{"id":20507,"date":"2026-06-25T16:14:23","date_gmt":"2026-06-25T08:14:23","guid":{"rendered":"https:\/\/greenoo.tw\/%e7%be%8e%e5%9c%8b%e5%8c%96%e5%a6%9d%e5%93%81-mocra-%e5%92%8c%e5%8f%b0%e7%81%a3%e5%8c%96%e5%a6%9d%e5%93%81%e6%b3%95%e8%a6%8f%e5%b7%ae%e7%95%b0\/"},"modified":"2026-06-25T16:14:23","modified_gmt":"2026-06-25T08:14:23","slug":"%e7%be%8e%e5%9c%8b%e5%8c%96%e5%a6%9d%e5%93%81-mocra-%e5%92%8c%e5%8f%b0%e7%81%a3%e5%8c%96%e5%a6%9d%e5%93%81%e6%b3%95%e8%a6%8f%e5%b7%ae%e7%95%b0","status":"publish","type":"post","link":"https:\/\/greenoo.tw\/en\/%e7%be%8e%e5%9c%8b%e5%8c%96%e5%a6%9d%e5%93%81-mocra-%e5%92%8c%e5%8f%b0%e7%81%a3%e5%8c%96%e5%a6%9d%e5%93%81%e6%b3%95%e8%a6%8f%e5%b7%ae%e7%95%b0\/","title":{"rendered":"\u7f8e\u570b\u5316\u599d\u54c1 MoCRA \u548c\u53f0\u7063\u5316\u599d\u54c1\u6cd5\u898f\u5dee\u7570"},"content":{"rendered":"<article class=\"wp-container\">\n<header class=\"wp-header\">\n<h1>\u7f8e\u570b\u5316\u599d\u54c1 MoCRA \u548c\u53f0\u7063\u5316\u599d\u54c1\u6cd5\u898f\u5dee\u7570<\/h1>\n<div class=\"meta\">ds &middot; 2026-06-25<\/div>\n<\/header>\n<p>    <main class=\"wp-content\"><\/p>\n<p><img decoding=\"async\" alt=\"\u7f8e\u570bMoCRA\u5316\u599d\u54c1\u6cd5\u898f\u8207\u53f0\u7063\u5316\u599d\u54c1\u6cd5\u898f\u5dee\u7570\u6bd4\u8f03\uff0c\u8de8\u5883\u96fb\u5546\u51fa\u53e3\u5408\u898f\u6307\u5357\" src=\"https:\/\/seo-resouce.pandaclaws.ai\/ai-generated-pro\/20260625\/us-mocra-taiwan-cosmetics-regulation-comparison-export-compliance.png?v=1782374479\"><br \/>\n<strong>ALT:<\/strong> \u7f8e\u570bMoCRA\u5316\u599d\u54c1\u6cd5\u898f\u8207\u53f0\u7063\u5316\u599d\u54c1\u6cd5\u898f\u5dee\u7570\uff0c\u53f0\u7063\u8ce3\u5bb6\u8de8\u5883\u51fa\u53e3\u5408\u898f\u91cd\u9ede\u89e3\u6790<\/p>\n<h2 id=\"mocra\">\u53f0\u7063\u5316\u599d\u54c1\u8ce3\u5bb6\u5fc5\u61c2\uff1a\u7f8e\u570b MoCRA \u8207\u53f0\u7063\u5316\u599d\u54c1\u6cd5\u898f\u7684\u95dc\u9375\u5dee\u7570<\/h2>\n<blockquote>\n<p><strong>Key Conclusion<\/strong>::<strong>MoCRA\u53f0\u7063\u5316\u599d\u54c1\u6cd5\u898f<\/strong>\u7684\u5dee\u7570\uff0c\u662f\u6bcf\u4f4d\u6709\u610f\u9032\u8ecd\u7f8e\u570b\u5e02\u5834\u7684\u53f0\u7063\u54c1\u724c\u5fc5\u9808\u6b63\u8996\u7684\u5408\u898f\u8ab2\u984c\u3002\u7f8e\u570b\u300a\u5316\u599d\u54c1\u73fe\u4ee3\u5316\u76e3\u7ba1\u6cd5\u300b\uff08MoCRA\uff09\u65bc2022\u5e74\u5e95\u6b63\u5f0f\u751f\u6548\uff0c\u5927\u5e45\u5f37\u5316\u4e86FDA\u5c0d\u5316\u599d\u54c1\u7684\u76e3\u7ba1\u529b\u5ea6\uff0c\u4e0d\u8ad6\u662f\u8a2d\u65bd\u767b\u8a18\u3001\u7522\u54c1\u5217\u518a\u3001\u5b89\u5168\u8a55\u4f30\u9084\u662f\u4e0d\u826f\u4e8b\u4ef6\u901a\u5831\uff0c\u5747\u8207\u53f0\u7063\u73fe\u884c\u898f\u7bc4\u5b58\u5728\u986f\u8457\u843d\u5dee\u3002\u63d0\u65e9\u4e86\u89e3\u5169\u5957\u6cd5\u898f\u9ad4\u7cfb\u7684\u6838\u5fc3\u5dee\u7570\uff0c\u624d\u80fd\u8b93\u54c1\u724c\u5728\u51fa\u53e3\u5408\u898f\u4e0a\u6436\u5f97\u5148\u6a5f\u3002<\/p>\n<\/blockquote>\n<p>\u7f8e\u570b\u5316\u599d\u54c1\u5e02\u5834\u5e74\u898f\u6a21\u9f90\u5927\uff0c\u9577\u671f\u5438\u5f15\u5168\u7403\u54c1\u724c\u7af6\u76f8\u9032\u5165\u3002\u7136\u800c\uff0c\u904e\u53bb\u7f8e\u570b\u5c0d\u5316\u599d\u54c1\u7684\u76e3\u7ba1\u76f8\u5c0d\u5bec\u9b06\uff0c\u76f4\u52302022\u5e74\u300a\u5316\u599d\u54c1\u73fe\u4ee3\u5316\u76e3\u7ba1\u6cd5\u300b\uff08Modernization of Cosmetics Regulation Act\uff0c\u7c21\u7a31 <strong>MoCRA<\/strong>\uff09\u7684\u9812\u5e03\uff0c\u624d\u8b93\u7f8e\u570b\u5316\u599d\u54c1\u76e3\u7ba1\u6b63\u5f0f\u9081\u5165\u65b0\u6642\u4ee3\u3002<\/p>\n<p>\u5c0d\u53f0\u7063\u8de8\u5883\u8ce3\u5bb6\u800c\u8a00\uff0c\u9019\u4ee3\u8868\u9032\u5165\u7f8e\u570b\u5e02\u5834\u7684\u9580\u6abb\u5df2\u5927\u5e45\u63d0\u9ad8\u3002\u82e5\u4ecd\u4ee5\u53f0\u7063\u7684\u300a\u5316\u7ca7\u54c1\u885b\u751f\u5b89\u5168\u7ba1\u7406\u6cd5\u300b\uff08\u4ee5\u4e0b\u7c21\u7a31\u300c\u53f0\u7063\u5316\u599d\u54c1\u6cd5\u898f\u300d\uff09\u7684\u601d\u7dad\u4f86\u64cd\u4f5c\uff0c\u6975\u53ef\u80fd\u5728\u4e0a\u67b6\u524d\u4fbf\u89f8\u53ca\u5408\u898f\u7d05\u7dda\u3002\u672c\u6587\u5c07\u7cfb\u7d71\u6027\u62c6\u89e3\u5169\u5957\u6cd5\u898f\u7684\u6838\u5fc3\u5dee\u7570\uff0c\u5354\u52a9\u53f0\u7063\u54c1\u724c\u63d0\u524d\u505a\u597d\u6e96\u5099\u3002<\/p>\n<hr>\n<h2 id=\"_1\">\u672c\u6587\u9069\u7528\u60c5\u5883\u8207\u7bc4\u570d<\/h2>\n<p>\u2705 <strong>Applicable scenarios<\/strong>::<\/p>\n<ul>\n<li>\u8a08\u756b\u65bc\u4e9e\u99ac\u905c\u7f8e\u570b\u7ad9\uff08Amazon.com\uff09\u6216\u5176\u4ed6\u7f8e\u570b\u96fb\u5546\u5e73\u53f0\u92b7\u552e\u5316\u599d\u54c1\u7684\u53f0\u7063\u8ce3\u5bb6<\/li>\n<li>\u6b63\u5728\u8a55\u4f30\u54c1\u724c\u51fa\u6d77\u3001\u9700\u8981\u4e86\u89e3\u7f8e\u570b\u5316\u599d\u54c1\u51fa\u53e3\u5408\u898f\u8981\u6c42\u7684\u4e2d\u5c0f\u4f01\u696d\u4e3b<\/li>\n<li>\u4ee3\u7406\u53f0\u7063\u54c1\u724c\u5316\u599d\u54c1\u9032\u5165\u7f8e\u570b\u5e02\u5834\u7684\u9032\u53e3\u5546\u6216\u54c1\u724c\u7d93\u7406<\/li>\n<\/ul>\n<p>\u274c <strong>\u4e0d\u9069\u7528\u60c5\u5883\uff0f\u6ce8\u610f\u4e8b\u9805<\/strong>::<\/p>\n<ul>\n<li>\u50c5\u5728\u53f0\u7063\u672c\u5730\u5e02\u5834\u92b7\u552e\uff0c\u7121\u51fa\u53e3\u8a08\u756b\u7684\u54c1\u724c\uff08\u4f46\u4ecd\u9700\u7b26\u5408\u53f0\u7063\u6cd5\u898f\uff09<\/li>\n<li>\u4ee5\u300c\u85e5\u7528\u5316\u599d\u54c1\u300d\uff08Over-the-Counter Drug\uff09\u7533\u5831\u7684\u7522\u54c1\uff0c\u9808\u53e6\u4f9d FDA \u85e5\u54c1\u6cd5\u898f\u8fa6\u7406\uff0c\u4e0d\u5728\u672c\u6587\u8a0e\u8ad6\u7bc4\u570d<\/li>\n<\/ul>\n<hr>\n<h2 id=\"mocra_1\">\u70ba\u4ec0\u9ebc MoCRA \u5c0d\u53f0\u7063\u5316\u599d\u54c1\u8ce3\u5bb6\u5f71\u97ff\u6df1\u9060<\/h2>\n<p>\u5316\u599d\u54c1\u4e00\u76f4\u662f\u53f0\u7063\u96fb\u5546\u51fa\u53e3\u7684\u91cd\u8981\u54c1\u985e\uff0c\u8209\u51e1\u4fdd\u990a\u54c1\u3001\u5f69\u599d\u3001\u8b77\u9aee\u7522\u54c1\u3001\u9632\u66ec\u4e73\u7b49\uff0c\u5747\u662f\u53f0\u7063\u54c1\u724c\u5728\u4e9e\u99ac\u905c\u4e0a\u7684\u71b1\u92b7\u54c1\u9805\u3002\u7136\u800c\uff0c\u7f8e\u570b\u904e\u53bb\u5c0d\u5316\u599d\u54c1\u7684\u76e3\u7ba1\u9577\u905480\u5e74\u5e7e\u4e4e\u672a\u66fe\u5927\u5e45\u66f4\u65b0\uff0cMoCRA \u7684\u51fa\u73fe\u5fb9\u5e95\u6539\u8b8a\u4e86\u9019\u4e00\u5c40\u9762\u3002<\/p>\n<p>2022\u5e7412\u6708\uff0c\u7f8e\u570b\u7e3d\u7d71\u62dc\u767b\u6b63\u5f0f\u7c3d\u7f72\u300a\u5316\u599d\u54c1\u73fe\u4ee3\u5316\u76e3\u7ba1\u6cd5\u300b\uff0c\u5c07\u5176\u7d0d\u5165\u300a\u806f\u90a6\u98df\u54c1\u3001\u85e5\u54c1\u53ca\u5316\u599d\u54c1\u6cd5\u300b\uff08FD&amp;C Act\uff09\u6846\u67b6\u3002\u9019\u662f\u7f8e\u570b\u5316\u599d\u54c1\u76e3\u7ba1\u53f2\u4e0a\u6700\u91cd\u5927\u7684\u8b8a\u9769\uff0cFDA \u5f9e\u6b64\u64c1\u6709\u66f4\u5f37\u7684\u57f7\u6cd5\u5de5\u5177\uff0c\u5305\u62ec\u5f37\u5236\u53ec\u56de\u3001\u8a2d\u65bd\u67e5\u6838\u3001\u4ee5\u53ca\u5c0d\u4e0d\u826f\u4e8b\u4ef6\u7684\u7cfb\u7d71\u6027\u8ffd\u8e64\u3002<\/p>\n<p>\u76f8\u8f03\u4e4b\u4e0b\uff0c\u53f0\u7063\u81ea2019\u5e74\u65bd\u884c\u7684\u300a\u5316\u7ca7\u54c1\u885b\u751f\u5b89\u5168\u7ba1\u7406\u6cd5\u300b\u96d6\u5df2\u5c6c\u8f03\u73fe\u4ee3\u5316\u7684\u6cd5\u898f\uff0c\u4f46\u5728\u8a31\u591a\u5177\u9ad4\u8981\u6c42\u4e0a\u4ecd\u8207 MoCRA \u5b58\u5728\u7d50\u69cb\u6027\u5dee\u7570\u3002\u9019\u4e9b\u5dee\u7570\u4e0d\u50c5\u9ad4\u73fe\u5728\u7533\u5831\u7a0b\u5e8f\u4e0a\uff0c\u66f4\u6df1\u5165\u5230\u4f01\u696d\u5167\u90e8\u7684\u54c1\u8cea\u7ba1\u7406\u3001\u5b89\u5168\u8a55\u4f30\u6587\u4ef6\uff0c\u4e43\u81f3\u6a19\u7c64\u7684\u6cd5\u5b9a\u683c\u5f0f\u3002<\/p>\n<p>\u503c\u5f97\u4e00\u63d0\u7684\u662f\uff0cMoCRA \u7684\u76e3\u7ba1\u5c0d\u8c61\u4e0d\u50c5\u662f\u7f8e\u570b\u672c\u571f\u88fd\u9020\u5546\uff0c\u53ea\u8981\u7522\u54c1\u5728\u7f8e\u570b\u5883\u5167\u92b7\u552e\u6216\u5411\u7f8e\u570b\u51fa\u53e3\uff0c\u7121\u8ad6\u88fd\u9020\u5546\u4f4d\u65bc\u54ea\u500b\u570b\u5bb6\uff0c\u5747\u9808\u9075\u5b88\u76f8\u95dc\u898f\u5b9a\u3002\u9019\u610f\u5473\u8457\u53f0\u7063\u54c1\u724c\u5373\u4f7f\u900f\u904e\u4e9e\u99ac\u905c FBA \u6a21\u5f0f\u92b7\u552e\uff0c\u4e5f\u96e3\u9003 MoCRA \u7684\u7ba1\u8f44\u7bc4\u570d\u3002<\/p>\n<p>\u6b64\u5916\uff0c\u4e86\u89e3 FDA \u5c0d\u4e0d\u540c\u7522\u54c1\u985e\u5225\u7684\u76e3\u7ba1\u908f\u8f2f\u81f3\u95dc\u91cd\u8981\u3002\u82e5\u60a8\u7684\u54c1\u724c\u540c\u6642\u6d89\u53ca\u98df\u54c1\u6216\u4fdd\u5065\u98df\u54c1\u51fa\u53e3\uff0c\u53ef\u53c3\u8003<a href=\"http:\/\/106.55.224.48\/2026\/06\/24\/%e5%8f%b0%e7%81%a3%e9%a3%9f%e5%93%81%e5%87%ba%e5%8f%a3%e7%be%8e%e5%9c%8b%e9%9c%80%e8%a6%81-fda-%e9%a3%9f%e5%93%81%e8%a8%bb%e5%86%8a%e5%97%8e\/\">\u53f0\u7063\u98df\u54c1\u51fa\u53e3\u7f8e\u570b\u9700\u8981 FDA \u98df\u54c1\u8a3b\u518a\u55ce<\/a>\uff0c\u4ee5\u5168\u9762\u638c\u63e1 FDA \u7684\u6574\u9ad4\u76e3\u7ba1\u67b6\u69cb\u3002<\/p>\n<hr>\n<h2 id=\"mocra_2\">MoCRA \u8207\u53f0\u7063\u5316\u599d\u54c1\u6cd5\u898f\u7684\u6838\u5fc3\u5dee\u7570\u6df1\u5ea6\u89e3\u6790<\/h2>\n<h3 id=\"_2\">\u5feb\u901f\u638c\u63e1\u4e09\u5927\u5408\u898f\u6b65\u9a5f<\/h3>\n<p><strong>\u6b65\u9a5f\u4e00\uff1a\u91d0\u6e05\u7522\u54c1\u662f\u5426\u53d7 MoCRA \u76e3\u7ba1<\/strong><\/p>\n<p>\u9996\u5148\u78ba\u8a8d\u60a8\u7684\u7522\u54c1\u662f\u5426\u7b26\u5408\u7f8e\u570b\u5c0d\u300c\u5316\u599d\u54c1\u300d\u7684\u5b9a\u7fa9\u2014\u2014\u5373\u4ee5\u5857\u62b9\u3001\u64e6\u62ed\u3001\u5674\u7051\u6216\u5176\u4ed6\u65b9\u5f0f\u65bd\u7528\u65bc\u4eba\u9ad4\uff0c\u4ee5\u9054\u5230\u6e05\u6f54\u3001\u7f8e\u5316\u3001\u4fc3\u9032\u5438\u5f15\u529b\u6216\u6539\u8b8a\u5916\u89c0\u70ba\u76ee\u7684\u7684\u7269\u54c1\u3002\u9632\u66ec\u4e73\u3001\u542b\u6c1f\u7259\u818f\u3001\u53bb\u5c51\u6d17\u9aee\u7cbe\u82e5\u540c\u6642\u5177\u6709\u85e5\u7528\u529f\u6548\uff0c\u5247\u53ef\u80fd\u88ab\u6b78\u985e\u70ba OTC \u85e5\u54c1\uff0c\u9069\u7528\u4e0d\u540c\u898f\u7bc4\u3002\u5efa\u8b70\u5728\u6e96\u5099\u7533\u5831\u524d\uff0c\u5148\u9032\u884c\u7522\u54c1\u5206\u985e\u78ba\u8a8d\uff0c\u6b64\u6b65\u9a5f\u901a\u5e38\u9700\u8981\u6578\u5929\u81f3\u6578\u9031\u7684\u8a55\u4f30\u6642\u9593\u3002<\/p>\n<p><strong>\u6b65\u9a5f\u4e8c\uff1a\u5b8c\u6210\u8a2d\u65bd\u767b\u8a18\u8207\u7522\u54c1\u5217\u518a<\/strong><\/p>\n<p>\u78ba\u8a8d\u7522\u54c1\u5c6c\u5316\u599d\u54c1\u7bc4\u7587\u5f8c\uff0c\u88fd\u9020\u6216\u52a0\u5de5\u8a2d\u65bd\u5fc5\u9808\u5411 FDA \u9032\u884c\u8a2d\u65bd\u767b\u8a18\uff08Facility Registration\uff09\uff0c\u4e14\u6bcf\u5169\u5e74\u66f4\u65b0\u4e00\u6b21\u3002\u540c\u6642\uff0c\u5728\u7f8e\u570b\u5e02\u5834\u92b7\u552e\u7684\u6bcf\u6b3e\u5316\u599d\u54c1\u5747\u9808\u5411 FDA \u5b8c\u6210\u7522\u54c1\u5217\u518a\uff08Product Listing\uff09\uff0c\u63d0\u4ea4\u6210\u5206\u6e05\u55ae\u3001\u6a19\u7c64\u5167\u5bb9\u7b49\u8cc7\u8a0a\u3002\u53f0\u7063\u54c1\u724c\u82e5\u900f\u904e\u7f8e\u570b\u9032\u53e3\u5546\u6216\u4e9e\u99ac\u905c FBA \u92b7\u552e\uff0c\u9700\u660e\u78ba\u8207\u8cac\u4efb\u65b9\uff08Responsible Person\uff09\u5354\u8abf\u7531\u8ab0\u8ca0\u8cac\u63d0\u4ea4\u3002<\/p>\n<p><strong>\u6b65\u9a5f\u4e09\uff1a\u5efa\u7acb\u5b89\u5168\u8a55\u4f30\u8207\u4e0d\u826f\u4e8b\u4ef6\u901a\u5831\u6a5f\u5236<\/strong><\/p>\n<p>MoCRA \u8981\u6c42\u8cac\u4efb\u65b9\u5fc5\u9808\u78ba\u4fdd\u6bcf\u6b3e\u5316\u599d\u54c1\u4e0a\u5e02\u524d\u5747\u5df2\u5b8c\u6210\u5b89\u5168\u8a55\u4f30\uff0c\u4e26\u59a5\u5584\u4fdd\u5b58\u76f8\u95dc\u8a18\u9304\u3002\u6b64\u5916\uff0c\u82e5\u7522\u54c1\u8207\u56b4\u91cd\u4e0d\u826f\u4e8b\u4ef6\uff08Serious Adverse Event\uff09\u76f8\u95dc\uff0c\u8cac\u4efb\u65b9\u5fc5\u9808\u5728\u77e5\u6089\u5f8c15\u500b\u5de5\u4f5c\u65e5\u5167\u5411 FDA \u901a\u5831\u3002\u53f0\u7063\u54c1\u724c\u9700\u63d0\u524d\u5efa\u7acb\u76f8\u61c9\u7684\u5167\u90e8\u6d41\u7a0b\uff0c\u78ba\u4fdd\u6709\u80fd\u529b\u5373\u6642\u61c9\u5c0d\u6b64\u985e\u8981\u6c42\u3002<\/p>\n<hr>\n<h3 id=\"mocra_3\">\u7f8e\u570b MoCRA \u8207\u53f0\u7063\u5316\u599d\u54c1\u6cd5\u898f\u4e3b\u8981\u9805\u76ee\u5c0d\u7167<\/h3>\n<p>\u4ee5\u4e0b\u8868\u683c\u6574\u7406\u4e86\u5169\u5957\u6cd5\u898f\u5728\u6838\u5fc3\u76e3\u7ba1\u7dad\u5ea6\u4e0a\u7684\u4e3b\u8981\u5dee\u7570\uff0c\u5354\u52a9\u53f0\u7063\u8ce3\u5bb6\u5feb\u901f\u638c\u63e1\u95dc\u9375\u5408\u898f\u843d\u5dee\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6bd4\u8f03\u7dad\u5ea6<\/th>\n<th>\u7f8e\u570b MoCRA<\/th>\n<th>\u53f0\u7063\u300a\u5316\u7ca7\u54c1\u885b\u751f\u5b89\u5168\u7ba1\u7406\u6cd5\u300b<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u4e3b\u7ba1\u6a5f\u95dc<\/td>\n<td>FDA\uff08\u98df\u54c1\u85e5\u54c1\u7ba1\u7406\u5c40\uff09<\/td>\n<td>\u885b\u751f\u798f\u5229\u90e8\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u7f72\uff08TFDA\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u8a2d\u65bd\u767b\u8a18\u8981\u6c42<\/td>\n<td>\u5f37\u5236\u8a2d\u65bd\u767b\u8a18\uff0c\u6bcf\u5169\u5e74\u66f4\u65b0<\/td>\n<td>\u7121\u5f37\u5236\u8a2d\u65bd\u767b\u8a18\uff08\u88fd\u9020\u696d\u8005\u9700\u7533\u8acb\u8a31\u53ef\uff09<\/td>\n<\/tr>\n<tr>\n<td>\u7522\u54c1\u7533\u5831\u65b9\u5f0f<\/td>\n<td>\u7522\u54c1\u5217\u518a\uff08Product Listing\uff09\uff0c\u4e0d\u9700\u4e0a\u5e02\u524d\u6279\u51c6<\/td>\n<td>\u4e00\u822c\u5316\u599d\u54c1\u5099\u67e5\uff1b\u7279\u5b9a\u7528\u9014\u5316\u599d\u54c1\uff08\u5982\u542b\u85e5\u5316\u599d\u54c1\uff09\u9700\u8a31\u53ef<\/td>\n<\/tr>\n<tr>\n<td>\u5b89\u5168\u8a55\u4f30\u8981\u6c42<\/td>\n<td>\u660e\u78ba\u8981\u6c42\u8cac\u4efb\u65b9\u6301\u6709\u5b89\u5168\u8a55\u4f30\u7d00\u9304<\/td>\n<td>\u696d\u8005\u61c9\u81ea\u884c\u78ba\u4fdd\u7522\u54c1\u5b89\u5168\uff0c\u4f46\u7121\u660e\u6587\u898f\u5b9a\u5b89\u5168\u8a55\u4f30\u6587\u4ef6\u683c\u5f0f<\/td>\n<\/tr>\n<tr>\n<td>Adverse Event Notification<\/td>\n<td>\u56b4\u91cd\u4e0d\u826f\u4e8b\u4ef6\u9808\u65bc15\u500b\u5de5\u4f5c\u65e5\u5167\u901a\u5831<\/td>\n<td>\u7121\u76f8\u540c\u5f37\u5ea6\u7684\u5f37\u5236\u901a\u5831\u6642\u9650\u898f\u7bc4<\/td>\n<\/tr>\n<tr>\n<td>\u6210\u5206\u9650\u5236\u6e05\u55ae<\/td>\n<td>FDA \u7981\u7528\u6210\u5206\u6e05\u55ae\uff08\u542b\u6c5e\u5316\u5408\u7269\u7b49\uff09<\/td>\n<td>TFDA \u5316\u599d\u54c1\u6210\u5206\u57fa\u6e96<\/td>\n<\/tr>\n<tr>\n<td>\u6a19\u7c64\u8a9e\u8a00\u8981\u6c42<\/td>\n<td>\u5fc5\u9808\u4ee5\u82f1\u6587\u6a19\u793a\uff0c\u542b\u8b66\u8a9e<\/td>\n<td>\u9808\u4ee5\u4e2d\u6587\u6a19\u793a\uff0c\u7b26\u5408\u672c\u5730\u6a19\u7c64\u898f\u5b9a<\/td>\n<\/tr>\n<tr>\n<td>\u826f\u597d\u88fd\u9020\u898f\u7bc4\uff08GMP\uff09<\/td>\n<td>FDA \u53ef\u5236\u5b9a\u5316\u599d\u54c1 GMP \u898f\u7bc4\uff08\u9032\u884c\u4e2d\uff09<\/td>\n<td>\u5f37\u5236\u9069\u7528\u5316\u599d\u54c1 GMP \u898f\u7bc4<\/td>\n<\/tr>\n<tr>\n<td>\u5f37\u5236\u53ec\u56de\u6b0a\u529b<\/td>\n<td>FDA \u5177\u5f37\u5236\u53ec\u56de\u5316\u599d\u54c1\u6b0a\u529b<\/td>\n<td>TFDA \u53ef\u547d\u4ee4\u4e0b\u67b6\u6216\u56de\u6536<\/td>\n<\/tr>\n<tr>\n<td>\u9999\u6c1b\u904e\u654f\u539f\u63ed\u9732<\/td>\n<td>\u672a\u4f86\u53ef\u80fd\u8981\u6c42\u7279\u5b9a\u9999\u6c1b\u6210\u5206\u63ed\u9732<\/td>\n<td>\u76ee\u524d\u7121\u5f37\u5236\u9999\u6c1b\u904e\u654f\u539f\u63ed\u9732<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<hr>\n<h3 id=\"_3\">\u6df1\u5165\u89e3\u6790\uff1a\u4e94\u5927\u6838\u5fc3\u5dee\u7570\u9010\u9805\u8aaa\u660e<\/h3>\n<h4 id=\"_4\">\u5dee\u7570\u4e00\uff1a\u7522\u54c1\u5206\u985e\u8207\u76e3\u7ba1\u908a\u754c<\/h4>\n<p><strong>\u53f0\u7063\u5316\u599d\u54c1\u6cd5\u898f<\/strong>\u5c07\u5316\u599d\u54c1\u5206\u70ba\u4e00\u822c\u5316\u599d\u54c1\u8207\u7279\u5b9a\u7528\u9014\u5316\u599d\u54c1\uff08\u5982\u67d3\u9aee\u5291\u3001\u71d9\u9aee\u5291\u3001\u6b62\u6c57\u5236\u81ed\u5291\u3001\u542b\u85e5\u6210\u5206\u7b49\uff09\uff0c\u5f8c\u8005\u9808\u5411 TFDA \u7533\u8acb\u8a31\u53ef\u8b49\u5f8c\u65b9\u53ef\u4e0a\u5e02\u3002\u9019\u6a23\u7684\u96d9\u8ecc\u5236\u5ea6\u76f8\u5c0d\u76f4\u89c0\uff0c\u696d\u8005\u5c0d\u81ea\u8eab\u7522\u54c1\u7684\u7533\u5831\u985e\u5225\u901a\u5e38\u6709\u6e05\u695a\u8a8d\u77e5\u3002<\/p>\n<p><strong>MoCRA<\/strong> \u5247\u63a1\u4e0d\u540c\u908f\u8f2f\uff1a\u591a\u6578\u5316\u599d\u54c1\u4e0d\u9700\u4e0a\u5e02\u524d\u6279\u51c6\uff0c\u4f46\u82e5\u7522\u54c1\u540c\u6642\u5ba3\u7a31\u5177\u6709\u85e5\u7528\u529f\u6548\uff08\u4f8b\u5982\u9632\u66ec\u4fc2\u6578\u3001\u6297\u83cc\u3001\u53bb\u5c51\uff09\uff0c\u5247\u53ef\u80fd\u88ab\u6b78\u985e\u70ba OTC \u85e5\u54c1\uff0c\u5fc5\u9808\u4f9d\u85e5\u54c1\u6cd5\u898f\u63d0\u4ea4 Monograph \u6216 NDA\uff0c\u5408\u898f\u9580\u6abb\u5927\u5e45\u63d0\u9ad8\u3002\u53f0\u7063\u8ce3\u5bb6\u5728\u5236\u5b9a\u7f8e\u570b\u5e02\u5834\u884c\u92b7\u6587\u6848\u6642\uff0c\u5fc5\u9808\u683c\u5916\u5be9\u614e\uff0c\u907f\u514d\u4f7f\u7528\u53ef\u80fd\u89f8\u767c\u300c\u85e5\u54c1\u5ba3\u7a31\u300d\u7684\u63cf\u8ff0\u3002<\/p>\n<h4 id=\"responsible-person\">\u5dee\u7570\u4e8c\uff1a\u8cac\u4efb\u65b9\uff08Responsible Person\uff09\u5236\u5ea6<\/h4>\n<p>MoCRA \u5f15\u5165\u300c<strong>responsible party<\/strong>\uff08Responsible Person\uff09\u300d\u6982\u5ff5\uff0c\u610f\u6307\u5728\u7f8e\u570b\u5883\u5167\u92b7\u552e\u7684\u5316\u599d\u54c1\uff0c\u5fc5\u9808\u6709\u4e00\u500b\u5728\u7f8e\u570b\u5883\u5167\u7684\u8cac\u4efb\u65b9\u2014\u2014\u901a\u5e38\u662f\u88fd\u9020\u5546\u3001\u9032\u53e3\u5546\u6216\u54c1\u724c\u64c1\u6709\u8005\u2014\u2014\u8ca0\u8cac\u5411 FDA \u5b8c\u6210\u8a2d\u65bd\u767b\u8a18\u8207\u7522\u54c1\u5217\u518a\uff0c\u4e26\u627f\u64d4\u4e0d\u826f\u4e8b\u4ef6\u901a\u5831\u7fa9\u52d9\u3002<\/p>\n<p>\u53f0\u7063\u54c1\u724c\u82e5\u76f4\u63a5\u900f\u904e\u4e9e\u99ac\u905c FBA \u5411\u7f8e\u570b\u6d88\u8cbb\u8005\u92b7\u552e\uff0c\u9700\u601d\u8003\u8ab0\u662f\u6cd5\u5f8b\u610f\u7fa9\u4e0a\u7684\u8cac\u4efb\u65b9\u3002\u82e5\u53f0\u7063\u54c1\u724c\u672c\u8eab\u5373\u70ba\u76f4\u63a5\u51fa\u53e3\u5546\u4e14\u7121\u7f8e\u570b\u9032\u53e3\u5546\u4f5c\u70ba\u4e2d\u9593\u65b9\uff0c\u5247\u9700\u8a55\u4f30\u662f\u5426\u9700\u8981\u5728\u7f8e\u570b\u8a2d\u7acb\u4ee3\u7406\u6216\u8207\u5177\u6709\u8cac\u4efb\u65b9\u8cc7\u683c\u7684\u5408\u4f5c\u65b9\u5408\u4f5c\u3002\u9019\u4e00\u9ede\u5728 FDA \u98df\u54c1\u76e3\u7ba1\u4e2d\u7684\u7f8e\u570b\u4ee3\u7406\u4eba\u5236\u5ea6\u4ea6\u6709\u985e\u4f3c\u8003\u91cf\uff0c\u5efa\u8b70\u8ce3\u5bb6\u540c\u6b65\u4e86\u89e3<a href=\"https:\/\/greenoo.tw\/en\/fda-%e9%a3%9f%e5%93%81%e8%a8%bb%e5%86%8a%e5%92%8c-fsvp-%e6%9c%89%e4%bb%80%e9%ba%bc%e4%b8%8d%e5%90%8c\/\">FDA \u98df\u54c1\u8a3b\u518a\u548c FSVP \u6709\u4ec0\u9ebc\u4e0d\u540c<\/a>\uff0c\u4ee5\u7406\u89e3 FDA \u8de8\u54c1\u985e\u76e3\u7ba1\u5c0d\u4ee3\u7406\u4eba\u89d2\u8272\u7684\u4e00\u81f4\u6027\u8981\u6c42\u3002<\/p>\n<h4 id=\"_5\">\u5dee\u7570\u4e09\uff1a\u5b89\u5168\u8a55\u4f30\u6587\u4ef6\u7684\u8981\u6c42\u6df1\u5ea6<\/h4>\n<p>\u53f0\u7063\u6cd5\u898f\u8981\u6c42\u696d\u8005\u78ba\u4fdd\u7522\u54c1\u5b89\u5168\uff0c\u4e26\u5728\u5e02\u5834\u6aa2\u67e5\u6642\u80fd\u63d0\u4f9b\u76f8\u95dc\u8cc7\u6599\uff0c\u4f46\u4e26\u672a\u660e\u78ba\u898f\u7bc4\u5b89\u5168\u8a55\u4f30\u5831\u544a\u7684\u5177\u9ad4\u683c\u5f0f\u6216\u5fc5\u8981\u9805\u76ee\u3002\u8a31\u591a\u53f0\u7063\u4e2d\u5c0f\u578b\u54c1\u724c\u4f9d\u8cf4\u539f\u6599\u4f9b\u61c9\u5546\u63d0\u4f9b\u7684\u6210\u5206\u5b89\u5168\u8cc7\u6599\uff0c\u7f3a\u4e4f\u7cfb\u7d71\u6027\u7684\u6574\u9ad4\u7522\u54c1\u5b89\u5168\u8a55\u4f30\u6587\u4ef6\u3002<\/p>\n<p>MoCRA \u5247\u660e\u78ba\u8981\u6c42\u8cac\u4efb\u65b9\u300c\u6301\u6709\u5145\u5206\u7684\u5b89\u5168\u8a55\u4f30\u7d00\u9304\u300d\uff08adequate substantiation of safety\uff09\u3002\u96d6\u7136 FDA \u76ee\u524d\u4ecd\u5728\u5236\u5b9a\u5177\u9ad4\u7684\u5b89\u5168\u8a55\u4f30\u898f\u7bc4\u7d30\u5247\uff0c\u4f46\u5408\u898f\u539f\u5247\u5df2\u5341\u5206\u6e05\u6670\uff1a\u696d\u8005\u5fc5\u9808\u80fd\u5920\u8209\u8b49\u7522\u54c1\u7684\u5b89\u5168\u6027\uff0c\u800c\u975e\u50c5\u4f9d\u8cf4\u6210\u5206\u4f9b\u61c9\u5546\u7684\u8072\u660e\u3002\u9019\u5c0d\u53f0\u7063\u54c1\u724c\u7684\u7522\u54c1\u958b\u767c\u6d41\u7a0b\u63d0\u51fa\u4e86\u66f4\u9ad8\u8981\u6c42\u3002<\/p>\n<h4 id=\"_6\">\u5dee\u7570\u56db\uff1a\u4e0d\u826f\u4e8b\u4ef6\u901a\u5831\u7fa9\u52d9<\/h4>\n<p>\u53f0\u7063\u73fe\u884c\u6cd5\u898f\u5c0d\u5316\u599d\u54c1\u4e0d\u826f\u4e8b\u4ef6\u901a\u5831\u7684\u5f37\u5236\u6027\u8981\u6c42\u76f8\u5c0d\u6709\u9650\uff0c\u696d\u8005\u901a\u5e38\u900f\u904e\u81ea\u9858\u901a\u5831\u6a5f\u5236\u6216\u885b\u751f\u4e3b\u7ba1\u6a5f\u95dc\u555f\u52d5\u8abf\u67e5\u5f8c\u65b9\u9032\u884c\u914d\u5408\u3002<\/p>\n<p>MoCRA \u5247\u5efa\u7acb\u4e86\u5f37\u5236\u901a\u5831\u5236\u5ea6\uff1a\u82e5\u8cac\u4efb\u65b9\u6536\u5230\u8207\u7522\u54c1\u76f8\u95dc\u7684\u56b4\u91cd\u4e0d\u826f\u4e8b\u4ef6\uff08\u5982\u4f4f\u9662\u3001\u56b4\u91cd\u904e\u654f\u53cd\u61c9\u3001\u6bc0\u5bb9\u7b49\uff09\uff0c\u5fc5\u9808\u5728\u77e5\u6089\u5f8c<strong>15\u500b\u5de5\u4f5c\u65e5<\/strong>\u5167\u5411 FDA \u63d0\u4ea4\u5b8c\u6574\u5831\u544a\uff0c\u4e14\u9808\u4fdd\u5b58\u76f8\u95dc\u7d00\u9304\u81f3\u5c116\u5e74\u3002\u9019\u5c0d\u53f0\u7063\u54c1\u724c\u7684\u5ba2\u670d\u6d41\u7a0b\u3001\u6d88\u8cbb\u8005\u6295\u8a34\u8655\u7406\u6a5f\u5236\u5747\u5e36\u4f86\u76f4\u63a5\u5f71\u97ff\uff0c\u4f01\u696d\u5fc5\u9808\u63d0\u524d\u5efa\u7acb\u76f8\u61c9\u7684\u5167\u90e8\u7ba1\u7406\u5236\u5ea6\u3002<\/p>\n<h4 id=\"gmp\">\u5dee\u7570\u4e94\uff1a\u826f\u597d\u88fd\u9020\u898f\u7bc4\uff08GMP\uff09\u7684\u5be6\u65bd\u9032\u7a0b<\/h4>\n<p>\u53f0\u7063\u81ea2019\u5e74\u8d77\u5f37\u5236\u8981\u6c42\u5316\u599d\u54c1\u88fd\u9020\u5546\u7b26\u5408\u570b\u5167\u5316\u599d\u54c1 GMP \u898f\u7bc4\uff08\u4f9d\u88fd\u9020\u5546\u898f\u6a21\u5206\u968e\u6bb5\u5be6\u65bd\uff09\uff0c\u53ef\u8aaa\u662f\u5728 GMP \u5f37\u5236\u5316\u65b9\u9762\u8d70\u5728\u524d\u9762\u3002<\/p>\n<p>\u7f8e\u570b\u65b9\u9762\uff0cMoCRA \u6388\u6b0a FDA \u5236\u5b9a\u5316\u599d\u54c1 GMP \u898f\u7bc4\uff0c\u4f46\u76f8\u95dc\u7d30\u5247\u4ecd\u5728\u7814\u8b70\u4e2d\uff0c\u76ee\u524d\u5c1a\u672a\u6b63\u5f0f\u5f37\u5236\u5be6\u65bd\u3002\u53f0\u7063\u54c1\u724c\u82e5\u5df2\u7b26\u5408\u53f0\u7063 GMP \u8981\u6c42\uff0c\u5728\u63a5\u8ecc\u672a\u4f86\u7f8e\u570b GMP \u898f\u7bc4\u6642\u53ef\u80fd\u5177\u6709\u4e00\u5b9a\u57fa\u790e\u512a\u52e2\uff0c\u4f46\u4ecd\u9700\u7559\u610f\u5169\u5957\u898f\u7bc4\u5728\u5177\u9ad4\u8981\u6c42\u4e0a\u7684\u6f5b\u5728\u5dee\u7570\u3002<\/p>\n<p><img decoding=\"async\" alt=\"\u7f8e\u570bMoCRA\u5316\u599d\u54c1\u8a2d\u65bd\u767b\u8a18\u8207\u7522\u54c1\u5217\u518a\u6d41\u7a0b\u5716\uff0c\u5354\u52a9\u53f0\u7063\u54c1\u724c\u638c\u63e1\u51fa\u53e3\u5408\u898f\u6b65\u9a5f\" src=\"https:\/\/seo-resouce.pandaclaws.ai\/ai-generated-pro\/20260625\/mocra-facility-registration-product-listing-compliance-steps.png?v=1782374479\"><br \/>\n<strong>ALT:<\/strong> \u7f8e\u570bMoCRA\u5316\u599d\u54c1\u8a2d\u65bd\u767b\u8a18\u7522\u54c1\u5217\u518a\u6d41\u7a0b\uff0c\u53f0\u7063\u8de8\u5883\u96fb\u5546\u51fa\u53e3\u7f8e\u570b\u5316\u599d\u54c1\u5408\u898f\u6b65\u9a5f\u8aaa\u660e<\/p>\n<hr>\n<h2 id=\"_7\">\u9032\u968e\u5408\u898f\u8981\u9ede\uff1a\u7279\u6b8a\u60c5\u5883\u8207\u5e38\u898b\u8aa4\u89e3<\/h2>\n<h3 id=\"_8\">\u7279\u6b8a\u60c5\u5883\u4e00\uff1a\u542b\u9632\u66ec\u6210\u5206\u7684\u8b77\u819a\u54c1<\/h3>\n<p>\u9632\u66ec\u7522\u54c1\u5728\u7f8e\u570b\u88ab\u6b78\u985e\u70ba OTC \u85e5\u54c1\uff0c\u800c\u975e\u55ae\u7d14\u7684\u5316\u599d\u54c1\u3002\u9019\u610f\u5473\u8457\u542b\u6709 SPF \u5ba3\u7a31\u7684\u8b77\u819a\u54c1\u3001BB \u971c\u3001\u57fa\u790e\u599d\u5bb9\u7b49\uff0c\u5373\u4f7f\u5728\u53f0\u7063\u4ee5\u5316\u599d\u54c1\u8eab\u4efd\u4e0a\u5e02\uff0c\u9032\u5165\u7f8e\u570b\u5e02\u5834\u6642\u9808\u4f9d OTC \u85e5\u54c1 Monograph \u8fa6\u7406\uff0c\u5305\u62ec\u7279\u5b9a\u6210\u5206\u6fc3\u5ea6\u9650\u5236\u3001\u6a19\u7c64\u683c\u5f0f\u8981\u6c42\u7b49\uff0c\u5408\u898f\u96e3\u5ea6\u9060\u9ad8\u65bc\u4e00\u822c\u5316\u599d\u54c1\u3002\u53f0\u7063\u54c1\u724c\u5728\u898f\u5283\u7f8e\u570b\u7522\u54c1\u7dda\u6642\uff0c\u5efa\u8b70\u63d0\u524d\u79fb\u9664\u6216\u8abf\u6574 SPF \u5ba3\u7a31\uff0c\u6216\u53e6\u884c\u898f\u5283 OTC \u7533\u5831\u8def\u5f91\u3002<\/p>\n<h3 id=\"_9\">\u7279\u6b8a\u60c5\u5883\u4e8c\uff1a\u5c0f\u578b\u88fd\u9020\u5546\u7684\u904e\u6e21\u5b89\u6392<\/h3>\n<p>MoCRA \u5c0d\u5e74\u92b7\u552e\u984d\u4f4e\u65bc\u4e00\u5b9a\u9580\u6abb\u7684\u5c0f\u578b\u4f01\u696d\u8a2d\u6709\u90e8\u5206\u8c41\u514d\u6216\u5bec\u9650\u671f\uff0c\u4f8b\u5982\u5728\u8a2d\u65bd\u767b\u8a18\u8981\u6c42\u4e0a\u3002\u7136\u800c\uff0c\u53f0\u7063\u8ce3\u5bb6\u9700\u6ce8\u610f\uff0c\u8c41\u514d\u8cc7\u683c\u7684\u5224\u5b9a\u662f\u4ee5\u300c\u5728\u7f8e\u570b\u5883\u5167\u92b7\u552e\u7684\u5316\u599d\u54c1\u5e74\u5ea6\u6de8\u92b7\u552e\u984d\u300d\u70ba\u57fa\u790e\uff0c\u800c\u975e\u4f01\u696d\u6574\u9ad4\u898f\u6a21\uff0c\u4e14\u76f8\u95dc\u8a8d\u5b9a\u6a19\u6e96\u4ecd\u6709\u5f85 FDA \u9032\u4e00\u6b65\u91d0\u6e05\u3002\u5207\u52ff\u81ea\u884c\u5047\u8a2d\u7b26\u5408\u8c41\u514d\u689d\u4ef6\uff0c\u5efa\u8b70\u8aee\u8a62\u5c08\u696d\u9867\u554f\u78ba\u8a8d\u3002<\/p>\n<h3 id=\"oem\">\u7279\u6b8a\u60c5\u5883\u4e09\uff1a\u4ee3\u5de5\u54c1\u724c\u8207 OEM \u5408\u4f5c\u6a21\u5f0f<\/h3>\n<p>\u8a31\u591a\u53f0\u7063\u54c1\u724c\u63a1 OEM \u6216 ODM \u6a21\u5f0f\u751f\u7522\uff0c\u7522\u54c1\u5be6\u969b\u7531\u4ee3\u5de5\u5ee0\u88fd\u9020\u3002\u5728 MoCRA \u6846\u67b6\u4e0b\uff0c\u88fd\u9020\u8a2d\u65bd\u672c\u8eab\u5373\u9700\u9032\u884c\u767b\u8a18\uff0c\u8cac\u4efb\u65b9\u4e5f\u9700\u78ba\u4fdd\u4ee3\u5de5\u5ee0\u7b26\u5408\u76f8\u95dc\u8981\u6c42\u3002\u53f0\u7063\u8ce3\u5bb6\u5728\u8207\u4ee3\u5de5\u5ee0\u5408\u4f5c\u6642\uff0c\u61c9\u5728\u5408\u7d04\u4e2d\u660e\u78ba\u7d04\u5b9a\u5408\u898f\u8cac\u4efb\u7684\u5206\u914d\uff0c\u4e26\u78ba\u8a8d\u4ee3\u5de5\u5ee0\u662f\u5426\u9858\u610f\u914d\u5408\u9032\u884c\u5fc5\u8981\u7684\u8a2d\u65bd\u767b\u8a18\u3002\u82e5\u5c0d\u7533\u5831\u8cc7\u6599\u6e96\u5099\u6709\u7591\u554f\uff0c\u53ef\u53c3\u8003 FDA \u76f8\u95dc\u7533\u5831\u7684<a href=\"https:\/\/greenoo.tw\/en\/%e9%a3%9f%e5%93%81%e5%93%81%e7%89%8c%e7%ac%ac%e4%b8%80%e6%ac%a1%e9%80%b2%e7%be%8e%e5%9c%8b%e5%b8%82%e5%a0%b4%e8%a9%b2%e6%80%8e%e9%ba%bc%e8%99%95%e7%90%86-fda\/\">\u98df\u54c1\u54c1\u724c\u7b2c\u4e00\u6b21\u9032\u7f8e\u570b\u5e02\u5834\u8a72\u600e\u9ebc\u8655\u7406 FDA<\/a>\u4e2d\u95dc\u65bc\u521d\u6b21\u9762\u5c0d FDA \u7533\u5831\u7684\u5be6\u52d9\u5efa\u8b70\uff0c\u908f\u8f2f\u67b6\u69cb\u53ef\u4f9b\u53c3\u8003\u3002<\/p>\n<h3 id=\"_10\">\u5e38\u898b\u8aa4\u89e3\u6f84\u6e05<\/h3>\n<p><strong>\u8aa4\u89e3\uff1a\u300c\u53ea\u8981\u7522\u54c1\u5728\u53f0\u7063\u5408\u6cd5\u4e0a\u5e02\uff0c\u5c31\u53ef\u4ee5\u76f4\u63a5\u5728\u7f8e\u570b\u92b7\u552e\u3002\u300d<\/strong><br \/>\n\u9019\u662f\u6700\u5371\u96aa\u7684\u8aa4\u89e3\u3002\u53f0\u7063\u5408\u898f\u8207\u7f8e\u570b MoCRA \u5408\u898f\u662f\u5169\u5957\u5b8c\u5168\u7368\u7acb\u7684\u8981\u6c42\uff0c\u4e92\u4e0d\u66ff\u4ee3\u3002\u53f0\u7063\u8a31\u53ef\u4e0d\u4ee3\u8868\u7f8e\u570b\u5408\u898f\uff0c\u53cd\u4e4b\u4ea6\u7136\u3002<\/p>\n<p><strong>\u8aa4\u89e3\uff1a\u300c\u4e9e\u99ac\u905c\u6703\u5e6b\u6211\u8655\u7406\u5408\u898f\u554f\u984c\u3002\u300d<\/strong><br \/>\n\u4e9e\u99ac\u905c\u5e73\u53f0\u53ef\u80fd\u6703\u8981\u6c42\u8ce3\u5bb6\u63d0\u4ea4\u5408\u898f\u6587\u4ef6\uff0c\u4f46\u5e73\u53f0\u672c\u8eab\u4e0d\u627f\u64d4\u88fd\u9020\u5546\u6216\u54c1\u724c\u65b9\u7684\u6cd5\u5f8b\u5408\u898f\u8cac\u4efb\u3002FDA \u7684\u57f7\u6cd5\u5c0d\u8c61\u662f\u8cac\u4efb\u65b9\uff0c\u800c\u975e\u96fb\u5546\u5e73\u53f0\u3002<\/p>\n<hr>\n<h2 id=\"faq\">Frequently Asked Questions FAQ<\/h2>\n<h3 id=\"q1-fda-mocra\">Q1\uff1a\u53f0\u7063\u5316\u599d\u54c1\u54c1\u724c\u5982\u4f55\u5224\u65b7\u81ea\u5df1\u662f\u5426\u9700\u8981\u5411 FDA \u9032\u884c MoCRA \u8a2d\u65bd\u767b\u8a18\uff1f<\/h3>\n<p>\u53ea\u8981\u60a8\u7684\u88fd\u9020\u6216\u52a0\u5de5\u8a2d\u65bd\u53c3\u8207\u4e86\u5728\u7f8e\u570b\u5883\u5167\u92b7\u552e\u7684\u5316\u599d\u54c1\u4e4b\u88fd\u9020\u3001\u52a0\u5de5\u3001\u5305\u88dd\u6216\u4fdd\u5b58\uff0c\u901a\u5e38\u5373\u9808\u9032\u884c\u8a2d\u65bd\u767b\u8a18\u3002\u5373\u4f7f\u60a8\u7684\u5de5\u5ee0\u4f4d\u65bc\u53f0\u7063\uff0c\u53ea\u8981\u7522\u54c1\u6700\u7d42\u5728\u7f8e\u570b\u4e0a\u5e02\uff0c\u5373\u53d7 MoCRA \u7ba1\u8f44\u3002\u5efa\u8b70\u54c1\u724c\u5728\u78ba\u8a8d\u7f8e\u570b\u5e02\u5834\u92b7\u552e\u8a08\u756b\u5f8c\uff0c\u7acb\u5373\u8aee\u8a62\u5c08\u696d\u5408\u898f\u9867\u554f\uff0c\u78ba\u8a8d\u767b\u8a18\u7fa9\u52d9\u8207\u6642\u7a0b\uff0c\u4ee5\u514d\u932f\u904e FDA \u898f\u5b9a\u7684\u767b\u8a18\u671f\u9650\u3002<\/p>\n<h3 id=\"q2mocra\">Q2\uff1aMoCRA \u4e0b\u7684\u7522\u54c1\u5217\u518a\u662f\u5426\u7b49\u540c\u65bc\u53f0\u7063\u7684\u5316\u599d\u54c1\u5099\u67e5\uff1f<\/h3>\n<p>\u5169\u8005\u6982\u5ff5\u985e\u4f3c\uff08\u5747\u70ba\u4e8b\u524d\u7533\u5831\u3001\u975e\u4e0a\u5e02\u524d\u5be9\u6279\uff09\uff0c\u4f46\u8981\u6c42\u7d30\u7bc0\u4e0d\u540c\u3002\u53f0\u7063\u5099\u67e5\u9700\u63d0\u4ea4\u7522\u54c1\u6210\u5206\u3001\u88fd\u9020\u8cc7\u8a0a\u7b49\uff1bMoCRA \u7522\u54c1\u5217\u518a\u540c\u6a23\u9700\u7533\u5831\u6210\u5206\uff08\u542b\u529f\u80fd\u7528\u9014\uff09\u3001\u6a19\u7c64\u8cc7\u8a0a\u3001\u88fd\u9020\u8a2d\u65bd\u7b49\uff0c\u4e14\u9996\u6b21\u4e0a\u5e02\u5f8c\u9808\u6bcf\u5e74\u66f4\u65b0\u3002\u6b64\u5916\uff0cMoCRA \u7522\u54c1\u5217\u518a\u662f\u7531\u300c\u8cac\u4efb\u65b9\u300d\u63d0\u4ea4\uff0c\u800c\u8cac\u4efb\u65b9\u5fc5\u9808\u70ba\u5728\u7f8e\u5883\u5167\u7684\u6cd5\u5f8b\u4e3b\u9ad4\u6216\u5176\u6388\u6b0a\u4ee3\u7406\u4eba\uff0c\u9019\u8207\u53f0\u7063\u5099\u67e5\u7531\u88fd\u9020\u5546\u6216\u9032\u53e3\u5546\u63d0\u4ea4\u7684\u65b9\u5f0f\u6709\u6240\u4e0d\u540c\u3002<\/p>\n<h3 id=\"q3-mocra\">Q3\uff1a\u53f0\u7063\u5316\u599d\u54c1\u54c1\u724c\u9032\u884c MoCRA \u5408\u898f\u9700\u8981\u82b1\u591a\u5c11\u6642\u9593\u8207\u6210\u672c\uff1f<\/h3>\n<p>\u5408\u898f\u6240\u9700\u6642\u9593\u8207\u6210\u672c\u56e0\u54c1\u724c\u898f\u6a21\u3001\u7522\u54c1\u6578\u91cf\u53ca\u73fe\u6709\u6587\u4ef6\u5b8c\u6574\u5ea6\u800c\u7570\uff0c\u7121\u6cd5\u63d0\u4f9b\u7d71\u4e00\u6578\u5b57\u3002\u4e00\u822c\u800c\u8a00\uff0c\u8a2d\u65bd\u767b\u8a18\u672c\u8eab\u900f\u904e FDA \u96fb\u5b50\u7cfb\u7d71\uff08SPL\uff09\u63d0\u4ea4\u76f8\u5c0d\u5feb\u901f\uff0c\u4f46\u5b89\u5168\u8a55\u4f30\u6587\u4ef6\u7684\u5efa\u7acb\u3001\u6210\u5206\u5be9\u67e5\u3001\u6a19\u7c64\u8abf\u6574\u7b49\u524d\u7f6e\u4f5c\u696d\u53ef\u80fd\u9700\u8981\u6578\u9031\u81f3\u6578\u6708\u4e0d\u7b49\u3002\u5efa\u8b70\u54c1\u724c\u53ca\u65e9\u555f\u52d5\u8a55\u4f30\u6d41\u7a0b\uff0c\u4e26\u8003\u616e\u59d4\u8a17\u5177\u6709 MoCRA \u7533\u5831\u7d93\u9a57\u7684\u5c08\u696d\u9867\u554f\u5354\u52a9\uff0c\u4ee5\u78ba\u4fdd\u6587\u4ef6\u5b8c\u6574\u6027\u4e26\u7e2e\u77ed\u5408\u898f\u6642\u7a0b\u3002<\/p>\n<hr>\n<h2 id=\"_11\">Conclusion<\/h2>\n<p>\u56de\u9867\u672c\u6587\u7684\u6838\u5fc3\u91cd\u9ede\uff0c<strong>MoCRA\u53f0\u7063\u5316\u599d\u54c1\u6cd5\u898f<\/strong>\u4e4b\u9593\u7684\u5dee\u7570\u6db5\u84cb\u591a\u500b\u95dc\u9375\u7dad\u5ea6\uff0c\u53f0\u7063\u54c1\u724c\u5fc5\u9808\u5f9e\u4e09\u500b\u5c64\u9762\u63a1\u53d6\u884c\u52d5\uff1a<\/p>\n<p><strong>\u7b2c\u4e00\uff0c\u5efa\u7acb\u6b63\u78ba\u8a8d\u77e5<\/strong>\uff1aMoCRA \u662f\u7368\u7acb\u65bc\u53f0\u7063\u6cd5\u898f\u7684\u5168\u65b0\u8981\u6c42\uff0c\u53f0\u7063\u5408\u898f\u6587\u4ef6\u7121\u6cd5\u76f4\u63a5\u66ff\u4ee3\u7f8e\u570b\u7533\u5831\uff0c\u5169\u5957\u6cd5\u898f\u9700\u5206\u5225\u61c9\u5c0d\u3002<\/p>\n<p><strong>\u7b2c\u4e8c\uff0c\u63d0\u524d\u898f\u5283\u5408\u898f\u6d41\u7a0b<\/strong>\uff1a\u8a2d\u65bd\u767b\u8a18\u3001\u7522\u54c1\u5217\u518a\u3001\u5b89\u5168\u8a55\u4f30\u6587\u4ef6\u3001\u4e0d\u826f\u4e8b\u4ef6\u901a\u5831\u6a5f\u5236\u2014\u2014\u9019\u56db\u5927\u6838\u5fc3\u8981\u6c42\u9700\u8981\u6642\u9593\u5efa\u7acb\uff0c\u8d8a\u65e9\u555f\u52d5\uff0c\u8d8a\u80fd\u5f9e\u5bb9\u61c9\u5c0d FDA \u57f7\u6cd5\u3002<\/p>\n<p><strong>\u7b2c\u4e09\uff0c\u91cd\u8996\u7f8e\u570b\u5316\u599d\u54c1\u6cd5\u898f\u7684\u52d5\u614b\u66f4\u65b0<\/strong>\uff1aMoCRA \u7684\u914d\u5957\u7d30\u5247\uff08\u5982 GMP \u898f\u7bc4\u3001\u9999\u6c1b\u6210\u5206\u63ed\u9732\u8981\u6c42\uff09\u4ecd\u5728\u9678\u7e8c\u5236\u5b9a\u4e2d\uff0c\u53f0\u7063\u54c1\u724c\u9700\u6301\u7e8c\u8ffd\u8e64 FDA \u6700\u65b0\u516c\u544a\uff0c\u907f\u514d\u56e0\u5ffd\u7565\u6cd5\u898f\u66f4\u65b0\u800c\u9020\u6210\u5408\u898f\u7f3a\u53e3\u3002<\/p>\n<p>\u8de8\u5883\u96fb\u5546\u7684\u7af6\u722d\u5f9e\u4f86\u4e0d\u53ea\u662f\u7522\u54c1\u529b\u7684\u6bd4\u62fc\uff0c\u5408\u898f\u80fd\u529b\u624d\u662f\u54c1\u724c\u9577\u671f\u5728\u6d77\u5916\u5e02\u5834\u7acb\u8db3\u7684\u57fa\u77f3\u3002\u9762\u5c0d\u7f8e\u570b\u5316\u599d\u54c1\u5e02\u5834\u7684\u65b0\u76e3\u7ba1\u74b0\u5883\uff0c\u63d0\u65e9\u884c\u52d5\u3001\u5c08\u696d\u61c9\u5c0d\uff0c\u624d\u662f\u8b93\u54c1\u724c\u6c38\u7e8c\u51fa\u6d77\u7684\u6700\u4f73\u7b56\u7565\u3002<\/p>\n<p>\u60f3\u8b93\u54c1\u724c\u9806\u5229\u51fa\u6d77\u3001\u9060\u96e2\u5408\u898f\u98a8\u96aa\uff1f<strong>\u7da0\u5708\u5708 Greenoo<\/strong> \u64c1\u6709\u6a6b\u8de8\u7f8e\u570b\u3001\u65e5\u672c\u3001\u6b50\u76df\u53ca\u4e2d\u570b\u7684\u8de8\u5883\u96fb\u5546\u5408\u898f\u5c08\u5bb6\u5718\u968a\uff0c\u5f9e VAT\u3001EPR\u3001FDA \u5230\u5b89\u898f\u8a8d\u8b49\uff0c\u63d0\u4f9b\u5168\u65b9\u4f4d\u4e00\u7ad9\u5f0f\u652f\u63f4\u3002\u7acb\u5373\u524d\u5f80 <a href=\"https:\/\/greenoo.tw\/en\/\">https:\/\/greenoo.tw\/<\/a>\uff0c\u8b93\u5c08\u696d\u9867\u554f\u70ba\u60a8\u91cf\u8eab\u6253\u9020\u51fa\u6d77\u5408\u898f\u7b56\u7565\uff0c\u52a9\u60a8\u54c1\u724c\u81ea\u4fe1\u8d70\u5411\u4e16\u754c\uff01<\/p>\n<hr>\n<h2 id=\"_12\">\u53c3\u8003\u8cc7\u6599<\/h2>\n<ol>\n<li>U.S. Food &amp; Drug Administration. &#8220;Modernization of Cosmetics Regulation Act of 2022 (MoCRA)&#8221;.<br \/>\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-laws-regulations\/modernization-cosmetics-regulation-act-2022-mocra\" rel=\"nofollow noopener\" target=\"_blank\">https:\/\/www.fda.gov\/cosmetics\/cosmetics-laws-regulations\/modernization-cosmetics-regulation-act-2022-mocra<\/a><\/li>\n<li>U.S. Food &amp; Drug Administration. &#8220;Cosmetic Product Facility Registration and Cosmetic Product Listing&#8221;.<br \/>\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/registration-listing-cosmetic-product-facilities-and-products\" rel=\"nofollow noopener\" target=\"_blank\">https:\/\/www.fda.gov\/cosmetics\/registration-listing-cosmetic-product-facilities-and-products<\/a><\/li>\n<li>\u885b\u751f\u798f\u5229\u90e8\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u7f72. \u300c\u5316\u7ca7\u54c1\u885b\u751f\u5b89\u5168\u7ba1\u7406\u6cd5\u300d.<br \/>\n<a href=\"https:\/\/www.fda.gov.tw\/TC\/site.aspx?sid=11215\" rel=\"nofollow noopener\" target=\"_blank\">https:\/\/www.fda.gov.tw\/TC\/site.aspx?sid=11215<\/a><\/li>\n<li>U.S. Food &amp; Drug Administration. &#8220;OTC (Nonprescription) Drug Products&#8221;.<br \/>\n<a href=\"https:\/\/www.fda.gov\/drugs\/drug-approvals-and-databases\/otc-nonprescription-drug-products\" rel=\"nofollow noopener\" target=\"_blank\">https:\/\/www.fda.gov\/drugs\/drug-approvals-and-databases\/otc-nonprescription-drug-products<\/a><\/li>\n<li>U.S. Congress. &#8220;Consolidated Appropriations Act, 2023 \u2013 MoCRA Full Text&#8221;.<br \/>\n<a href=\"https:\/\/www.congress.gov\/bill\/117th-congress\/house-bill\/2617\" rel=\"nofollow noopener\" target=\"_blank\">https:\/\/www.congress.gov\/bill\/117th-congress\/house-bill\/2617<\/a><\/li>\n<\/ol>\n<p><em>\u6ce8\u610f\uff1a\u6a19\u6e96\u53ef\u80fd\u96a8\u6642\u66f4\u65b0\uff0c\u8acb\u67e5\u95b1\u6700\u65b0\u5b98\u65b9\u6587\u4ef6\u6216\u8aee\u8a62\u5c08\u696d\u9867\u554f\u3002<\/em><\/p>\n<hr>\n<hr>\n<p><strong>\u95dc\u65bc Greenoo \u7da0\u5708\u5708<\/strong><\/p>\n<p>\u7da0\u5708\u5708\uff08Greenoo\uff09\u662f\u53f0\u7063\u5c08\u696d\u7684\u4e9e\u99ac\u905c\u8de8\u5883\u96fb\u5546\u958b\u5e97\u5408\u898f\u670d\u52d9\u5e73\u53f0\uff0c\u7531\u7f8e\u570b\u3001\u65e5\u672c\u3001\u6b50\u76df\u53ca\u4e2d\u570b\u8de8\u5883\u96fb\u5546\u5c08\u5bb6\u5718\u968a\u7d44\u6210\uff0c\u63d0\u4f9b VAT\u3001EPR\u3001FDA\u3001\u5b89\u898f\u8a8d\u8b49\u53ca\u6c23\u5019\u53cb\u597d\u8a08\u5283\u7b49\u4e00\u7ad9\u5f0f\u5408\u898f\u670d\u52d9\uff0c\u81f4\u529b\u5354\u52a9\u53f0\u7063\u8ce3\u5bb6\u54c1\u724c\u5408\u898f\u51fa\u6d77\u3002\u5b98\u65b9\u7db2\u7ad9\uff1a<a href=\"https:\/\/greenoo.tw\/en\/\">https:\/\/greenoo.tw\/<\/a><\/p>\n<blockquote>\n<p>\u672c\u6587\u7531 Greenoo \u7da0\u5708\u5708\u5167\u5bb9\u5718\u968a\u7de8\u64b0\uff0c\u5167\u5bb9\u50c5\u4f9b\u53c3\u8003\uff0c\u4e0d\u69cb\u6210\u4efb\u4f55\u6cd5\u5f8b\u6216\u7a05\u52d9\u5efa\u8b70\u3002\u6cd5\u898f\u653f\u7b56\u53ef\u80fd\u96a8\u6642\u66f4\u65b0\uff0c\u5efa\u8b70\u8b80\u8005\u4f9d\u64da\u6700\u65b0\u5b98\u65b9\u516c\u544a\u6216\u8aee\u8a62\u5c08\u696d\u9867\u554f\u5f8c\u518d\u884c\u6c7a\u7b56\u3002\u5982\u9700\u8f49\u8f09\uff0c\u8acb\u8a3b\u660e\u51fa\u8655\u4e26\u53d6\u5f97\u6388\u6b0a\u3002<\/p>\n<\/blockquote>\n<p>    <\/main><br \/>\n  <\/article>","protected":false},"excerpt":{"rendered":"<p>\u7f8e\u570b\u5316\u599d\u54c1 MoCRA \u548c\u53f0\u7063\u5316\u599d\u54c1\u6cd5\u898f\u5dee\u7570 ds &middot; 2026-06-25 ALT: \u7f8e\u570bMo [&hellip;]<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"footnotes":""},"categories":[1],"tags":[],"class_list":["post-20507","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/posts\/20507"}],"collection":[{"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/comments?post=20507"}],"version-history":[{"count":0,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/posts\/20507\/revisions"}],"wp:attachment":[{"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/media?parent=20507"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/categories?post=20507"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/tags?post=20507"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}