{"id":49563,"date":"2023-06-08T00:00:00","date_gmt":"2023-06-07T22:00:00","guid":{"rendered":"https:\/\/biorius.com\/cosmetic-news\/%e3%83%a2cra\/"},"modified":"2024-05-08T11:43:45","modified_gmt":"2024-05-08T09:43:45","slug":"%e3%83%a2cra","status":"publish","type":"post","link":"https:\/\/biorius.com\/ja\/cosmetic-news\/%e3%83%a2cra\/","title":{"rendered":"\u30e2CRA"},"content":{"rendered":"\n<div style=\"height:66px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h1 class=\"wp-block-heading\"><strong>2022\u5e74\u5316\u7ca7\u54c1\u898f\u5236\u8fd1\u4ee3\u5316\u6cd5\uff08MoCRA\uff09<\/strong><\/h1>\n\n<div style=\"height:38px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p>2022\u5e7412\u6708<sup>29<\/sup>\u65e5\u3001\u6700\u3082\u91cd\u8981\u306a\u3053\u3068\u304c\u767a\u8868\u3055\u308c\u305f\u3002 <strong>\n  <a href=\"https:\/\/mcusercontent.com\/d3d80b99002742cef41679506\/files\/6801d875-47e1-ee8d-693d-9164b7eb182a\/MOCRA.pdf\">\u5316\u7ca7\u54c1\u8981\u4ef6<\/a>\n<\/strong>(21 U.S.C., Sec. 321-392\uff09\u304c\u5236\u5b9a\u3055\u308c\u305f\u3002 \u3053\u306e\u65b0\u3057\u3044\u6cd5\u5f8b\u306f\u3001\u5316\u7ca7\u54c1\u696d\u754c\u306b\u65b0\u305f\u306a\u7fa9\u52d9\u3092\u5c0e\u5165\u3059\u308b\u3082\u306e\u3067\u3001\u7c73\u56fd\u3067\u8ca9\u58f2\u3059\u308b\u5316\u7ca7\u54c1\u30d6\u30e9\u30f3\u30c9\u306b\u3068\u3063\u3066\u5927\u304d\u306a\u5f71\u97ff\u304c\u4e88\u60f3\u3055\u308c\u307e\u3059\u3002 MoCRA\u306f\u65b0\u305f\u306a\u898f\u5236\u6761\u9805\u3092\u8a2d\u3051\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u3053\u306e\u5730\u57df\u306b\u304a\u3051\u308b\u5316\u7ca7\u54c1\u898f\u5236\u306e\u3042\u308a\u65b9\u306b\u304a\u3051\u308b\u30d1\u30e9\u30c0\u30a4\u30e0\u30b7\u30d5\u30c8\u3068\u8003\u3048\u3089\u308c\u3066\u3044\u308b\u3002 \u516c\u8846\u885b\u751f\u3092\u5b88\u308b\u305f\u3081\u3001FDA\u306b\u76e3\u8996\u3001\u691c\u67fb\u3001\u5dee\u3057\u6b62\u3081\u306e\u6a29\u9650\u304c\u3088\u308a\u591a\u304f\u5272\u308a\u5f53\u3066\u3089\u308c\u308b\u3002 \u305d\u306e\u4ed6\u306e\u7fa9\u52d9\u3068\u3057\u3066\u3001FDA\u306fMoCRA\u306e\u3082\u3068\u3001\u65bd\u8a2d\u306e\u767b\u9332\u3092\u4e00\u6642\u505c\u6b62\u3057\u3001\u88fd\u54c1\u56de\u53ce\u3092\u547d\u3058\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002 \u305d\u306e\u610f\u5473\u3067\u3001\u7c73\u56fd\u306b\u304a\u3051\u308b\u5316\u7ca7\u54c1\u898f\u5236\u306e\u3042\u308a\u65b9\u306f\u3001\u6b27\u5dde\u6cd5\u306e\u7406\u5ff5\u3068\u4e00\u81f4\u3059\u308b\u50be\u5411\u304c\u3042\u308b\u3002<\/p>\n\n<p><\/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\" style=\"font-size:22px\"><strong>\u30d3\u30aa\u30ea\u30a2\u30b9\u306f\u73fe\u5728\u3001\u3053\u306e\u65b0\u3057\u3044\u6cd5\u5f8b\u306b\u95a2\u3059\u308b\u3042\u3089\u3086\u308b\u30cb\u30fc\u30ba\u306b\u5bfe\u5fdc\u3067\u304d\u308b\u3088\u3046\u5b8c\u5168\u306b\u7d44\u7e54\u5316\u3055\u308c\u3001\u305d\u306e\u4ee3\u7406\u5e97\u3067\u3042\u308b\u30d3\u30aa\u30ea\u30a2\u30b9\u793e\u3092\u901a\u3058\u3066\u3001\u51e6\u65b9\u5206\u6790\u304b\u3089\u7c73\u56fd\u306b\u304a\u3051\u308b\u5316\u7ca7\u54c1\u306e\u6cd5\u7684\u4ee3\u7406\u6a29\u306b\u81f3\u308b\u307e\u3067\u3001\u300cMoCRA\u30bf\u30fc\u30f3\u30ad\u30fc\u30fb\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u300d\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002<\/strong><\/p>\n\n\n\n<p class=\"has-content-background-color-color has-text-color\" style=\"font-size:22px\"><strong>\u79c1\u305f\u3061\u306f\u3001EU\u3068\u82f1\u56fd\u306715\u5e74\u9593\u5b9f\u8a3c\u3057\u3066\u304d\u305f\u306e\u3068\u540c\u3058\u52b9\u80fd\u3067\u3001\u7c73\u56fd\u3067\u306e\u6d3b\u52d5\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002 \u3053\u306e\u65b0\u3057\u3044\u6cd5\u5f8b\u306b\u3064\u3044\u3066\u3054\u8cea\u554f\u304c\u3042\u308a\u307e\u3057\u305f\u3089\u3001\u9060\u616e\u306a\u304f\u3054\u9023\u7d61\u304f\u3060\u3055\u3044\u3002<\/strong><\/p>\n\n\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-16018d1d 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\/ja\/contact\/\">\u304a\u554f\u3044\u5408\u308f\u305b<\/a><\/div>\n<\/div>\n\n\n\n<p><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\">\u8cac\u4efb\u8005<strong>\uff0f<a href=\"https:\/\/biorius.com\/cosmetics-compliance\/usa-cosmetics-regulation\/mocra\/us-agent-responsible-person\/\">\u7c73\u56fd\u4ee3\u7406\u4eba<\/a><\/strong><\/h2>\n\n<p>\u3059\u3079\u3066\u306e\u5316\u7ca7\u54c1\u306b\u306f\u3001\u7b2c604\u6761(4)\u3067\u5b9a\u7fa9\u3055\u308c\u308b\u8cac\u4efb\u8005\u3092\u6307\u5b9a\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u8cac\u4efb\u8005\u306f\u88fd\u9020\u8005\u3001\u5305\u88c5\u696d\u8005\u3001\u8ca9\u58f2\u696d\u8005\u306e\u3044\u305a\u308c\u3067\u3082\u3088\u3044\u3002 \u8cac\u4efb\u8005\u306e\u6c0f\u540d\u304a\u3088\u3073\u4f4f\u6240\u3092\u88fd\u54c1\u30e9\u30d9\u30eb\u306b\u660e\u8a18\u3059\u308b\u3053\u3068\u3002<\/p>\n\n<p><\/p>\n\n<p>FDA\u304c2023\u5e746\u6708\u306b\u660e\u3089\u304b\u306b\u3057\u305f\u3088\u3046\u306b\u3001\u8cac\u4efb\u8005\u306f\u7c73\u56fd\u5185\u306b\u3044\u308b\u5fc5\u8981\u306f\u306a\u3044\u3002 \u305f\u3060\u3057\u3001\u5916\u56fd\u306e\u8cac\u4efb\u8005\u306f\u3001\u7c73\u56fd\u306b\u6240\u5728\u3059\u308b\u4ee3\u7406\u4eba\u3092\u6307\u5b9a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 \u8cac\u4efb\u8005\u304a\u3088\u3073\u7c73\u56fd\u4ee3\u7406\u4eba\u306e\u5f79\u5272\u306b\u95a2\u9023\u3059\u308b\u7fa9\u52d9\u306e\u8a73\u7d30\u306b\u3064\u3044\u3066\u306f\u3001<a href=\"https:\/\/biorius.com\/cosmetics-compliance\/usa-cosmetics-regulation\/mocra\/us-agent-responsible-person\/\">\u3053\u306e\u30c8\u30d4\u30c3\u30af\u306e\u30da\u30fc\u30b8\u3092<\/a>\u3054\u89a7\u304f\u3060\u3055\u3044\u3002<\/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\" data-coblocks-animation=\"fadeIn\"><strong>\u9577\u5e74\u306b\u308f\u305f\u308aEU\u304a\u3088\u3073\u82f1\u56fd\u306e\u8cac\u4efb\u8005\u3092\u52d9\u3081\u3066\u304d\u305f\u30d0\u30a4\u30aa\u30ea\u30a6\u30b9\u306f\u3001MoCRA\u306e\u5c0e\u5165\u306b\u4f34\u3044\u3001\u7c73\u56fd\u4ee3\u7406\u5e97\u3068\u3057\u3066\u306e\u30b5\u30dd\u30fc\u30c8\u3092\u62e1\u5927\u3059\u308b\u6e96\u5099\u304c\u6574\u3044\u307e\u3057\u305f\u3002<\/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\/ja\/contact\/\">\u304a\u554f\u3044\u5408\u308f\u305b<\/a><\/div>\n<\/div>\n<\/div><\/div>\n<\/div><\/div>\n\n<p><\/p>\n\n<h2 class=\"wp-block-heading\"><strong>\u65bd\u8a2d\u767b\u9332\u3068\u5316\u7ca7\u54c1\u767b\u9332<\/strong><\/h2>\n\n<p>\u7b2c607\u6761\u3067\u898f\u5b9a\u3055\u308c\u3066\u3044\u308b\u3088\u3046\u306b\u3001MoCRA\u306b\u306f\u65bd\u8a2d\u767b\u9332\u3068\u5316\u7ca7\u54c1\u767b\u9332\u3068\u3044\u3046\u767b\u9332\u7fa9\u52d9\u3082\u3042\u308b\u3002 \u3053\u306e2\u3064\u306e\u30aa\u30da\u30ec\u30fc\u30b7\u30e7\u30f3\u306f\u540c\u3058\u30b7\u30b9\u30c6\u30e0\u3092\u901a\u3058\u3066\u884c\u308f\u308c\u3001\u540c\u6642\u306b\u884c\u308f\u308c\u308b\u3053\u3068\u3082\u3042\u308b\uff1a<\/p>\n\n<p><\/p>\n\n<h3 class=\"wp-block-heading\">\u65bd\u8a2d\u767b\u9332<\/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>\u7c73\u56fd\u3067\u5316\u7ca7\u54c1\u306e\u88fd\u9020\u3001\u52a0\u5de5\u3001\u6d41\u901a\u306b\u643a\u308f\u308b\u65bd\u8a2d\u306f\u3001FDA\u306e\u5c02\u7528IT\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u306b\u767b\u9332\u3057\u3001\u3053\u306e\u767b\u9332\u3092\u6700\u65b0\u306e\u72b6\u614b\u306b\u7dad\u6301\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\uff08Sec. 607 (a)). \u65e2\u5b58\u65bd\u8a2d\u306e\u767b\u9332\u671f\u9650\u306f2023\u5e7412\u6708<sup>29<\/sup>\u65e5\u307e\u3067<\/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>\u3053\u308c\u3089\u306e\u65bd\u8a2d\u767b\u9332\u306f2\u5e74\u3054\u3068\u306b\u66f4\u65b0\u3055\u308c\u3001\u65b0\u3057\u3044\u65bd\u8a2d\u306f\u3001\u305d\u306e\u6d3b\u52d5\u306b\u521d\u3081\u3066\u5f93\u4e8b\u3057\u305f\u5f8c60\u65e5\u4ee5\u5185\uff08\u307e\u305f\u306f2023\u5e7412\u6708<sup>29<\/sup>\u65e5\u306b\u7d42\u4e86\u3059\u308b\u6700\u521d\u306e\u79fb\u884c\u671f\u9593\u306e\u5f8c60\u65e5\u4ee5\u5185\uff09\u306b\u767b\u9332\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/p>\n<\/div><\/div>\n<\/div><\/div>\n\n<p><\/p>\n\n<h3 class=\"wp-block-heading\">\u5316\u7ca7\u54c1\u30ea\u30b9\u30c8<\/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-9d6595d7 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-9d6595d7 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>\u8cac\u4efb\u8005\u306f\u3001FDA\u306b\u8ca9\u58f2\u3059\u308b\u5316\u7ca7\u54c1\u306e\u6700\u65b0\u30ea\u30b9\u30c8\u3092\u6bce\u5e74\u63d0\u51fa\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002 \u30ea\u30b9\u30c8\u306b\u306f\u3001\u5546\u54c1\u540d\u3001\u7a2e\u985e\u3001\u6210\u5206\u306a\u3069\u306e\u8a73\u7d30\u3092\u8a18\u8f09\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002 \u5316\u7ca7\u54c1\u30ea\u30b9\u30c8\u306f2023\u5e7412\u6708<sup>29<\/sup>\u65e5\u307e\u3067\u306b\u63d0\u51fa\u3055\u308c\u3001\u65b0\u3057\u3044\u5316\u7ca7\u54c1\u306f\u5dde\u3092\u307e\u305f\u304c\u308b\u5546\u53d6\u5f15\u3067\u8ca9\u58f2\u3055\u308c\u3066\u304b\u3089120\u65e5\u4ee5\u5185\u306b\u30ea\u30b9\u30c8\u30a2\u30c3\u30d7\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/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>\u65bd\u8a2d\u767b\u9332\u3068\u540c\u69d8\u3001\u5316\u7ca7\u54c1\u306e\u30ea\u30b9\u30c8\u30a2\u30c3\u30d7\u3082FDA\u304c\u63d0\u4f9b\u3059\u308bIT\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\uff08\u672a\u5b9a\uff09\u306b\u3088\u3063\u3066\u53ef\u80fd\u3068\u306a\u308b\u3002 \u3053\u306e\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u306f\u30012023\u5e743\u6708<sup>27<\/sup>\u65e5\u306b\u5ec3\u6b62\u3055\u308c\u305f\u5316\u7ca7\u54c1\u81ea\u4e3b\u767b\u9332\u5236\u5ea6\uff08VCRP\uff09\u5c02\u7528\u306e\u65e7\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3092\u30d9\u30fc\u30b9\u306b\u958b\u767a\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002 \u3057\u304b\u3057\u3001\u3053\u306eVCRP\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306f\u65b0\u30b7\u30b9\u30c6\u30e0\u306b\u306f\u79fb\u884c\u3055\u308c\u305a\u3001FDA\u306b\u3088\u3063\u3066\u30a2\u30fc\u30ab\u30a4\u30d6\u3055\u308c\u308b\u3053\u3068\u304c\u308f\u304b\u3063\u3066\u3044\u308b\u3002<\/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>\u5316\u7ca7\u54c1\u306b\u95a2\u3059\u308b1\u3064\u306e\u30ea\u30b9\u30c6\u30a3\u30f3\u30b0\u7533\u8acb\u306b\u306f\u3001\u540c\u4e00\u306e\u51e6\u65b9\u3092\u6709\u3059\u308b\u8907\u6570\u306e\u5316\u7ca7\u54c1\u3001\u307e\u305f\u306f\u8272\u3001\u9999\u6599\u3082\u3057\u304f\u306f\u30d5\u30ec\u30fc\u30d0\u30fc\u3001\u307e\u305f\u306f\u542b\u6709\u91cf\u306b\u95a2\u3057\u3066\u306e\u307f\u7570\u306a\u308b\u51e6\u65b9\u3092\u6709\u3059\u308b\u8907\u6570\u306e\u5316\u7ca7\u54c1\u3092\u542b\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002<\/p>\n<\/div>\n<\/div>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u5b89\u5168\u6027\u306e\u7acb\u8a3c<\/strong><\/h2>\n\n\n\n<p><\/p>\n\n\n\n<p>MoCRA\u306fSec.608\u306b\u304a\u3044\u3066\u3001\u5316\u7ca7\u54c1\u306e\u8cac\u4efb\u8005\u306f\u3001\u88fd\u54c1\u306e\u5b89\u5168\u6027\u3092\u9069\u5207\u306b\u7acb\u8a3c\u3059\u308b\u305f\u3081\u306e\u8a18\u9332\u3092\u78ba\u5b9f\u306b\u4fdd\u7ba1\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3068\u898f\u5b9a\u3057\u3066\u3044\u308b\u3002<\/p>\n\n\n\n<p>\u672c\u6539\u6b63\u6848\u306f\u3001\u5316\u7ca7\u54c1\u306e\u5b89\u5168\u6027\u3092\u9069\u5207\u306b\u7acb\u8a3c\u3059\u308b\u65b9\u6cd5\u306b\u3064\u3044\u3066\u898f\u5b9a\u3059\u308b\u3082\u306e\u3067\u306f\u306a\u3044\u304c\u3001\u4ee5\u4e0b\u306e\u70b9\u3092\u660e\u78ba\u306b\u3057\u3066\u3044\u308b\u3002<em>\u5316\u7ca7\u54c1\u3068\u305d\u306e\u6210\u5206\u306e\u5b89\u5168\u6027\u3092\u8a55\u4fa1\u3059\u308b\u79d1\u5b66\u7684\u8a13\u7df4\u3068\u7d4c\u9a13\u3092\u7a4d\u3093\u3060\u5c02\u9580\u5bb6\u306e\u9593\u3067\u3001\u5316\u7ca7\u54c1\u304c\u5b89\u5168\u3067\u3042\u308b\u3068\u3044\u3046\u5408\u7406\u7684\u306a\u78ba\u4fe1\u3092\u88cf\u4ed8\u3051\u308b\u306e\u306b\u5341\u5206\u3067\u3042\u308b\u3068\u8003\u3048\u3089\u308c\u308b\u8a66\u9a13\u3084\u7814\u7a76\u3001\u8abf\u67fb\u3001\u5206\u6790\u3001\u305d\u306e\u4ed6\u306e\u8a3c\u62e0\u3084\u60c5\u5831\u3002<\/em>&#8220;.<\/p>\n\n\n\n<p class=\"is-style-info\">\u3053\u308c\u306b\u57fa\u3065\u304d\u3001\u3055\u3089\u306b\u95a2\u9023\u696d\u754c\u56e3\u4f53\u3068\u5354\u8b70\u3092\u91cd\u306d\u305f\u7d50\u679c\u3001\u30d3\u30aa\u30ea\u30a2\u30b9\u306f\u3001\u6b27\u5dde\u5316\u7ca7\u54c1\u898f\u5236EC No 1223\/2009\u306b\u5f93\u3063\u3066\u4f5c\u6210\u3055\u308c\u305f\u5316\u7ca7\u54c1\u5b89\u5168\u6027\u5831\u544a\u66f8\uff08CPSR\uff09\u304c\u3001\u7c73\u56fd\u306b\u304a\u3051\u308b\u5316\u7ca7\u54c1\u306e\u5b89\u5168\u6027\u3092\u5341\u5206\u306b\u7acb\u8a3c\u3059\u308b\u306e\u306b\u5341\u5206\u3067\u3042\u308b\u3068\u5224\u65ad\u3055\u308c\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u305f\u3002 EU\u3084\u82f1\u56fd\u3067\u8ca9\u58f2\u3055\u308c\u3066\u3044\u306a\u3044\u5316\u7ca7\u54c1\u306f\u3001CPSR\u3068\u540c\u3058\u76ee\u7684\u3067\u6bd2\u6027\u5b66\u7684\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u304c\u5fc5\u8981\u3068\u306a\u308b\u3002<\/p>\n\n\n\n<p>\u6700\u5f8c\u306b\u3001\u7b2c614\u6761(a)\u306f\u3001\u3044\u304b\u306a\u308b\u5dde\u3082\u3001MoCRA\u306e\u4e0b\u3067\u9069\u7528\u3055\u308c\u308b\u8981\u4ef6\u3068\u300c\u7570\u306a\u308b\u304b\u3001\u8ffd\u52a0\u3055\u308c\u308b\u304b\u3001\u3055\u3082\u306a\u3051\u308c\u3070\u540c\u4e00\u3067\u306f\u306a\u3044\u300d\u5316\u7ca7\u54c1\u306e\u5b89\u5168\u6027\u7acb\u8a3c\u306b\u95a2\u3059\u308b\u6cd5\u5f8b\u3084\u898f\u5236\u3092\u5236\u5b9a\u3057\u305f\u308a\u3001\u305d\u306e\u52b9\u529b\u3092\u7d99\u7d9a\u3057\u305f\u308a\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u306a\u3044\u3068\u5b9a\u3081\u3066\u3044\u308b\u3002<\/p>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u30e9\u30d9\u30eb\u306e\u5fc5\u9808\u8981\u7d20<\/strong><\/h2>\n\n\n\n<p>MoCRA\u306e\u7b2c609\u6761\u306f\u3001\u65b0\u305f\u306a\u8868\u793a\u7fa9\u52d9\u3092\u5b9a\u3081\u3066\u3044\u308b\u3002 \u305d\u306e\u65bd\u884c\u306f\u300121 U.S.C., Sec. 321-392 (FD&amp;C Act, implemented via 21 C.F.R., Sec. 700-740)\u308415 U.S.C., Sec. 1451-1460 (Fair Packaging and Labeling Act, implemented via 16 C.F.R., Sec. 500-503)\u3067\u4e88\u898b\u3055\u308c\u308b\u3088\u3046\u306a\u901a\u5e38\u306e\u8868\u793a\u8981\u4ef6\u306b\u4f55\u3089\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u3082\u306e\u3067\u306f\u306a\u3044\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u3053\u308c\u3089\u306e\u65b0\u3057\u3044\u8868\u793a\u8981\u4ef6\u306b\u306f\u3001\u8cac\u4efb\u8005\uff08\u307e\u305f\u306f\u305d\u306e\u7c73\u56fd\u4ee3\u7406\u4eba\uff09\u304c\u6709\u5bb3\u4e8b\u8c61\u5831\u544a\u3092\u53d7\u3051\u53d6\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u56fd\u5185\u306e\u4f4f\u6240\u3001\u96fb\u8a71\u756a\u53f7\u3001\u307e\u305f\u306f\u96fb\u5b50\u9023\u7d61\u5148\u60c5\u5831\u304c\u542b\u307e\u308c\u308b\u3002 \u3053\u306e\u8868\u793a\u7fa9\u52d9\u306b\u5bfe\u5fdc\u3059\u308b\u305f\u3081\u306e\u79fb\u884c\u671f\u9593\u306f2\u5e74\u9593\u3067\u30012024\u5e7412\u670829\u65e5\u307e\u3067\u306b\u7c73\u56fd\u5e02\u5834\u306b\u6295\u5165\u3055\u308c\u308b\u5316\u7ca7\u54c1\u306e\u5305\u88c5\u306b\u5bfe\u5fdc\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/li>\n\n\n\n<li>FDA\u304c\u7279\u5b9a\u3059\u308b\u9999\u6599\u30a2\u30ec\u30eb\u30b2\u30f3\u306e\u958b\u793a\u3002 FDA\u306f\u30012024\u5e745\u6708<sup>29<\/sup>\u65e5\u307e\u3067\u306b\u958b\u793a\u3059\u3079\u304d\u3053\u308c\u3089\u306e\u9999\u6599\u30a2\u30ec\u30eb\u30b2\u30f3\u3092\u7279\u5b9a\u3057\u3001\u898f\u5247\u4f5c\u6210\u6848\u306b\u5bfe\u3059\u308b\u30d1\u30d6\u30ea\u30c3\u30af\u30b3\u30e1\u30f3\u30c8\u671f\u9593\u304c\u7d42\u4e86\u3057\u305f\u65e5\u304b\u3089180\u65e5\u5f8c\u307e\u3067\u306b\u6700\u7d42\u898f\u5247\u3092\u4f5c\u6210\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/li>\n\n\n\n<li>\u5c02\u9580\u5bb6\u306e\u307f\u304c\u4f7f\u7528\u3059\u308b\u3053\u3068\u3092\u610f\u56f3\u3057\u305f\u88fd\u54c1\u306b\u3064\u3044\u3066\u306f\u3001\u8a8d\u53ef\u3092\u53d7\u3051\u305f\u5c02\u9580\u5bb6\u306b\u3088\u3063\u3066\u6295\u4e0e\u307e\u305f\u306f\u4f7f\u7528\u3055\u308c\u308b\u3079\u304d\u3053\u3068\u3092\u793a\u3057\u3001\u3053\u306e\u70b9\u306b\u95a2\u3057\u3066\u5b9a\u3081\u3089\u308c\u305fFDA\u306e\u8981\u4ef6\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3001\u660e\u78ba\u3067\u76ee\u7acb\u3064\u30e9\u30d9\u30eb\u8868\u793a\u3002 \u3053\u306e\u8868\u793a\u7fa9\u52d9\u306f2023\u5e7412\u6708<sup>29<\/sup>\u65e5\u304b\u3089\u9069\u7528\u3055\u308c\u308b\u3002<\/li>\n<\/ul>\n\n\n\n<p><\/p>\n\n\n\n<p>\u7b2c614\u6761(b)\u306b\u5831\u544a\u3055\u308c\u3066\u3044\u308b\u3088\u3046\u306b\u3001MoCRA\u306f\u3001\u5236\u5b9a\u6642\u306b\u6709\u52b9\u3067\u3042\u3063\u305f\u3001\u5316\u7ca7\u54c1\u306b\u542b\u307e\u308c\u308b\u6210\u5206\u306e\u5dde\u3078\u306e\u5831\u544a\u7fa9\u52d9\u3092\u3001\u3044\u304b\u306a\u308b\u5dde\u3082\u7d99\u7d9a\u3059\u308b\u3053\u3068\u3092\u59a8\u3052\u308b\u3082\u306e\u3067\u306f\u306a\u3044\u3002 \u8a00\u3044\u63db\u3048\u308c\u3070\u3001\u63d0\u6848\u306e\u3088\u3046\u306a\u30a4\u30cb\u30b7\u30a2\u30c1\u30d6\u306f\u3001\u300c\u6279\u51c6\u306e\u5fc5\u8981\u6027\u304c\u306a\u3044\u300d\u3068\u3044\u3046\u3053\u3068\u3067\u3042\u308b\u3002 \u30ab\u30ea\u30d5\u30a9\u30eb\u30cb\u30a2\u5dde\u306e65\u306f\u5f15\u304d\u7d9a\u304d\u5168\u9762\u7684\u306b\u9069\u7528\u3055\u308c\u308b\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u539f\u6750\u6599<\/strong><\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h3 class=\"wp-block-heading has-primary-color has-text-color\">\u30bf\u30eb\u30af\uff08\u7b2c3504\u6761\uff09<\/h3>\n\n\n\n<p>\u30bf\u30eb\u30af\u542b\u6709\u5316\u7ca7\u54c1\u4e2d\u306e\u30a2\u30b9\u30d9\u30b9\u30c8\u3092\u691c\u51fa\u30fb\u7279\u5b9a\u3059\u308b\u305f\u3081\u306e\u6a19\u6e96\u8a66\u9a13\u65b9\u6cd5\u306f\u3001MoCRA\u5236\u5b9a\u5f8c1\u5e74\u4ee5\u5185\uff082023\u5e7412\u6708<sup>29<\/sup>\u65e5\uff09\u306bFDA\u304c\u8d77\u8349\u3059\u308b\u3002 \u6a19\u6e96\u5316\u3055\u308c\u305f\u65b9\u6cd5\u3092\u5831\u544a\u3059\u308b\u6700\u7d42\u898f\u5247\u306f\u3001\u898f\u5247\u6848\u306b\u5bfe\u3059\u308b\u30d1\u30d6\u30ea\u30c3\u30af\u30b3\u30e1\u30f3\u30c8\u671f\u9593\u304c\u7d42\u4e86\u3057\u305f\u65e5\u304b\u3089\u9045\u304f\u3068\u3082180\u65e5\u4ee5\u5185\u306b\u63a1\u629e\u3055\u308c\u308b\u3002<\/p>\n\n\n\n<p><\/p>\n\n\n\n<h3 class=\"wp-block-heading has-primary-color has-text-color\">PFAS[Perfluoroalkyl and Polyfloroalkyl substances] (\u7b2c3506\u6761)<\/h3>\n\n\n\n<p>FDA\u306f\u3001\u5316\u7ca7\u54c1\u306b\u542b\u307e\u308c\u308b\u30da\u30eb\u30d5\u30eb\u30aa\u30ed\u30a2\u30eb\u30ad\u30eb\u304a\u3088\u3073\u30dd\u30ea\u30d5\u30eb\u30aa\u30ed\u30a2\u30eb\u30ad\u30eb\u7269\u8cea\u306e\u4f7f\u7528\u3068\u5b89\u5168\u6027\u3092\u3001\u95a2\u9023\u3059\u308b\u30ea\u30b9\u30af\u3082\u542b\u3081\u3066\u8a55\u4fa1\u3059\u308b\u3053\u3068\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u308b\u3002 \u8a55\u4fa1\u7d50\u679c\u3092\u307e\u3068\u3081\u305f\u5831\u544a\u66f8\u306f\u3001\u3053\u306e\u6cd5\u5f8b\u306e\u5236\u5b9a\u5f8c3\u5e74\u4ee5\u5185\u306bFDA\u306e\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u3067\u516c\u8868\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/p>\n\n\n\n<p><\/p>\n\n\n\n<h3 class=\"wp-block-heading has-primary-color has-text-color\">\u5236\u9650\u306a\u3057<\/h3>\n\n\n\n<p>\u7b2c614\u6761\uff08b\uff09\u306f\u3001MoCRA\u304c\u5316\u7ca7\u54c1\u306b\u542b\u307e\u308c\u308b\u6210\u5206\u306e\u91cf\u3092\u5236\u9650\u3059\u308b\u4f7f\u7528\u3092\u7981\u6b62\u3059\u308b\u3053\u3068\u3092\u3001\u3044\u304b\u306a\u308b\u5dde\u3082\u59a8\u3052\u308b\u3082\u306e\u3067\u306f\u306a\u3044\u3068\u5b9a\u3081\u3066\u3044\u308b\u3002 \u3057\u305f\u304c\u3063\u3066\u3001\u7c73\u56fd\u306e\u898f\u5b9a\u306f\u5f15\u304d\u7d9a\u304d\u5b8c\u5168\u306b\u9069\u7528\u3055\u308c\u308b\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u6709\u5bb3\u4e8b\u8c61  <\/h2>\n\n\n\n<div style=\"height:45px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 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\">\u7b2c605\u6761\u306f\u3001\u6709\u5bb3\u4e8b\u8c61\u306e\u5831\u544a\u304a\u3088\u3073\u7ba1\u7406\u306b\u95a2\u3059\u308b\u8cac\u4efb\u8005\u306e\u91cd\u8981\u306a\u7fa9\u52d9\u3092\u5b9a\u3081\u3066\u3044\u308b\u3002<\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 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\">\u91cd\u7be4\u306a\u6709\u5bb3\u4e8b\u8c61\uff08\u6b7b\u4ea1\u3001\u751f\u547d\u3092\u8105\u304b\u3059\u7d4c\u9a13\u3001\u5165\u9662\u3001\u6301\u7d9a\u7684\u307e\u305f\u306f\u91cd\u5927\u306a\u969c\u5bb3\u307e\u305f\u306f\u80fd\u529b\u969c\u5bb3\u3001\u5148\u5929\u7570\u5e38\u307e\u305f\u306f\u5148\u5929\u6027\u6b20\u640d\u3001\u611f\u67d3\u75c7\u3001\u5408\u7406\u7684\u306b\u4e88\u898b\u53ef\u80fd\u306a\u4f7f\u7528\u6761\u4ef6\u4e0b\u3067\u610f\u56f3\u3055\u308c\u305f\u4ee5\u5916\u306e\u91cd\u5927\u306a\u919c\u72b6\u3001\u307e\u305f\u306f\u305d\u306e\u3088\u3046\u306a\u7d50\u679c\u3092\u9632\u6b62\u3059\u308b\u305f\u3081\u306e\u533b\u7642\u4ecb\u5165\u3092\u5fc5\u8981\u3068\u3059\u308b\u6709\u5bb3\u4e8b\u8c61\u3068\u5b9a\u7fa9\u3055\u308c\u308b\uff09\u306f\u300115\u65e5\u4ee5\u5185\u306bFDA\u306b\u5831\u544a\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/p>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 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\">\u6709\u5bb3\u4e8b\u8c61\u306f\u8cac\u4efb\u8005\u306b\u3088\u3063\u3066\u8a18\u9332\u3055\u308c\u3001\u4e8b\u696d\u898f\u6a21\u306b\u5fdc\u3058\u3066\u6700\u4f4e3\u5e74\u3001\u6700\u95776\u5e74\u9593\u4fdd\u7ba1\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002 FDA\u306f\u3001\u4ed6\u306e\u65b0\u3057\u3044\u7fa9\u52d9\u306e\u4e2d\u3067\u3001\u3053\u308c\u3089\u306e\u8a18\u9332\u3092\u691c\u67fb\u3059\u308b\u6a29\u5229\u3092\u6709\u3059\u308b\u3002<\/p>\n<\/div>\n<\/div>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>\u9069\u6b63\u88fd\u9020\u57fa\u6e96<\/strong><\/h2>\n\n\n\n<p>MoCRA\u306f\u7b2c606\u6761\u3092\u901a\u3058\u3001<a href=\"https:\/\/biorius.com\/regulatory\/gmp-good-manufacturing-practices\/\">\u9069\u6b63\u88fd\u9020\u898f\u7bc4<\/a>\uff08GMP\uff09\u306e\u9075\u5b88\u7fa9\u52d9\u3082\u5c0e\u5165\u3057\u3066\u3044\u308b\u3002<\/p>\n\n\n\n<p>\u5316\u7ca7\u54c1\u306b\u4e0d\u7d14\u7269\u304c\u6df7\u5165\u3057\u3066\u3044\u306a\u3044\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3002 \u3053\u308c\u3089\u306e\u5177\u4f53\u7684\u306aGMP\u8981\u6c42\u4e8b\u9805\u306e\u8349\u6848\u306f\u3001MoCRA\u306e\u5236\u5b9a\u65e5\uff082022\u5e7412\u6708<sup>29<\/sup>\u65e5\uff09\u304b\u30892\u5e74\u4ee5\u5185\u306bFDA\u306b\u3088\u3063\u3066\u516c\u8868\u3055\u308c\u3001\u9045\u304f\u3068\u3082\u5236\u5b9a\u65e5\u304b\u30893\u5e74\u4ee5\u5185\u306b\u6700\u7d42\u5316\u3055\u308c\u308b\u3053\u3068\u3092\u76ee\u6307\u3059\u3002 \u73fe\u6bb5\u968e\u3067\u306f\u3001\u3053\u306e\u3088\u3046\u306aGMP\u306e\u8981\u4ef6\u306f\u3001\u53ef\u80fd\u306a\u9650\u308a\u56fd\u5185\u304a\u3088\u3073\u56fd\u969b\u7684\u306a\u57fa\u6e96\u306b\u5408\u308f\u305b\u308b\u5fc5\u8981\u304c\u3042\u308b\u3053\u3068\u3060\u3051\u304c\u308f\u304b\u3063\u3066\u3044\u308b\u3002<\/p>\n\n\n\n<p><\/p>\n\n\n\n<p>FDA\u306f\u3001\u5316\u7ca7\u54c1\u88fd\u9020\u306b\u5f93\u4e8b\u3059\u308b\u65bd\u8a2d\u306e\u8a18\u9332\u3092\u67fb\u5bdf\u3057\u3001\u3053\u308c\u3089\u306eGMP\u306e\u9075\u5b88\u3092\u78ba\u8a8d\u3059\u308b\u6a29\u9650\u3092\u6709\u3059\u308b\u3002 \u3057\u304b\u3057\u3001\u898f\u5236\u5f53\u5c40\u306fFDA\u306b\u5bfe\u3057\u3001\u4e2d\u5c0f\u4f01\u696d\u7279\u6709\u306e\u5236\u7d04\u306b\u8981\u4ef6\u3092\u9069\u5408\u3055\u305b\u308b\u3088\u3046\u6c42\u3081\u305f\u3002<\/p>\n<\/div>\n<\/div>\n\n<h2 class=\"wp-block-heading\"><strong>\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3<\/strong><\/h2>\n\n<p>\u3053\u308c\u3089\u306e\u5909\u66f4\u306f\u3059\u3079\u3066\u540c\u6642\u306b\u884c\u308f\u308c\u308b\u308f\u3051\u3067\u306f\u306a\u3044\u306e\u3067\u3001\u3053\u3053\u3067\u306f\u6b21\u306e\u30b9\u30c6\u30c3\u30d7\u3068\u9075\u5b88\u4e8b\u9805\u3092\u8981\u7d04\u3059\u308b\uff1a<\/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>\u65bd\u8a2d\u767b\u9332\u304a\u3088\u3073\u88fd\u54c1\u30ea\u30b9\u30c8\u8981\u4ef6\u3002<\/li>\n\n\n\n<li><span style=\"background-color: inherit; color: var(--grimlock-text-color); font-weight: var(--grimlock-text-font-weight);\">\u696d\u52d9\u7528\u88fd\u54c1\u306b\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u308b\u8981\u7d20\u8868\u793a\u3002<\/span><\/li>\n\n\n\n<li><span style=\"background-color: inherit; color: var(--grimlock-text-color); font-weight: var(--grimlock-text-font-weight);\">\u6709\u5bb3\u4e8b\u8c61\u306e\u8ffd\u8de1\u3001\u8a18\u9332\u3001\u5831\u544a\u7fa9\u52d9\uff1a\u3059\u3079\u3066\u306e\u88fd\u54c1\u306e\u5b89\u5168\u6027\u306f\u3001\u5341\u5206\u306b\u7acb\u8a3c\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002<\/span><\/li>\n\n\n\n<li>FDA\u304c\u63d0\u6848\u3057\u305f\u30bf\u30eb\u30af\u691c\u67fb\u6a19\u6e96\u6cd5\u3002<\/li>\n<\/ul>\n\n\n\n<p><\/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\u304c\u63d0\u6848\u3057\u305f\u30a2\u30ec\u30eb\u30b2\u30f3\u8868\u793a\u306e\u30eb\u30fc\u30eb\u5316<\/li>\n<\/ul>\n\n\n\n<p><\/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>\u30bf\u30eb\u30af\u691c\u67fb\u6a19\u6e96\u6cd5\u304c\u6c7a\u5b9a<\/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\u898f\u5247\u5236\u5b9a\u6848<\/li>\n\n\n\n<li>\u3059\u3079\u3066\u306e\u88fd\u54c1\u306b\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u305f\u8981\u7d20\u8868\u793a<\/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>\u30a2\u30ec\u30eb\u30b2\u30f3\u8868\u793a\u898f\u5236\u304c\u78ba\u5b9a<\/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 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href=\"mailto:%20info@biorius.com\">info@biorius.com<\/a>\u307e\u3067\u76f4\u63a5\u3054\u9023\u7d61\u304f\u3060\u3055\u3044\uff01<\/p>\n","protected":false},"excerpt":{"rendered":"<p>2022\u5e74\u5316\u7ca7\u54c1\u898f\u5236\u8fd1\u4ee3\u5316\u6cd5\uff08MoCRA\uff09 202&#8230;<\/p>\n","protected":false},"author":2,"featured_media":42925,"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":[2410,2409],"tags":[2408,2411,2354,2356,2371],"ppma_author":[2340],"class_list":["post-49563","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cra","category-2409","tag-2408","tag-cra","tag-2354","tag--ja","tag-2371","author-nicolas-lenaersbiorius-com"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - 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