{"id":49569,"date":"2023-06-08T00:00:00","date_gmt":"2023-06-07T22:00:00","guid":{"rendered":"https:\/\/biorius.com\/cosmetic-news\/mocra\/"},"modified":"2024-05-08T11:43:45","modified_gmt":"2024-05-08T09:43:45","slug":"mocra","status":"publish","type":"post","link":"https:\/\/biorius.com\/ko\/cosmetic-news\/mocra\/","title":{"rendered":"MoCRA"},"content":{"rendered":"\n<div style=\"height:66px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h1 class=\"wp-block-heading\"><strong>2022\ub144 \ud654\uc7a5\ud488 \uaddc\uc81c \ud604\ub300\ud654\ubc95(MoCRA)<\/strong><\/h1>\n\n<div style=\"height:38px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p class=\"wp-block-paragraph\">2022\ub144 12\uc6d4 <sup>29\uc77c<\/sup>, \uac00\uc7a5 \uc911\uc694\ud55c \uac83\uc740 <strong>\n  <a href=\"https:\/\/mcusercontent.com\/d3d80b99002742cef41679506\/files\/6801d875-47e1-ee8d-693d-9164b7eb182a\/MOCRA.pdf\">\ud654\uc7a5\ud488 \uc694\uac74<\/a>\n<\/strong> (21 U.S.C., Sec. 321-392)\uac00 1938\ub144 \uc81c\uc815\ub41c \uc774\ub798 \uac00\uc7a5 \uc911\uc694\ud55c \uac1c\uc815\uc548\uc774 \uc2dc\ud589\ub429\ub2c8\ub2e4. \uc774 \uc0c8\ub85c\uc6b4 \ubc95\uc548\uc740 \ud654\uc7a5\ud488 \uc5c5\uacc4\uc5d0 \uc0c8\ub85c\uc6b4 \uc758\ubb34\ub97c \ub3c4\uc785\ud558\ub294 \uac83\uc73c\ub85c, \ubbf8\uad6d\uc5d0\uc11c \uc720\ud1b5\ub418\ub294 \ud654\uc7a5\ud488 \ube0c\ub79c\ub4dc\uc5d0 \uc0c1\ub2f9\ud55c \uc601\ud5a5\uc744 \ubbf8\uce60 \uac83\uc73c\ub85c \uc608\uc0c1\ub429\ub2c8\ub2e4. \uc0c8\ub85c\uc6b4 \uaddc\uc81c \uc870\ud56d\uc744 \ub118\uc5b4 MoCRA\ub294 \uc774 \uc9c0\uc5ed\uc5d0\uc11c \ud654\uc7a5\ud488 \uaddc\uc81c \ubc29\uc2dd\uc5d0 \ub300\ud55c \ud328\ub7ec\ub2e4\uc784\uc758 \ubcc0\ud654\ub85c \uac04\uc8fc\ub429\ub2c8\ub2e4. \uacf5\uc911 \ubcf4\uac74\uc744 \ubcf4\ud638\ud558\uae30 \uc704\ud574 FDA\uc5d0 \ub354 \ub9ce\uc740 \uac10\uc2dc, \uac80\uc0ac \ubc0f \uba85\ub839 \uad8c\ud55c\uc774 \ud560\ub2f9\ub429\ub2c8\ub2e4. \ub2e4\ub978 \uad8c\ud55c \uc911\uc5d0\uc11c\ub3c4 FDA\ub294 MoCRA\uc5d0 \ub530\ub77c \uc2dc\uc124\uc758 \ub4f1\ub85d\uc744 \uc911\ub2e8\ud558\uace0 \uc81c\ud488 \ub9ac\ucf5c\uc744 \uba85\ub839\ud560 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \uadf8\ub7f0 \uc758\ubbf8\uc5d0\uc11c \ubbf8\uad6d\uc758 \ud654\uc7a5\ud488 \uaddc\uc81c \ubc29\uc2dd\uc740 \uc720\ub7fd\uc758 \ubc95 \ucca0\ud559\uacfc \uc77c\uce58\ud558\ub294 \uacbd\ud5a5\uc774 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n<div class=\"wp-block-coblocks-row coblocks-row-62815184257 coblocks-animate\" data-columns=\"1\" data-layout=\"100\" data-coblocks-animation=\"fadeIn\"><div class=\"wp-block-coblocks-row__inner has-background-overlay bg-cover has-background-image bg-no-repeat bg-center-center has-background-overlay-80 has-padding has-large-padding has-margin has-small-margin is-stacked-on-mobile has-medium-gutter\" style=\"background-image:url(https:\/\/biorius.com\/wp-content\/uploads\/2023\/02\/usa.jpg)\">\n<div class=\"wp-block-coblocks-column coblocks-column-628151843613\" style=\"width:100%\"><div class=\"wp-block-coblocks-column__inner has-no-padding has-no-margin\">\n<p class=\"has-content-background-color-color has-text-color wp-block-paragraph\" style=\"font-size:22px\"><strong>\ubc14\uc774\uc624\ub9ac\uc6b0\uc2a4\ub294 \uc774\uc81c \uc774 \uc0c8\ub85c\uc6b4 \ubc95\uc548\uacfc \uad00\ub828\ub41c \ubaa8\ub4e0 \uc694\uad6c\uc5d0 \ub300\uc751\ud560 \uc218 \uc788\ub3c4\ub85d \uc644\ubcbd\ud558\uac8c \uc870\uc9c1\ub418\uc5b4 \uc788\uc73c\uba70, \ubbf8\uad6d \ub0b4 \ud654\uc7a5\ud488\uc758 \uc131\ubd84 \ubd84\uc11d\ubd80\ud130 \ubc95\uc801 \ub300\ud589\uc5d0 \uc774\ub974\ub294 &#8216;MoCRA \ud134\ud0a4 \uc194\ub8e8\uc158&#8217;\uc744 \uc5d0\uc774\uc804\ud2b8\uc778 \ubc14\uc774\uc624\ub9ac\uc6b0\uc2a4\ub97c \ud1b5\ud574 \uc81c\uacf5\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/strong><\/p>\n\n\n\n<p class=\"has-content-background-color-color has-text-color wp-block-paragraph\" style=\"font-size:22px\"><strong>15\ub144 \ub3d9\uc548 EU\uc640 \uc601\uad6d\uc5d0\uc11c \uc785\uc99d\ud55c \uac83\uacfc \ub3d9\uc77c\ud55c \ud6a8\uacfc\ub85c \ubbf8\uad6d\uc5d0\uc11c\uc758 \ud65c\ub3d9\uc744 \uc9c0\uc6d0\ud558\uaca0\uc2b5\ub2c8\ub2e4. \uc774 \uc0c8\ub85c\uc6b4 \ubc95\uc548\uc5d0 \ub300\ud574 \uad81\uae08\ud55c \uc810\uc774 \uc788\uc73c\uc2dc\uba74 \uc5b8\uc81c\ub4e0\uc9c0 \ubb38\uc758\ud574 \uc8fc\uc138\uc694.<\/strong><\/p>\n\n\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-fe48e5de wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/biorius.com\/ko\/contact\/\">\ubb38\uc758\ud558\uae30<\/a><\/div>\n<\/div>\n\n\n\n<p class=\"wp-block-paragraph\"><a id=\"_msocom_1\"><\/a><\/p>\n<\/div><\/div>\n<\/div><\/div>\n\n<div style=\"height:45px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 class=\"wp-block-heading\">\ucc45\uc784\uc790 <strong>\/ <a href=\"https:\/\/biorius.com\/cosmetics-compliance\/usa-cosmetics-regulation\/mocra\/us-agent-responsible-person\/\">\ubbf8\uad6d \ub300\ub9ac\uc778<\/a><\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\">\ubaa8\ub4e0 \ud654\uc7a5\ud488\uc5d0\ub294 604(4)\uc870\uc5d0 \uc815\uc758\ub41c \ub300\ub85c \uc9c0\uc815\ub41c \ucc45\uc784\uc790\uac00 \uc788\uc5b4\uc57c \ud558\uba70, \ucc45\uc784\uc790\ub294 \uc81c\uc870\uc5c5\uccb4, \ud3ec\uc7a5\uc5c5\uccb4 \ub610\ub294 \uc720\ud1b5\uc5c5\uccb4\uac00 \ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ucc45\uc784\uc790\uc758 \uc774\ub984\uacfc \uc8fc\uc18c\ub294 \uc81c\ud488 \ub77c\ubca8\uc5d0 \uba85\ud655\ud558\uac8c \uba85\uc2dc\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n<p class=\"wp-block-paragraph\">2023\ub144 6\uc6d4 FDA\uc5d0\uc11c \uba85\ud655\ud788 \ubc1d\ud78c \ubc14\uc640 \uac19\uc774, \ucc45\uc784\uc790\ub294 \ubbf8\uad6d \uc601\ud1a0 \ub0b4\uc5d0 \uc704\uce58\ud560 \ud544\uc694\ub294 \uc5c6\uc2b5\ub2c8\ub2e4. \ub2e8, \uc678\uad6d \ucc45\uc784\uc790\ub294 \ubc18\ub4dc\uc2dc \ubbf8\uad6d\uc5d0 \uc704\uce58\ud55c \ub300\ub9ac\uc778\uc744 \uc9c0\uc815\ud574\uc57c \ud569\ub2c8\ub2e4. \ucc45\uc784\uc790 \ubc0f \ubbf8\uad6d \ub300\ub9ac\uc778\uc758 \uc5ed\ud560\uacfc \uad00\ub828\ub41c \uc758\ubb34\uc5d0 \ub300\ud574 \uc790\uc138\ud788 \uc54c\uc544\ubcf4\ub824\uba74 <a href=\"https:\/\/biorius.com\/cosmetics-compliance\/usa-cosmetics-regulation\/mocra\/us-agent-responsible-person\/\">\uc774 \uc8fc\uc81c\uc5d0 \ub300\ud55c \ud2b9\uc815 \ud398\uc774\uc9c0\ub97c \ubc29\ubb38\ud558\uc2dc\uae30<\/a> \ubc14\ub78d\ub2c8\ub2e4.<\/p>\n\n<div class=\"wp-block-coblocks-row coblocks-row-628152634863 coblocks-animate\" data-columns=\"1\" data-layout=\"100\" data-coblocks-animation=\"fadeIn\"><div class=\"wp-block-coblocks-row__inner has-background has-text-color has-primary-color has-padding has-medium-padding has-margin has-small-margin is-stacked-on-mobile has-medium-gutter\" style=\"background-color:#e5eaee\">\n<div class=\"wp-block-coblocks-column coblocks-column-628152636393\" style=\"width:100%\"><div class=\"wp-block-coblocks-column__inner has-no-padding has-no-margin\">\n<p class=\"is-style-default has-heading-color has-text-color coblocks-animate wp-block-paragraph\" data-coblocks-animation=\"fadeIn\"><strong>\uc218\ub144\uac04 EU \ubc0f \uc601\uad6d \ucc45\uc784\uc790\ub85c \ud65c\ub3d9\ud574 \uc628 \ubc14\uc774\uc624\ub9ac\uc6b0\uc2a4\ub294 \uc774\uc81c MoCRA\uc758 \ub3c4\uc785\uc73c\ub85c \ubbf8\uad6d \ub300\ub9ac\uc778\uc73c\ub85c\uc11c \uc9c0\uc6d0\uc744 \ud655\ub300\ud560 \uc900\ube44\ub97c \ub9c8\ucce4\uc2b5\ub2c8\ub2e4.<\/strong><\/p>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/biorius.com\/ko\/contact\/\">\ubb38\uc758\ud558\uae30<\/a><\/div>\n<\/div>\n<\/div><\/div>\n<\/div><\/div>\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n<h2 class=\"wp-block-heading\"><strong>\uc2dc\uc124 \ubc0f \ud654\uc7a5\ud488 \ubaa9\ub85d \ub4f1\ub85d<\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\">607\uc870\uc5d0 \uba85\uc2dc\ub41c \ubc14\uc640 \uac19\uc774 MoCRA\ub294 \uc2dc\uc124 \ub4f1\ub85d \ubc0f \ud654\uc7a5\ud488 \ubaa9\ub85d \ub4f1\ub85d\uacfc \uac19\uc740 \ub4f1\ub85d \uc758\ubb34\ub3c4 \ud568\uaed8 \ubd80\uacfc\ud569\ub2c8\ub2e4. \uc774 \ub450 \uc791\uc5c5\uc740 \ub3d9\uc77c\ud55c \uc2dc\uc2a4\ud15c\uc744 \ud1b5\ud574 \uc218\ud589\ub418\uba70 \ub3d9\uc2dc\uc5d0 \uc218\ud589\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4 :<\/p>\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n<h3 class=\"wp-block-heading\">\uc2dc\uc124 \ub4f1\ub85d<\/h3>\n\n<div style=\"height:45px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<div class=\"wp-block-coblocks-row coblocks-row-628153211789\" data-columns=\"2\" data-layout=\"50-50\"><div class=\"wp-block-coblocks-row__inner has-no-padding has-no-margin is-stacked-on-mobile has-medium-gutter\">\n<div class=\"wp-block-coblocks-column coblocks-column-628153212954\" style=\"width:50%\"><div class=\"wp-block-coblocks-column__inner has-no-padding has-no-margin\">\n<div class=\"wp-block-coblocks-row coblocks-row-628153230875\" data-columns=\"1\" data-layout=\"100\"><div class=\"wp-block-coblocks-row__inner has-no-padding has-no-margin is-stacked-on-mobile has-medium-gutter\">\n<div class=\"wp-block-coblocks-column coblocks-column-628153232364\" style=\"width:100%\"><div class=\"wp-block-coblocks-column__inner has-no-padding has-no-margin\">\n<div class=\"wp-block-getwid-icon has-layout-framed is-aligned-center\"><div class=\"wp-block-getwid-icon__wrapper has-text-color has-primary-color\"><i class=\"fas fa-compass\"><\/i><\/div><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">\ubbf8\uad6d\uc5d0\uc11c \ud654\uc7a5\ud488\uc744 \uc81c\uc870, \uac00\uacf5 \ub610\ub294 \uc720\ud1b5\ud558\ub294 \ubaa8\ub4e0 \uc2dc\uc124\uc740 FDA\uc758 \uc804\uc6a9 IT \ud50c\ub7ab\ud3fc\uc5d0 \ub4f1\ub85d\ud558\uace0 \uc774 \ub4f1\ub85d\uc744 \ucd5c\uc2e0 \uc0c1\ud0dc\ub85c \uc720\uc9c0\ud574\uc57c \ud569\ub2c8\ub2e4(Sec. 607 (a)). \uae30\uc874 \uc2dc\uc124\uc758 \ub4f1\ub85d \uae30\ud55c\uc740 2023\ub144 12\uc6d4 <sup>29\uc77c\uae4c\uc9c0\uc785\ub2c8\ub2e4<\/sup>.<\/p>\n<\/div><\/div>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-coblocks-column coblocks-column-628153212957\" style=\"width:50%\"><div class=\"wp-block-coblocks-column__inner has-no-padding has-no-margin\">\n<div class=\"wp-block-getwid-icon has-layout-framed is-aligned-center\"><div class=\"wp-block-getwid-icon__wrapper has-text-color has-primary-color\"><i class=\"fab fa-draft2digital\"><\/i><\/div><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">\uc774\ub7ec\ud55c \uc2dc\uc124 \ub4f1\ub85d\uc740 2\ub144\ub9c8\ub2e4 \uac31\uc2e0\ud574\uc57c \ud558\uba70, \uc2e0\uaddc \uc2dc\uc124\uc740 \ucc98\uc74c \ud65c\ub3d9\uc744 \uc2dc\uc791\ud55c \ud6c4 60\uc77c \uc774\ub0b4(\ub610\ub294 2023\ub144 12\uc6d4 <sup>29\uc77c\uc5d0<\/sup> \uc885\ub8cc\ub418\ub294 \ucd5c\ucd08 \uc804\ud658 \uae30\uac04 \uc774\ud6c4 60\uc77c \uc774\ub0b4)\uc5d0 \ub4f1\ub85d\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<\/div><\/div>\n<\/div><\/div>\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n<h3 class=\"wp-block-heading\">\ud654\uc7a5\ud488 \uc81c\ud488 \ubaa9\ub85d<\/h3>\n\n<div style=\"height:45px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<div class=\"wp-block-columns are-vertically-aligned-center is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"wp-block-coblocks-row alignfull coblocks-row-628153742576\" data-columns=\"1\" data-layout=\"100\"><div class=\"wp-block-coblocks-row__inner has-no-padding has-no-margin is-stacked-on-mobile has-medium-gutter\">\n<div class=\"wp-block-coblocks-column coblocks-column-628153744125\" style=\"width:100%\"><div class=\"wp-block-coblocks-column__inner has-no-padding has-no-margin\">\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"wp-block-getwid-icon has-layout-framed is-aligned-center\"><div class=\"wp-block-getwid-icon__wrapper has-text-color has-primary-color\"><i class=\"far fa-list-alt\"><\/i><\/div><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">\ucc45\uc784\uc790\ub294 \uc2dc\ud310 \uc911\uc778 \ud654\uc7a5\ud488\uc5d0 \ub300\ud55c \ucd5c\uc2e0 \ub9ac\uc2a4\ud305\uc744 \ub9e4\ub144 FDA\uc5d0 \uc720\uc9c0\ud574\uc57c \ud569\ub2c8\ub2e4. \ubaa9\ub85d\uc5d0\ub294 \uc81c\ud488 \uc774\ub984, \uc720\ud615 \ubc0f \uc131\ubd84\uacfc \uac19\uc740 \uc138\ubd80 \uc815\ubcf4\uac00 \ud3ec\ud568\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4. \ud654\uc7a5\ud488 \ub9ac\uc2a4\ud305 \uae30\ud55c\uc740 2023\ub144 12\uc6d4 <sup>29\uc77c\uae4c\uc9c0\uc774\uba70<\/sup>, \uc2e0\uaddc \ud654\uc7a5\ud488\uc740 \uc8fc \uac04 \uc0c1\uac70\ub798\uc5d0\uc11c \ud310\ub9e4\ub41c \ud6c4 120\uc77c \uc774\ub0b4\uc5d0 \ub9ac\uc2a4\ud305\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"wp-block-getwid-icon has-layout-framed is-aligned-center\"><div class=\"wp-block-getwid-icon__wrapper has-text-color has-primary-color\"><i class=\"fas fa-compass\"><\/i><\/div><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">\uc2dc\uc124 \ub4f1\ub85d\uacfc \ub9c8\ucc2c\uac00\uc9c0\ub85c \ud654\uc7a5\ud488 \ub4f1\ub85d\uc740 FDA\uc5d0\uc11c \uc81c\uacf5\ud558\ub294 IT \ud50c\ub7ab\ud3fc(\uc544\uc9c1 \ubbf8\uc815)\uc744 \ud1b5\ud574 \uc774\ub8e8\uc5b4\uc9c8 \uc608\uc815\uc785\ub2c8\ub2e4. \uc774 \ud50c\ub7ab\ud3fc\uc740 2023\ub144 3\uc6d4 <sup>27\uc77c\uc5d0<\/sup> \ube44\ud65c\uc131\ud654\ub41c \uae30\uc874 \uc790\ubc1c\uc801 \ud654\uc7a5\ud488 \ub4f1\ub85d \ud504\ub85c\uadf8\ub7a8(VCRP) \uc804\uc6a9 \ud50c\ub7ab\ud3fc\uc744 \uae30\ubc18\uc73c\ub85c \uac1c\ubc1c\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4. \ud558\uc9c0\ub9cc \uc774 VCRP \ub370\uc774\ud130\ubca0\uc774\uc2a4\ub294 \uc0c8 \uc2dc\uc2a4\ud15c\uc73c\ub85c \ub9c8\uc774\uadf8\ub808\uc774\uc158\ub418\uc9c0 \uc54a\uace0 FDA\uc5d0 \ubcf4\uad00\ub420 \uac83\uc73c\ub85c \uc54c\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"wp-block-getwid-icon has-layout-framed is-aligned-center\"><div class=\"wp-block-getwid-icon__wrapper has-text-color has-primary-color\"><i class=\"fas fa-project-diagram\"><\/i><\/div><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">\ud654\uc7a5\ud488\uc5d0 \ub300\ud55c \ub2e8\uc77c \ubaa9\ub85d \uc81c\ucd9c\uc5d0\ub294 \ub3d9\uc77c\ud55c \uc81c\ud615\uc758 \uc5ec\ub7ec \ud654\uc7a5\ud488 \ub610\ub294 \uc0c9\uc0c1, \ud5a5 \ub610\ub294 \ud5a5\ub8cc \ub610\ub294 \ub0b4\uc6a9\ubb3c\uc758 \uc591\ub9cc \ub2e4\ub978 \uc81c\ud615\uc774 \ud3ec\ud568\ub420 \uc218 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<\/div>\n<\/div>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\uc548\uc804\uc131 \uc785\uc99d<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">MoCRA\ub294 608\uc870\uc5d0 \ud654\uc7a5\ud488 \ucc45\uc784\uc790\ub294 \uc81c\ud488\uc758 \uc548\uc804\uc131\uc744 \uc801\uc808\ud788 \uc785\uc99d\ud560 \uc218 \uc788\ub294 \uae30\ub85d\uc744 \ud655\ubcf4\ud558\uace0 \uc720\uc9c0\ud574\uc57c \ud55c\ub2e4\uace0 \uaddc\uc815\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\uac1c\uc815\uc548\uc740 \ud654\uc7a5\ud488\uc758 \uc548\uc804\uc131\uc744 \uc801\uc808\ud788 \uc785\uc99d\ud558\ub294 \ubc29\ubc95\uc5d0 \ub300\ud574 \uaddc\ubc94\uc801\uc774\uc9c0 \uc54a\uc9c0\ub9cc \ub2e4\uc74c\uacfc \uac19\uc774 \uba85\uc2dc\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<em>\ud654\uc7a5\ud488 \ubc0f \uadf8 \uc131\ubd84\uc758 \uc548\uc804\uc131\uc744 \ud3c9\uac00\ud560 \uc218 \uc788\ub294 \uacfc\ud559\uc801 \ud6c8\ub828\uacfc \uacbd\ud5d8\uc744 \uac16\ucd98 \uc804\ubb38\uac00\uac00 \ud654\uc7a5\ud488\uc774 \uc548\uc804\ud558\ub2e4\ub294 \ud569\ub9ac\uc801\uc778 \ud655\uc2e0\uc744 \ub4b7\ubc1b\uce68\ud558\uae30\uc5d0 \ucda9\ubd84\ud55c \uc2dc\ud5d8 \ub610\ub294 \uc5f0\uad6c, \uc870\uc0ac, \ubd84\uc11d \ub610\ub294 \uae30\ud0c0 \uc99d\uac70 \ub610\ub294 \uc815\ubcf4.<\/em>&#8220;.<\/p>\n\n\n\n<p class=\"is-style-info wp-block-paragraph\">\uc774\ub7ec\ud55c \uadfc\uac70\uc640 \uad00\ub828 \ubb34\uc5ed \ud611\ud68c\uc640\uc758 \ucd94\uac00 \ub17c\uc758\ub97c \ud1b5\ud574 \ubc14\uc774\uc624\ub9ac\uc6b0\uc2a4\ub294 \uc720\ub7fd \ud654\uc7a5\ud488 \uaddc\uc815 EC No 1223\/2009\uc5d0 \ub530\ub77c \uc791\uc131\ub41c \ud654\uc7a5\ud488 \uc548\uc804\uc131 \ubcf4\uace0\uc11c(CPSR)\uac00 \ubbf8\uad6d\uc5d0\uc11c \ud654\uc7a5\ud488\uc758 \uc548\uc804\uc131\uc744 \uc801\uc808\ud788 \uc785\uc99d\ud558\ub294 \ub370 \ucda9\ubd84\ud558\ub2e4\uace0 \ud310\ub2e8\ud569\ub2c8\ub2e4. EU \ub610\ub294 \uc601\uad6d\uc5d0\uc11c \ud310\ub9e4\ub418\uc9c0 \uc54a\ub294 \ud654\uc7a5\ud488\uc740 CPSR\uacfc \ub3d9\uc77c\ud55c \ubaa9\uc801\uc73c\ub85c \ub3c5\uc131\ud559\uc801 \uc704\ud5d8 \ud3c9\uac00\uac00 \ud544\uc694\ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ub9c8\uc9c0\ub9c9\uc73c\ub85c, \uc139\uc158 614(a)\ub294 \uc5b4\ub5a4 \uc8fc\uc5d0\uc11c\ub3c4 \ud654\uc7a5\ud488\uc758 \uc548\uc804\uc131 \uc785\uc99d\uc5d0 \uad00\ud55c \ubc95\ub960\uc774\ub098 \uaddc\uc815\uc744 \uc81c\uc815\ud558\uac70\ub098 \uacc4\uc18d \uc2dc\ud589\ud560 \uc218 \uc5c6\uc73c\uba70, \uc774\ub294 MoCRA\uc5d0 \uc801\uc6a9\ub418\ub294 \uc694\uac74\uacfc &#8220;\ub2e4\ub974\uac70\ub098 \ucd94\uac00\ub418\uac70\ub098 \ub3d9\uc77c\ud558\uc9c0 \uc54a\uc740&#8221; \uc694\uac74\uc774\ub77c\uace0 \uba85\uc2dc\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\ub808\uc774\ube14\uc744 \uc9c0\uc815\ud574\uc57c \ud558\ub294 \ud544\uc218 \uc694\uc18c<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">MoCRA\uc758 609\uc870\ub294 \uc0c8\ub85c\uc6b4 \ub77c\ubca8\ub9c1 \uc694\uad6c \uc0ac\ud56d\uc744 \ub9cc\ub4ed\ub2c8\ub2e4. \uc774\ub7ec\ud55c \uaddc\uc815\uc758 \uc2dc\ud589\uc740 21 U.S.C., Sec. 321-392(FD&amp;C\ubc95, 21 C.F.R., Sec. 700-740\uc5d0 \ub530\ub77c \uc2dc\ud589) \ubc0f 15 U.S.C., Sec. 1451-1460(\uacf5\uc815 \ud3ec\uc7a5 \ubc0f \ud45c\uc2dc\ubc95, 16 C.F.R., Sec. 500-503\uc5d0 \ub530\ub77c \uc2dc\ud589)\uc5d0 \uc608\uc2dc\ub41c \uc77c\ubc18\uc801\uc778 \ud45c\uc2dc \uc694\uac74\uc5d0 \ub300\ud55c \uce68\ud574 \uc5c6\uc774 \uc774\ub8e8\uc5b4\uc9d1\ub2c8\ub2e4.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uc774\ub7ec\ud55c \uc0c8\ub85c\uc6b4 \ub77c\ubca8\ub9c1 \uc694\uac74\uc5d0\ub294 \ucc45\uc784\uc790(\ub610\ub294 \ubbf8\uad6d \ub300\ub9ac\uc778)\uac00 \ubd80\uc791\uc6a9 \ubcf4\uace0\ub97c \ubc1b\uc744 \uc218 \uc788\ub294 \uad6d\ub0b4 \uc8fc\uc18c, \uc804\ud654\ubc88\ud638 \ub610\ub294 \uc804\uc790 \uc5f0\ub77d\ucc98 \uc815\ubcf4\uac00 \ud3ec\ud568\ub429\ub2c8\ub2e4. \uc774 \ub77c\ubca8\ub9c1 \uc694\uac74\uc744 \uc900\uc218\ud558\uae30 \uc704\ud55c \uc804\ud658 \uae30\uac04\uc740 2\ub144\uc73c\ub85c, \ubbf8\uad6d \uc2dc\uc7a5\uc5d0 \ucd9c\uc2dc\ub418\ub294 \ud654\uc7a5\ud488\uc758 \ud3ec\uc7a5\uc740 2024\ub144 12\uc6d4 29\uc77c\uae4c\uc9c0 \ubcc0\uacbd\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>FDA\uc5d0\uc11c \uc2dd\ubcc4\ud558\ub294 \ud5a5\ub8cc \uc54c\ub808\ub974\uae30 \uc720\ubc1c \ubb3c\uc9c8\uc744 \uacf5\uac1c\ud569\ub2c8\ub2e4. FDA\ub294 2024\ub144 5\uc6d4 <sup>29\uc77c\uae4c\uc9c0<\/sup> \uacf5\uac1c\ud560 \ud5a5\ub8cc \uc54c\ub808\ub974\uae30 \uc720\ubc1c \ubb3c\uc9c8\uc744 \ud30c\uc545\ud558\uace0, \uc81c\uc548\ub41c \uaddc\uce59 \uc81c\uc815\uc5d0 \ub300\ud55c \uacf5\uac1c \uc758\uacac \uc218\ub834 \uae30\uac04\uc774 \ub9c8\uac10\ub41c \ub0a0\ub85c\ubd80\ud130 180\uc77c \uc774\ub0b4\uc5d0 \ucd5c\uc885 \uaddc\uce59 \uc81c\uc815\uc744 \ubc1c\ud45c\ud574\uc57c \ud569\ub2c8\ub2e4.<\/li>\n\n\n\n<li>\uc804\ubb38\uac00\ub9cc \uc0ac\uc6a9\ud560 \uc218 \uc788\ub294 \uc81c\ud488\uc5d0 \ub300\ud574 \uba85\ud655\ud558\uace0 \ub208\uc5d0 \uc798 \ub744\ub294 \ub77c\ubca8\uc744 \ubd80\ucc29\ud558\uc5ec \uba74\ud5c8\ub97c \uc18c\uc9c0\ud55c \uc804\ubb38\uac00\uac00 \uad00\ub9ac\ud558\uac70\ub098 \uc0ac\uc6a9\ud574\uc57c \ud568\uc744 \ud45c\uc2dc\ud558\uace0 \uc774\uc640 \uad00\ub828\ud558\uc5ec \uc81c\uc815\ub41c FDA \uc694\uac74\uc744 \uc900\uc218\ud558\ub294\uc9c0 \ud655\uc778\ud569\ub2c8\ub2e4. \uc774 \ub77c\ubca8\ub9c1 \uc694\uac74\uc740 2023\ub144 12\uc6d4 <sup>29\uc77c\ubd80\ud130<\/sup> \uc801\uc6a9\ub420 \uc608\uc815\uc785\ub2c8\ub2e4.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">614 (b)\ud56d\uc5d0 \ubcf4\uace0\ub41c \ubc14\uc640 \uac19\uc774, MoCRA\ub294 \ud654\uc7a5\ud488 \uc131\ubd84\uc5d0 \ub300\ud55c \uc8fc\uc815\ubd80 \ubcf4\uace0\uc5d0 \ub300\ud574 \ubc95 \uc81c\uc815 \ub2f9\uc2dc \uc2dc\ud589 \uc911\uc778 \uc8fc\uc815\ubd80\uc758 \uc694\uac74\uc744 \uc5b4\ub5a4 \uc8fc\uc5d0\uc11c\ub3c4 \uacc4\uc18d \uc2dc\ud589\ud558\ub294 \uac83\uc744 \ub9c9\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4. \uc989, Prop. \uce98\ub9ac\ud3ec\ub2c8\uc544\uc758 65\ub294 \uc5ec\uc804\ud788 \uc644\uc804\ud788 \uc801\uc6a9\ub429\ub2c8\ub2e4.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\uc7ac\ub8cc<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<h3 class=\"wp-block-heading has-primary-color has-text-color\">\ud65c\uc11d(Sec. 3504)<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\ud0c8\ud06c \ud568\uc720 \ud654\uc7a5\ud488\uc758 \uc11d\uba74 \uac80\ucd9c \ubc0f \uc2dd\ubcc4\uc744 \uc704\ud55c \ud45c\uc900\ud654\ub41c \ud14c\uc2a4\ud2b8 \ubc29\ubc95\uc740 MoCRA \uc81c\uc815 \ud6c4 1\ub144 \uc774\ub0b4(2023\ub144 12\uc6d4 <sup>29\uc77c<\/sup>)\uc5d0 FDA\uc5d0\uc11c \ucd08\uc548\uc744 \ub9c8\ub828\ud574\uc57c \ud569\ub2c8\ub2e4. \ud45c\uc900\ud654\ub41c \ubc29\ubc95\uc744 \ubcf4\uace0\ud558\ub294 \ucd5c\uc885 \uaddc\uc815\uc740 \uc81c\uc548\ub41c \uaddc\uc815\uc5d0 \ub300\ud55c \uacf5\uac1c \uc758\uacac \uc218\ub834 \uae30\uac04\uc774 \ub9c8\uac10\ub41c \ub0a0\ub85c\ubd80\ud130 180\uc77c \uc774\ub0b4\uc5d0 \ucc44\ud0dd\ub420 \uc608\uc815\uc785\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<h3 class=\"wp-block-heading has-primary-color has-text-color\">PFAS [Perfluoroalkyl and Polyfloroalkyl substances] (Sec. 3506)<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">FDA\ub294 \uad00\ub828 \uc704\ud5d8\uc744 \ud3ec\ud568\ud558\uc5ec \ud654\uc7a5\ud488\uc5d0\uc11c \ud37c\ud50c\ub8e8\uc624\ub85c\uc54c\ud0ac \ubc0f \ud3f4\ub9ac\ud50c\ub8e8\uc624\ub85c\uc54c\ud0ac \ubb3c\uc9c8\uc758 \uc0ac\uc6a9 \ubc0f \uc548\uc804\uc131\uc744 \ud3c9\uac00\ud574\uc57c \ud569\ub2c8\ub2e4. \ud3c9\uac00 \uacb0\uacfc\ub97c \uc694\uc57d\ud55c \ubcf4\uace0\uc11c\ub294 \ubc95 \uc81c\uc815 \ud6c4 3\ub144 \uc774\ub0b4\uc5d0 FDA \uc6f9\uc0ac\uc774\ud2b8\uc5d0 \uac8c\uc2dc\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<h3 class=\"wp-block-heading has-primary-color has-text-color\">\uc81c\ud55c \uc5c6\uc74c<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">614\uc870 (b)\ud56d\uc740 MoCRA\uac00 \uc5b4\ub5a4 \uc8fc\uc5d0\uc11c\ub3c4 \ud654\uc7a5\ud488 \uc131\ubd84\uc758 \uc591\uc744 \uc81c\ud55c\ud558\ub294 \uc0ac\uc6a9\uc744 \uae08\uc9c0\ud558\ub294 \uac83\uc744 \uae08\uc9c0\ud558\uc9c0 \uc54a\ub294\ub2e4\uace0 \uaddc\uc815\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4. \ub530\ub77c\uc11c \uad6d\uac00 \uc870\ud56d\uc740 \uc5ec\uc804\ud788 \uc644\uc804\ud788 \uc801\uc6a9\ub429\ub2c8\ub2e4.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\ubd80\uc791\uc6a9  <\/h2>\n\n\n\n<div style=\"height:45px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\"><div class=\"wp-block-coblocks-icon has-text-align-center is-style-filled\">\n\t\t\t\t<div class=\"wp-block-coblocks-icon__inner has-text-color has-primary-color\" style=\"height: 60px; width: 60px;\">\n\t\t\t\t\t<svg fill=\"none\" viewBox=\"0 0 20 20\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"m20.0286458 10.0068123-2.2181818-2.52727276.3090909-3.34545455-3.2818182-.74545454-1.7181818-2.8909091-3.0909091 1.32727273-3.09090906-1.32727273-1.71818182 2.8909091-3.28181818.73636363.30909091 3.34545455-2.21818182 2.53636367 2.21818182 2.5272727-.30909091 3.3545454 3.28181818.7454546 1.71818182 2.8909091 3.09090906-1.3363637 3.0909091 1.3272728 1.7181818-2.8909091 3.2818182-.7454546-.3090909-3.3454545zm-9.0909091 4.5454545h-1.81818178v-1.8181818h1.81818178zm0-3.6363636h-1.81818178v-5.45454548h1.81818178z\" fill=\"currentColor\" \/><\/svg>\n\t\t\t\t<\/div>\n\t\t\t<\/div><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<p class=\"is-style-warning wp-block-paragraph\">\uc81c605\uc870\ub294 \ubd80\uc791\uc6a9 \ubcf4\uace0 \ubc0f \uad00\ub9ac\uc640 \uad00\ub828\ud558\uc5ec \ucc45\uc784\uc790\uc5d0\uac8c \uc911\uc694\ud55c \uc758\ubb34\ub97c \uaddc\uc815\ud558\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\">\n<div class=\"wp-block-getwid-icon is-aligned-center\"><div class=\"wp-block-getwid-icon__wrapper has-text-color has-primary-color\" style=\"font-size:50px\"><i class=\"fas fa-shuttle-van\"><\/i><\/div><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<p class=\"is-style-warning wp-block-paragraph\">\uc911\ub300\ud55c \ubd80\uc791\uc6a9(\uc0ac\ub9dd, \uc0dd\uba85\uc744 \uc704\ud611\ud558\ub294 \uacbd\ud5d8, \uc785\uc6d0, \uc9c0\uc18d\uc801\uc774\uac70\ub098 \uc2ec\uac01\ud55c \uc7a5\uc560 \ub610\ub294 \ubb34\ub2a5\ub825, \uc120\ucc9c\uc801 \uae30\ud615 \ub610\ub294 \uc120\ucc9c\uc801 \uacb0\ud568, \uac10\uc5fc, \ud569\ub9ac\uc801\uc73c\ub85c \uc608\uce21 \uac00\ub2a5\ud55c \uc0ac\uc6a9 \uc870\uac74\uc5d0\uc11c \uc758\ub3c4\ud55c \uac83\uacfc \ub2e4\ub978 \uc911\ub300\ud55c \uc7a5\uc560\ub97c \ucd08\ub798\ud558\uac70\ub098 \uadf8\ub7ec\ud55c \uacb0\uacfc\ub97c \ubc29\uc9c0\ud558\uae30 \uc704\ud574 \uc758\ub8cc\uc801 \uac1c\uc785\uc774 \ud544\uc694\ud55c \ubd80\uc791\uc6a9\uc73c\ub85c \uc815\uc758)\uc740 15\uc77c \uc774\ub0b4\uc5d0 FDA\uc5d0 \ubcf4\uace0\ud574\uc57c \ud569\ub2c8\ub2e4.<\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\"><div class=\"wp-block-coblocks-icon has-text-align-center\">\n\t\t\t\t<div class=\"wp-block-coblocks-icon__inner has-text-color has-primary-color\" style=\"height: 60px; width: 60px;\">\n\t\t\t\t\t<svg fill=\"none\" viewBox=\"0 0 20 20\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"m19.9986483 8.20489366h-7.5333334l3.0444445-3.13333333c-3.0333334-3-7.94444447-3.11111111-10.97777781-.11111111-3.03333333 3.01111111-3.03333333 7.86666668 0 10.87777778 3.03333334 3.0111111 7.94444441 3.0111111 10.97777781 0 1.5111111-1.4888889 2.2666666-3.2333333 2.2666666-5.4333333h2.2222223c0 2.2-.9777778 5.0555555-2.9333334 6.9888889-3.9 3.8666666-10.23333331 3.8666666-14.13333331 0-3.88888889-3.8555556-3.92222222-10.12222227-.02222222-13.97777783 3.9-3.85555555 10.15555553-3.85555555 14.05555553 0l3.0333334-3.12222222zm-9.4444445-2.35555555v4.72222219l3.8888889 2.3111111-.8 1.3444445-4.75555555-2.8222222v-5.55555559z\" transform=\"translate(0 -.293783)\" fill=\"currentColor\" \/><\/svg>\n\t\t\t\t<\/div>\n\t\t\t<\/div><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<p class=\"is-style-warning wp-block-paragraph\">\ubd80\uc791\uc6a9\uc740 \ucc45\uc784\uc790\uac00 \uae30\ub85d\ud574\uc57c \ud558\uba70, \uc0ac\uc5c5 \uaddc\ubaa8\uc5d0 \ub530\ub77c \ucd5c\uc18c 3\ub144\uc5d0\uc11c \ucd5c\ub300 6\ub144 \ub3d9\uc548 \ubcf4\uad00\ud574\uc57c \ud569\ub2c8\ub2e4. FDA\ub294 \ub2e4\ub978 \uc0c8\ub85c\uc6b4 \uc758\ubb34 \uc911\uc5d0\uc11c\ub3c4 \uc774\ub7ec\ud55c \uae30\ub85d\uc744 \uc870\uc0ac\ud560 \uad8c\ub9ac\uac00 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n<\/div>\n<\/div>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\uc6b0\uc218 \uc81c\uc870 \uad00\ud589<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">MoCRA\ub294 606\uc870\ub97c \ud1b5\ud574 <a href=\"https:\/\/biorius.com\/regulatory\/gmp-good-manufacturing-practices\/\">\uc6b0\uc218 \uc81c\uc870 \uad00\ub9ac \uae30\uc900<\/a> (GMP) \uc900\uc218 \uc758\ubb34\ub3c4 \ub3c4\uc785\ud588\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\ud654\uc7a5\ud488\uc774 \ubd88\uc21c\ubb3c\uc774 \uc11e\uc774\uc9c0 \uc54a\uc558\ub294\uc9c0 \ud655\uc778\ud569\ub2c8\ub2e4. \uc774\ub7ec\ud55c \ud2b9\uc815 GMP \uc694\uac74\uc5d0 \ub300\ud55c \ucd08\uc548\uc740 MoCRA \uc81c\uc815\uc77c(2022\ub144 12\uc6d4 <sup>29\uc77c<\/sup>)\ub85c\ubd80\ud130 2\ub144 \uc774\ub0b4\uc5d0 FDA\uc5d0\uc11c \ubc1c\ud45c\ud558\uba70, \ub2a6\uc5b4\ub3c4 \uc81c\uc815\uc77c\ub85c\ubd80\ud130 3\ub144 \uc774\ub0b4\uc5d0 \ucd5c\uc885 \ud655\uc815\ub420 \uc218 \uc788\ub3c4\ub85d \uace0\ub824\ud574\uc57c \ud569\ub2c8\ub2e4. \ud604 \ub2e8\uacc4\uc5d0\uc11c\ub294 \uc774\ub7ec\ud55c GMP \uc694\uac74\uc774 \uc2e4\ud589 \uac00\ub2a5\ud55c \ubc94\uc704 \ub0b4\uc5d0\uc11c \uad6d\ub0b4 \ubc0f \uad6d\uc81c \ud45c\uc900\uc5d0 \ubd80\ud569\ud574\uc57c \ud55c\ub2e4\ub294 \uac83\ub9cc \uc54c\uace0 \uc788\uc2b5\ub2c8\ub2e4.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">FDA\ub294 \ud654\uc7a5\ud488 \uc81c\uc870\uc5d0 \uad00\uc5ec\ud558\ub294 \uc2dc\uc124\uc758 \uae30\ub85d\uc744 \uac80\uc0ac\ud558\uace0 \uc774\ub7ec\ud55c GMP\ub97c \uc900\uc218\ud558\ub294\uc9c0 \ud655\uc778\ud560 \uc218 \uc788\ub294 \uad8c\ud55c\uc744 \uac16\uac8c \ub429\ub2c8\ub2e4. \ud558\uc9c0\ub9cc \uaddc\uc81c \ub2f9\uad6d\uc740 FDA\uc5d0 \uc18c\uaddc\ubaa8 \ube44\uc988\ub2c8\uc2a4\uc758 \ud2b9\uc815 \uc81c\uc57d \uc870\uac74\uc5d0 \ub9de\uac8c \uc694\uad6c \uc0ac\ud56d\uc744 \uc870\uc815\ud560 \uac83\uc744 \uc694\uad6c\ud588\uc2b5\ub2c8\ub2e4.<\/p>\n<\/div>\n<\/div>\n\n<h2 class=\"wp-block-heading\"><strong>\ud0c0\uc784\ub77c\uc778<\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\">\uc774\ub7ec\ud55c \ubcc0\uacbd \uc0ac\ud56d\uc774 \ubaa8\ub450 \ub3d9\uc2dc\uc5d0 \uc801\uc6a9\ub418\ub294 \uac83\uc740 \uc544\ub2c8\ubbc0\ub85c \ub2e4\uc74c \ub2e8\uacc4\uc640 \uaddc\uc815 \uc900\uc218\uc5d0 \ub300\ud55c \uc694\uc57d\uc740 \ub2e4\uc74c\uacfc \uac19\uc2b5\ub2c8\ub2e4:<\/p>\n\n<div class=\"wp-block-getwid-content-timeline is-animated\" data-filling=\"true\"><div class=\"wp-block-getwid-content-timeline__line\"><div class=\"wp-block-getwid-content-timeline__bar\"><\/div><\/div><div class=\"wp-block-getwid-content-timeline__wrapper\">\n<div class=\"wp-block-getwid-content-timeline-item\"><div class=\"wp-block-getwid-content-timeline-item__wrapper\"><div class=\"wp-block-getwid-content-timeline-item__card\"><div class=\"wp-block-getwid-content-timeline-item__card-wrapper\"><div class=\"wp-block-getwid-content-timeline-item__content-wrapper\"><div class=\"wp-block-getwid-content-timeline-item__mobile-meta\"><p class=\"wp-block-getwid-content-timeline-item__meta-content\"><strong>December 29th, 2023<\/strong><\/p><\/div>\n<ul class=\"wp-block-list\">\n<li>\uc2dc\uc124 \ub4f1\ub85d \ubc0f \uc81c\ud488 \ub4f1\ub85d \uc694\uac74<\/li>\n\n\n\n<li><span style=\"background-color: inherit; color: var(--grimlock-text-color); font-weight: var(--grimlock-text-font-weight);\">\uc804\ubb38\uac00\uc6a9 \uc81c\ud488\uc5d0 \ud544\uc694\ud55c \ud544\uc218 \uc694\uc18c \ub77c\ubca8\ub9c1.<\/span><\/li>\n\n\n\n<li><span style=\"background-color: inherit; color: var(--grimlock-text-color); font-weight: var(--grimlock-text-font-weight);\">\ubd80\uc791\uc6a9\uc744 \ucd94\uc801, \uae30\ub85d \ubc0f \ubcf4\uace0\ud560 \uc758\ubb34: \ubaa8\ub4e0 \uc81c\ud488\uc758 \uc548\uc804\uc131\uc740 \uc801\uc808\ud788 \uc785\uc99d\ub418\uc5b4\uc57c \ud569\ub2c8\ub2e4.<\/span><\/li>\n\n\n\n<li>FDA\uc5d0\uc11c \uc81c\uc548\ud55c \ud0c8\ud06c \ud14c\uc2a4\ud2b8 \ud45c\uc900\ud654 \ubc29\ubc95.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n<\/div><\/div><\/div><div class=\"wp-block-getwid-content-timeline-item__point\"><div class=\"wp-block-getwid-content-timeline-item__point-content\"><\/div><\/div><div class=\"wp-block-getwid-content-timeline-item__meta\"><p class=\"wp-block-getwid-content-timeline-item__meta-content\"><strong>December 29th, 2023<\/strong><\/p><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-getwid-content-timeline-item\"><div class=\"wp-block-getwid-content-timeline-item__wrapper\"><div class=\"wp-block-getwid-content-timeline-item__card\"><div class=\"wp-block-getwid-content-timeline-item__card-wrapper\"><div class=\"wp-block-getwid-content-timeline-item__content-wrapper\"><div class=\"wp-block-getwid-content-timeline-item__mobile-meta\"><p class=\"wp-block-getwid-content-timeline-item__meta-content\"><strong>June 2024<\/strong><\/p><\/div>\n<ul class=\"wp-block-list\">\n<li>FDA\uc5d0\uc11c \uc81c\uc548\ud55c \uc54c\ub808\ub974\uac90 \ub77c\ubca8\ub9c1 \uaddc\uce59 \uc81c\uc815<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n<\/div><\/div><\/div><div class=\"wp-block-getwid-content-timeline-item__point\"><div class=\"wp-block-getwid-content-timeline-item__point-content\"><\/div><\/div><div class=\"wp-block-getwid-content-timeline-item__meta\"><p class=\"wp-block-getwid-content-timeline-item__meta-content\"><strong>June 2024<\/strong><\/p><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-getwid-content-timeline-item\"><div class=\"wp-block-getwid-content-timeline-item__wrapper\"><div class=\"wp-block-getwid-content-timeline-item__card\"><div class=\"wp-block-getwid-content-timeline-item__card-wrapper\"><div class=\"wp-block-getwid-content-timeline-item__content-wrapper\"><div class=\"wp-block-getwid-content-timeline-item__mobile-meta\"><p class=\"wp-block-getwid-content-timeline-item__meta-content\"><strong> August 2024*<\/strong><\/p><\/div>\n<ul class=\"wp-block-list\">\n<li>\ud0c8\ud06c \ud14c\uc2a4\ud2b8 \ud45c\uc900\ud654 \ubc29\ubc95 \ud655\uc815<\/li>\n<\/ul>\n<\/div><\/div><\/div><div class=\"wp-block-getwid-content-timeline-item__point\"><div class=\"wp-block-getwid-content-timeline-item__point-content\"><\/div><\/div><div class=\"wp-block-getwid-content-timeline-item__meta\"><p class=\"wp-block-getwid-content-timeline-item__meta-content\"><strong> August 2024*<\/strong><\/p><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-getwid-content-timeline-item\"><div class=\"wp-block-getwid-content-timeline-item__wrapper\"><div class=\"wp-block-getwid-content-timeline-item__card\"><div class=\"wp-block-getwid-content-timeline-item__card-wrapper\"><div class=\"wp-block-getwid-content-timeline-item__content-wrapper\"><div class=\"wp-block-getwid-content-timeline-item__mobile-meta\"><p class=\"wp-block-getwid-content-timeline-item__meta-content\"><strong>December 29th 2024<\/strong><\/p><\/div>\n<ul class=\"wp-block-list\">\n<li>GMP \uaddc\uce59 \uc81c\uc815 \uc81c\uc548<\/li>\n\n\n\n<li>\ubaa8\ub4e0 \uc81c\ud488\uc5d0 \ud544\uc694\ud55c \ud544\uc218 \uc694\uc18c \ub77c\ubca8\ub9c1<\/li>\n<\/ul>\n<\/div><\/div><\/div><div class=\"wp-block-getwid-content-timeline-item__point\"><div class=\"wp-block-getwid-content-timeline-item__point-content\"><\/div><\/div><div class=\"wp-block-getwid-content-timeline-item__meta\"><p class=\"wp-block-getwid-content-timeline-item__meta-content\"><strong>December 29th 2024<\/strong><\/p><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-getwid-content-timeline-item\"><div class=\"wp-block-getwid-content-timeline-item__wrapper\"><div class=\"wp-block-getwid-content-timeline-item__card\"><div class=\"wp-block-getwid-content-timeline-item__card-wrapper\"><div class=\"wp-block-getwid-content-timeline-item__content-wrapper\"><div class=\"wp-block-getwid-content-timeline-item__mobile-meta\"><p class=\"wp-block-getwid-content-timeline-item__meta-content\"><strong>February 2025*<\/strong><\/p><\/div>\n<ul class=\"wp-block-list\">\n<li>\uc54c\ub808\ub974\uae30 \uc720\ubc1c \ubb3c\uc9c8 \ub77c\ubca8\ub9c1 \uaddc\uc815 \ud655\uc815<\/li>\n<\/ul>\n<\/div><\/div><\/div><div class=\"wp-block-getwid-content-timeline-item__point\"><div class=\"wp-block-getwid-content-timeline-item__point-content\"><\/div><\/div><div class=\"wp-block-getwid-content-timeline-item__meta\"><p class=\"wp-block-getwid-content-timeline-item__meta-content\"><strong>February 2025*<\/strong><\/p><\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-getwid-content-timeline-item\"><div class=\"wp-block-getwid-content-timeline-item__wrapper\"><div class=\"wp-block-getwid-content-timeline-item__card\"><div class=\"wp-block-getwid-content-timeline-item__card-wrapper\"><div class=\"wp-block-getwid-content-timeline-item__content-wrapper\"><div class=\"wp-block-getwid-content-timeline-item__mobile-meta\"><p class=\"wp-block-getwid-content-timeline-item__meta-content\"><strong>29 December 2025<\/strong><\/p><\/div>\n<ul class=\"wp-block-list\">\n<li>FDA \uc6f9\uc0ac\uc774\ud2b8\uc5d0 PFAS \ubcf4\uace0\uc11c \uac8c\uc2dc<\/li>\n\n\n\n<li>GMP \uaddc\uc815 \ud655\uc815<\/li>\n<\/ul>\n<\/div><\/div><\/div><div class=\"wp-block-getwid-content-timeline-item__point\"><div class=\"wp-block-getwid-content-timeline-item__point-content\"><\/div><\/div><div class=\"wp-block-getwid-content-timeline-item__meta\"><p class=\"wp-block-getwid-content-timeline-item__meta-content\"><strong>29 December 2025<\/strong><\/p><\/div><\/div><\/div>\n<\/div><\/div>\n\n<p class=\"wp-block-paragraph\"><a id=\"_msocom_1\"><\/a><\/p>\n\n<p class=\"wp-block-paragraph\">*<em>60\uc77c\uac04\uc758 \uc758\uacac \uc218\ub834 \uae30\uac04\uacfc \uacf5\uac1c \uc758\uacac \uc218\ub834 \uae30\uac04 \uc885\ub8cc \ud6c4 180\uc77c \uc774\ub0b4\uc5d0 \ucd5c\uc885 \ud655\uc815\ud558\ub3c4\ub85d \ud55c \uc9c0\uce68\uc744 \uae30\uc900\uc73c\ub85c<\/em> \ucd94\uc0b0\ud55c \uc218\uce58\uc785\ub2c8\ub2e4.<\/p>\n\n<h2 class=\"wp-block-heading\">\ubb38\uc758\ud558\uae30<\/h2>\n\n<p class=\"wp-block-paragraph\">\uc870\uc5b8, \uacac\uc801 \ub610\ub294 \uc9c8\ubb38\uc5d0 \ub300\ud55c \ub2f5\ubcc0\uc774 \ud544\uc694\ud558\uc2e0\uac00\uc694? \ubb38\uc758\ud558\uae30&#8230;<\/p>\n\n<p class=\"wp-block-paragraph\">\uc774 \uc591\uc2dd\uc744 \uc791\uc131\ud558\uac70\ub098 \uc9c1\uc811 \ubb38\uc758\ud558\uc138\uc694: <a href=\"mailto:%20info@biorius.com\">info@biorius.com<\/a> &#8211; \ucd5c\ub300\ud55c \ube68\ub9ac \ub2f5\ubcc0\ud574 \ub4dc\ub9ac\uaca0\uc2b5\ub2c8\ub2e4!<\/p>\n","protected":false},"excerpt":{"rendered":"<p>2022\ub144 \ud654\uc7a5\ud488 \uaddc\uc81c \ud604\ub300\ud654\ubc95(MoCRA) 2022\ub144 12\uc6d4 29\uc77c, \uac00\uc7a5 \uc911\uc694\ud55c \uac83\uc740 \ud654\uc7a5\ud488 \uc694\uac74 (21 U.S.C., Sec. 321-392)\uac00 1938\ub144 \uc81c\uc815\ub41c \uc774\ub798 \uac00\uc7a5 \uc911\uc694\ud55c \uac1c\uc815\uc548\uc774 \uc2dc\ud589\ub429\ub2c8\ub2e4. \uc774 \uc0c8\ub85c\uc6b4&#8230;<\/p>\n","protected":false},"author":2,"featured_media":42926,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_coblocks_attr":"","_coblocks_dimensions":"","_coblocks_responsive_height":"","_coblocks_accordion_ie_support":"","footnotes":""},"categories":[2404,2407],"tags":[2405,2406,2370,2350,2352],"ppma_author":[2594],"class_list":["post-49569","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-mocra-ko","category-2407","tag-mocra-ko","tag-usa-ko","tag-2370","tag-2350","tag-2352","author-nicolas-lenaersbiorius-com"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>MoCRA - Biorius<\/title>\n<meta name=\"description\" content=\"\uc81c\uc870 \uc2dc\uc124\uc744 \uc815\uc9c0\ud558\uac70\ub098 \uc81c\ud488 \ub9ac\ucf5c\uc744 \uba85\ub839\ud560 \uc218 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