2026-07-05T23:14:09","modified_gmt":"2026-07-05T14:14:09","slug":"mfds-ema-open-kbio-regulatory-documents-checkpoints","status":"publish","type":"post","link":"https:\/\/www.koreahealthshop.com\/en\/mfds-ema-open-kbio-regulatory-documents-checkpoints\/","title":{"rendered":"K-Bio Regulatory Data Checkpoints Through MFDS and EMA Joint Review"},"content":{"rendered":"<style>\n\/* KHS hide single post author\/category meta *\/\nbody.single-post main.wp-block-group > .wp-block-group.alignfull > .wp-block-group.has-small-font-size,\nbody.single-post .wp-block-post-featured-image + .wp-block-group.has-small-font-size {\n  display: none !important;\n}\n<\/style>\n<article>\n<section>\n<h2>\ud575\uc2ec \uc694\uc57d<\/h2>\n<p>\uc2dd\uc57d\ucc98\uac00 EMA OPEN(Opening our Procedures at EMA to Non-EU authorities) \uacf5\ub3d9\uc2ec\uc0ac\uc5d0 \ucc38\uc5ec\ud574 \ubc14\uc774\uc624\uc758\uc57d\ud488 \uad00\ub828 \uaddc\uc81c\uc790\ub8cc \uac80\ud1a0 \uacbd\ud5d8\uc744 \ucd95\uc801\ud55c \uac83\uc740 K-\ubc14\uc774\uc624 \uae30\uc5c5\uc5d0\uac8c \uc911\uc694\ud55c \uc774\uc815\ud45c\uac00 \ub420 \uac83\uc785\ub2c8\ub2e4. \uc774\ubc88 \uc774\uc288\ub294 \ud2b9\uc815 \uc81c\ud488\uc758 \ud574\uc678 \ud5c8\uac00\ub098 \uc218\ucd9c \uac00\ub2a5\uc131\uc744 \ubcf4\uc7a5\ud558\ub294 \uc758\ubbf8\uac00 \uc544\ub2c8\ub77c, \ud574\uc678 \uaddc\uc81c\uae30\uad00\uc774 \uc694\uad6c\ud558\ub294 \ud488\uc9c8\uc790\ub8cc\uc640 \ubcc0\uacbd\uad00\ub9ac \ubb38\uc11c\uc758 \uc644\uc131\ub3c4\uac00 \uc911\uc694\ud574\uc9c0\uace0 \uc788\ub2e4\ub294 \uc2e0\ud638\ub85c \ubcfc \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\uc774\ubc88 \uae00\uc5d0\uc11c\ub294 EMA OPEN \uacf5\ub3d9\uc2ec\uc0ac \uc774\uc288\ub97c \ubc14\ud0d5\uc73c\ub85c, \uaddc\uc81c\uc790\ub8cc \uc900\ube44, \ud488\uc9c8\uc790\ub8cc \uc77c\uad00\uc131, \ubcc0\uacbd\uad00\ub9ac, \ud574\uc678 \uc778\ud5c8\uac00 \ub300\uc751 \uad00\uc810\uc5d0\uc11c \uc2e4\ubb34\uc790\uac00 \ud655\uc778\ud574\uc57c \ud560 \uccb4\ud06c\ud3ec\uc778\ud2b8\ub97c \uc815\ub9ac\ud569\ub2c8\ub2e4.<\/p>\n<\/section>\n<section>\n<h2>\uc774\ubc88 \uc774\uc288\uc5d0\uc11c \ud655\uc778\ud560 \uc8fc\uc694 \ud750\ub984<\/h2>\n<p>EMA OPEN \ud504\ub85c\uadf8\ub7a8\uc740 \uc720\ub7fd\uc758\uc57d\ud488\uccad\uc774 \ube44EU \uad6d\uac00 \uaddc\uc81c\uae30\uad00\uacfc \ud611\ub825\ud574 \ud2b9\uc815 \uc758\uc57d\ud488\uc758 \uc2ec\uc0ac\u00b7\ud3c9\uac00 \uacfc\uc815\uc5d0\uc11c \uc815\ubcf4\ub97c \uad50\ud658\ud558\ub294 \uc81c\ub3c4\uc785\ub2c8\ub2e4. \uc2dd\uc57d\ucc98\uc758 \ucc38\uc5ec\ub294 \uad6d\ub0b4 \uaddc\uc81c\uae30\uad00\uc774 \uad6d\uc81c \uacf5\ub3d9\uc2ec\uc0ac \ud750\ub984 \uc548\uc5d0\uc11c \uc790\ub8cc \uac80\ud1a0 \uacbd\ud5d8\uc744 \ub113\ud788\uace0 \uc788\ub2e4\ub294 \uc810\uc5d0\uc11c \uc758\ubbf8\uac00 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\ub2e4\ub9cc \uacf5\ub3d9\uc2ec\uc0ac \ucc38\uc5ec\uac00 \uace7\ubc14\ub85c \uac1c\ubcc4 \uc81c\ud488\uc758 \ud574\uc678 \ud5c8\uac00, \uc778\uc99d, \uc218\ucd9c \uac00\ub2a5\uc131\uc744 \uc758\ubbf8\ud558\uc9c0\ub294 \uc54a\uc2b5\ub2c8\ub2e4. \uae30\uc5c5 \uc785\uc7a5\uc5d0\uc11c\ub294 \uacf5\uc2dd \ubc1c\ud45c\ub97c \uc0ac\uc5c5 \uc131\uacfc\ub85c \uacfc\uc7a5\ud558\uae30\ubcf4\ub2e4, \ud574\uc678 \uaddc\uc81c \ub300\uc751 \ubb38\uc11c\uc758 \uc815\ud569\uc131\uc744 \uc810\uac80\ud558\ub294 \uacc4\uae30\ub85c \ubcf4\ub294 \uac83\uc774 \uc548\uc804\ud569\ub2c8\ub2e4.<\/p>\n<\/section>\n<section>\n<h2>\uc8fc\uc694 \ub0b4\uc6a9 \uc815\ub9ac<\/h2>\n<p>\uc774\ubc88 \uc774\uc288\uc758 \ud575\uc2ec\uc740 \uaddc\uc81c\uae30\uad00 \uac04 \ud611\ub825\uacfc \uc790\ub8cc \uac80\ud1a0\uc758 \uacf5\ud1b5 \uae30\uc900\uc785\ub2c8\ub2e4. \ubc14\uc774\uc624\uc758\uc57d\ud488\uc774\ub098 \uc758\ub8cc\uc81c\ud488 \ubd84\uc57c\uc5d0\uc11c \ud574\uc678 \uc778\ud5c8\uac00\ub97c \uc900\ube44\ud560 \ub54c\ub294 \ud488\uc9c8\uc790\ub8cc, \uc81c\uc870\uacf5\uc815 \ubcc0\uacbd \uc774\ub825, \uadfc\uac70\uc790\ub8cc, \uc9c8\uc758\uc751\ub2f5 \uc790\ub8cc\uac00 \uc11c\ub85c \ub9de\ubb3c\ub824\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<p>\ud2b9\ud788 \ubcc0\uacbd\ud5c8\uac00, \uc81c\uc870\uacf5\uc815 \ubcc0\uacbd, \ud488\uc9c8\uad00\ub9ac \uc790\ub8cc\ub294 \uc5ec\ub7ec \uad6d\uac00\uc758 \uaddc\uc81c\uae30\uad00\uc774 \ud568\uaed8 \uac80\ud1a0\ud560 \ub54c \ub354 \uba85\ud655\ud55c \uad6c\uc870\uc640 \ucd94\uc801\uc131\uc744 \uc694\uad6c\ubc1b\uc744 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uc790\ub8cc\uac00 \ub9ce\ub2e4\ub294 \uac83\ubcf4\ub2e4 \uac19\uc740 \uc124\uba85\uc774 \uc77c\uad00\ub418\uac8c \uc720\uc9c0\ub418\ub294\uc9c0\uac00 \uc911\uc694\ud569\ub2c8\ub2e4.<\/p>\n<\/section>\n<section>\n<h2>\uc8fc\uc694 \ub0b4\uc6a9\uacfc \uc2e4\ubb34 \ud655\uc778 \ud3ec\uc778\ud2b8<\/h2>\n<table>\n<thead>\n<tr>\n<th>\uad6c\ubd84<\/th>\n<th>\uc8fc\uc694 \ub0b4\uc6a9<\/th>\n<th>\uc2e4\ubb34 \ud655\uc778 \ud3ec\uc778\ud2b8<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\uad6d\uc81c \uacf5\ub3d9\uc2ec\uc0ac<\/td>\n<td>EMA OPEN \ub4f1 \uaddc\uc81c\uae30\uad00 \uac04 \ud611\ub825 \ud750\ub984 \ud655\ub300<\/td>\n<td>\uacf5\uc2dd \ubc1c\ud45c\uc758 \uc758\ubbf8\uc640 \uc801\uc6a9 \ubc94\uc704\ub97c \uad6c\ubd84\ud574 \ud574\uc11d<\/td>\n<\/tr>\n<tr>\n<td>\uaddc\uc81c\uc790\ub8cc<\/td>\n<td>\ud488\uc9c8\uc790\ub8cc, \uc81c\uc870\uacf5\uc815, \ubcc0\uacbd\uad00\ub9ac \uc790\ub8cc\uc758 \uc911\uc694\uc131 \uc99d\uac00<\/td>\n<td>\uc790\ub8cc \uad6c\uc870, \ubc84\uc804, \uadfc\uac70\uc790\ub8cc, \uc774\ub825 \uad00\ub9ac \ud655\uc778<\/td>\n<\/tr>\n<tr>\n<td>\uc778\ud5c8\uac00 \ub300\uc751<\/td>\n<td>\uad6d\uac00\ubcc4 \uc2ec\uc0ac \uae30\uc900\uacfc \uc9c8\uc758 \ub300\uc751 \ubc29\uc2dd \ucc28\uc774 \uc874\uc7ac<\/td>\n<td>\ub300\uc0c1 \uad6d\uac00 \uae30\uc900\uacfc \uc81c\ucd9c\uc790\ub8cc \ubc94\uc704 \ubcc4\ub3c4 \ud655\uc778<\/td>\n<\/tr>\n<tr>\n<td>\ud45c\uc2dc\u00b7\uad11\uace0<\/td>\n<td>\uacf5\ub3d9\uc2ec\uc0ac \ucc38\uc5ec \uc774\uc288\ub97c \ud64d\ubcf4\uc790\ub8cc\uc5d0 \ud65c\uc6a9\ud560 \ub54c \uc8fc\uc758 \ud544\uc694<\/td>\n<td>\ud5c8\uac00\u00b7\uc778\uc99d \ubcf4\uc7a5\ucc98\ub7fc \ubcf4\uc774\ub294 \ud45c\ud604 \ubc30\uc81c<\/td>\n<\/tr>\n<tr>\n<td>\ud574\uc678\uc2dc\uc7a5<\/td>\n<td>K-\ubc14\uc774\uc624\uc758 \uaddc\uc81c \ud611\ub825 \ud750\ub984\uc744 \ubc14\uc774\uc5b4 \ub300\uc751\uc790\ub8cc\uc5d0 \ucc38\uace0 \uac00\ub2a5<\/td>\n<td>\uc218\ucd9c \uac00\ub2a5\uc131 \ub2e8\uc815 \ub300\uc2e0 \uc790\ub8cc \uc900\ube44 \uc218\uc900\uc744 \uc124\uba85<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/section>\n<section>\n<h2>\uc2e4\ubb34\uc790\uac00 \ud655\uc778\ud574\uc57c \ud560 \uccb4\ud06c\ud3ec\uc778\ud2b8<\/h2>\n<p>\uaddc\uc81c\uc790\ub8cc\ub97c \uc900\ube44\ud558\ub294 \uc2e4\ubb34\uc790\ub294 \ubc1c\ud45c \ub0b4\uc6a9 \uc790\uccb4\ubcf4\ub2e4 \ud604\uc7ac \ubcf4\uc720\ud55c \uc790\ub8cc\uac00 \ud574\uc678 \uaddc\uc81c\uae30\uad00\uc758 \uc9c8\uc758\uc5d0 \ub300\uc751\ud560 \uc218 \uc788\ub294 \uad6c\uc870\uc778\uc9c0 \ud655\uc778\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<h3>\uc2e4\ubb34\uc790\uac00 \ud655\uc778\ud574\uc57c \ud560 \uc790\ub8cc<\/h3>\n<ul>\n<li>\ud488\uc9c8\uc790\ub8cc\uc758 \ubaa9\ucc28, \ubc84\uc804, \ubcc0\uacbd \uc774\ub825, \uc791\uc131 \uae30\uc900<\/li>\n<li>\uc81c\uc870\uacf5\uc815 \ubcc0\uacbd \ub610\ub294 \ubcc0\uacbd\ud5c8\uac00 \uad00\ub828 \uadfc\uac70\uc790\ub8cc<\/li>\n<li>\uaddc\uc81c\uae30\uad00 \uc9c8\uc758\uc751\ub2f5 \uc774\ub825\uacfc \ub0b4\ubd80 \uac80\ud1a0 \uba54\ubaa8<\/li>\n<li>\ud574\uc678 \uc81c\ucd9c\uc790\ub8cc\uc640 \uad6d\ub0b4 \uc790\ub8cc \uac04 \uc6a9\uc5b4\u00b7\uc218\uce58\u00b7\uc124\uba85 \uc77c\uce58 \uc5ec\ubd80<\/li>\n<li>\ubc14\uc774\uc5b4 \ub610\ub294 \ud30c\ud2b8\ub108\uc5d0\uac8c \uc81c\uacf5\ud558\ub294 \uc694\uc57d\uc790\ub8cc\uc758 \ud45c\ud604 \uc218\uc704<\/li>\n<\/ul>\n<\/section>\n<section>\n<h2>\uc81c\ud488\uae30\ud68d\u00b7\ud45c\uc2dc\uad00\ub9ac \uad00\uc810\uc5d0\uc11c\uc758 \uc2dc\uc0ac\uc810<\/h2>\n<p>\uc81c\ud488\uae30\ud68d \ub2e8\uacc4\uc5d0\uc11c\ub294 \ud574\uc678 \uaddc\uc81c \ub300\uc751 \uac00\ub2a5\uc131\uc744 \ucd08\uae30\uc5d0 \uac80\ud1a0\ud558\ub294 \uac83\uc774 \uc911\uc694\ud569\ub2c8\ub2e4. \uc81c\ud488\uc758 \uae30\uc220\uc801 \uc7a5\uc810\ub9cc \uac15\uc870\ud558\uae30\ubcf4\ub2e4, \uc5b4\ub5a4 \uc790\ub8cc\ub85c \ud488\uc9c8\uacfc \ubcc0\uacbd\uad00\ub9ac\ub97c \uc124\uba85\ud560 \uc218 \uc788\ub294\uc9c0 \ud568\uaed8 \uc900\ube44\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<h3>\ud45c\uc2dc\u00b7\uad11\uace0 \ubb38\uad6c \uc810\uac80\uc0ac\ud56d<\/h3>\n<ul>\n<li>\uacf5\ub3d9\uc2ec\uc0ac \ucc38\uc5ec \uc0ac\uc2e4\uc744 \uac1c\ubcc4 \uc81c\ud488\uc758 \ud5c8\uac00 \ubcf4\uc7a5\ucc98\ub7fc \ud45c\ud604\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4.<\/li>\n<li>\ud574\uc678 \uc9c4\ucd9c \uac00\ub2a5\uc131\uc774\ub098 \uc218\ucd9c \uac00\ub2a5\uc131\uc744 \ub2e8\uc815\ud558\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4.<\/li>\n<li>\uc81c\ud488 \ud6a8\ub2a5, \uce58\ub8cc, \uc608\ubc29\uc744 \uc554\uc2dc\ud558\ub294 \ud45c\ud604\uc740 \uc0ac\uc6a9 \ubaa9\uc801\uacfc \uadfc\uac70\uc790\ub8cc \uae30\uc900\uc73c\ub85c \ubcc4\ub3c4 \uac80\ud1a0\ud569\ub2c8\ub2e4.<\/li>\n<li>\uaddc\uc81c\uae30\uad00 \ud611\ub825 \uc774\uc288\ub294 \uc2dc\uc7a5 \ud750\ub984 \ub610\ub294 \uc790\ub8cc \uc900\ube44 \uad00\uc810\uc5d0\uc11c \uc124\uba85\ud569\ub2c8\ub2e4.<\/li>\n<\/ul>\n<\/section>\n<section>\n<h2>\uc218\ucd9c\uc785\u00b7\ud574\uc678\uc2dc\uc7a5 \ubc0f \uc778\ud5c8\uac00 \uad00\uc810\uc5d0\uc11c\uc758 \uc2dc\uc0ac\uc810<\/h2>\n<p>\ud574\uc678\uc2dc\uc7a5 \ub300\uc751\uc5d0\uc11c\ub294 \uad6d\uac00\ubcc4 \uc790\ub8cc \uc694\uac74\uacfc \uc2ec\uc0ac \uae30\uc900\uc744 \uad6c\ubd84\ud574 \ubcf4\ub294 \uac83\uc774 \ud544\uc694\ud569\ub2c8\ub2e4. EMA OPEN \uacf5\ub3d9\uc2ec\uc0ac \uac19\uc740 \uad6d\uc81c \ud611\ub825 \ud750\ub984\uc740 \ucc38\uace0\ud560 \uc218 \uc788\uc9c0\ub9cc, \uac1c\ubcc4 \uad6d\uac00\uc758 \ud5c8\uac00 \uc694\uac74 \ucda9\uc871 \uc5ec\ubd80\ub294 \ubcc4\ub3c4\ub85c \ud655\uc778\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<h3>\ud574\uc678\uc2dc\uc7a5 \ub300\uc751 \uc2dc \ud655\uc778\uc0ac\ud56d<\/h3>\n<ul>\n<li>\ub300\uc0c1 \uad6d\uac00\ubcc4 \uc81c\ucd9c\uc790\ub8cc \ubc94\uc704\uc640 \ud615\uc2dd<\/li>\n<li>\ud488\uc9c8\uc790\ub8cc, \uc784\uc0c1 \ub610\ub294 \ube44\uc784\uc0c1 \uc790\ub8cc\uc758 \uc694\uad6c \uc218\uc900<\/li>\n<li>\ubcc0\uacbd\uad00\ub9ac \uc774\ub825\uacfc \uc81c\uc870\uacf5\uc815 \uc124\uba85\uc758 \uc77c\uad00\uc131<\/li>\n<li>\ud574\uc678 \ud30c\ud2b8\ub108\uc5d0\uac8c \uc81c\uacf5\ud558\ub294 \uc601\ubb38 \uc694\uc57d\uc790\ub8cc\uc758 \uc815\ud655\uc131<\/li>\n<li>\ud5c8\uac00 \ub610\ub294 \uc778\uc99d \uac00\ub2a5\uc131\uc744 \ubcf4\uc7a5\ud558\ub294 \ud45c\ud604\uc774 \uc5c6\ub294\uc9c0 \uc5ec\ubd80<\/li>\n<\/ul>\n<\/section>\n<section>\n<h2>KHS \ucf54\uba58\ud2b8<\/h2>\n<p>\uc774\ubc88 \uc774\uc288\ub294 K-\ubc14\uc774\uc624 \uae30\uc5c5\uc5d0\uac8c \uad6d\uc81c \uaddc\uc81c \ud611\ub825\uc758 \ud750\ub984\uc744 \ubcf4\uc5ec\uc8fc\ub294 \ub3d9\uc2dc\uc5d0, \uaddc\uc81c\uc790\ub8cc\uc758 \uae30\ubcf8\uae30\ub97c \ub2e4\uc2dc \ud655\uc778\ud558\uac8c \ud558\ub294 \uc0ac\ub840\uc785\ub2c8\ub2e4. \uacf5\ub3d9\uc2ec\uc0ac\ub77c\ub294 \ud45c\ud604\uc774 \uc8fc\ubaa9\uc744 \ub04c \uc218 \uc788\uc9c0\ub9cc, \uc2e4\ubb34\uc801\uc73c\ub85c\ub294 \ud488\uc9c8\uc790\ub8cc\uc758 \uc815\ud569\uc131, \ubcc0\uacbd\uad00\ub9ac \uc774\ub825, \uc9c8\uc758 \ub300\uc751 \uccb4\uacc4\uac00 \ub354 \uc911\uc694\ud569\ub2c8\ub2e4.<\/p>\n<p>\ud574\uc678 \ud5c8\uac00 \uac00\ub2a5\uc131\uc758 \uc2e0\ud638\ub85c \ub2e8\uc815\ud558\uae30\ubcf4\ub2e4, \ud574\uc678 \uaddc\uc81c\uae30\uad00\uacfc \uc18c\ud1b5\ud560 \uc218 \uc788\ub294 \uc790\ub8cc \uad6c\uc870\ub97c \uac16\ucd94\ub294 \uccab \uac78\uc74c\uc73c\ub85c \ubcf4\ub294 \uac83\uc774 \uc801\uc808\ud569\ub2c8\ub2e4.<\/p>\n<\/section>\n<section>\n<h2>\ucc38\uace0 \ubc0f \uc720\uc758\uc0ac\ud56d<\/h2>\n<p>\uc774 \uae00\uc740 \uc2dd\uc57d\ucc98 EMA OPEN \uacf5\ub3d9\uc2ec\uc0ac \uad00\ub828 \uc774\uc288\ub97c \ubc14\ud0d5\uc73c\ub85c \uaddc\uc81c\uc790\ub8cc\uc640 \ud574\uc678 \uc778\ud5c8\uac00 \ub300\uc751 \uad00\uc810\uc5d0\uc11c \uc815\ub9ac\ud55c \uc77c\ubc18 \uc815\ubcf4\uc785\ub2c8\ub2e4. \uac1c\ubcc4 \uc81c\ud488\uc758 \uc778\ud5c8\uac00 \uac00\ub2a5\uc131, \uc218\ucd9c\uc785 \uc808\ucc28, \ud488\uc9c8\uad00\ub9ac \uc801\uc6a9 \uc5ec\ubd80\ub294 \uc81c\ud488 \ud2b9\uc131, \ub300\uc0c1 \uad6d\uac00, \uc81c\ucd9c\uc790\ub8cc, \uad00\ub828 \ubc95\ub839\uc5d0 \ub530\ub77c \ub2ec\ub77c\uc9c8 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<p>\u203b \ubcf8 \uae00\uc740 \ud55c\uad6d OTC \uc2dc\uc7a5, \uac74\uac15\uae30\ub2a5\uc2dd\ud488, \uc758\ub8cc\uae30\uae30, \ud45c\uc2dc\u00b7\uad11\uace0, \uc218\ucd9c\uc785 \ub610\ub294 \ud488\uc9c8\uad00\ub9ac \uad00\ub828 \uc77c\ubc18 \uc815\ubcf4 \uc81c\uacf5\uc744 \ubaa9\uc801\uc73c\ub85c \uc791\uc131\ub418\uc5c8\uc2b5\ub2c8\ub2e4. \uc2e4\uc81c \uc81c\ud488\uae30\ud68d, \ud45c\uc2dc\u00b7\uad11\uace0 \uac80\ud1a0, \uc778\ud5c8\uac00 \ud310\ub2e8, \uc218\ucd9c\uc785 \uc808\ucc28 \ubc0f \ud488\uc9c8\uad00\ub9ac \uc801\uc6a9\uc740 \uad00\ub828 \ubc95\ub839\uacfc \uacf5\uc2dd \uc790\ub8cc\ub97c \uae30\uc900\uc73c\ub85c \uac1c\ubcc4 \ud655\uc778\uc774 \ud544\uc694\ud569\ub2c8\ub2e4. \ubcf8 \uae00\uc740 \uc9c8\ubcd1\uc758 \uce58\ub8cc\u00b7\uc608\ubc29 \ub610\ub294 \ud2b9\uc815 \uc81c\ud488\uc758 \ud6a8\ub2a5, \ud5c8\uac00 \ub610\ub294 \uc778\uc99d\uc744 \ubcf4\uc7a5\ud558\ub294 \ub0b4\uc6a9\uc774 \uc544\ub2d9\ub2c8\ub2e4.<\/p>\n<\/section>\n<\/article>","protected":false},"excerpt":{"rendered":"<p>Based on issues from the MFDS EMA OPEN joint review, here is a summary of regulatory documents, change management, and overseas licensing 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