{"id":20461,"date":"2026-06-18T14:25:10","date_gmt":"2026-06-18T06:25:10","guid":{"rendered":"https:\/\/greenoo.tw\/fda-%e5%8c%96%e5%a6%9d%e5%93%81%e4%b8%8d%e7%ad%89%e5%90%8c%e4%b8%8a%e5%b8%82%e5%af%a9%e6%89%b9%ef%bc%81%e4%b8%80%e6%ac%a1%e7%9c%8b%e6%87%82%e4%b8%80%e8%88%ac%e7%be%8e%e5%a6%9d%e8%88%87-otc-%e8%97%a5\/"},"modified":"2026-06-18T14:25:10","modified_gmt":"2026-06-18T06:25:10","slug":"fda-%e5%8c%96%e5%a6%9d%e5%93%81%e4%b8%8d%e7%ad%89%e5%90%8c%e4%b8%8a%e5%b8%82%e5%af%a9%e6%89%b9%ef%bc%81%e4%b8%80%e6%ac%a1%e7%9c%8b%e6%87%82%e4%b8%80%e8%88%ac%e7%be%8e%e5%a6%9d%e8%88%87-otc-%e8%97%a5","status":"publish","type":"post","link":"https:\/\/greenoo.tw\/en\/fda-%e5%8c%96%e5%a6%9d%e5%93%81%e4%b8%8d%e7%ad%89%e5%90%8c%e4%b8%8a%e5%b8%82%e5%af%a9%e6%89%b9%ef%bc%81%e4%b8%80%e6%ac%a1%e7%9c%8b%e6%87%82%e4%b8%80%e8%88%ac%e7%be%8e%e5%a6%9d%e8%88%87-otc-%e8%97%a5\/","title":{"rendered":"FDA \u5316\u599d\u54c1\u4e0d\u7b49\u540c\u4e0a\u5e02\u5be9\u6279\uff01\u4e00\u6b21\u770b\u61c2\u4e00\u822c\u7f8e\u599d\u8207 OTC \u85e5\u599d\u76e3\u7ba1\u5dee\u7570"},"content":{"rendered":"<article class=\"wp-container\">\n<header class=\"wp-header\">\n<h1>FDA \u5316\u599d\u54c1\u4e0d\u7b49\u540c\u4e0a\u5e02\u5be9\u6279\uff01\u4e00\u6b21\u770b\u61c2\u4e00\u822c\u7f8e\u599d\u8207 OTC \u85e5\u599d\u76e3\u7ba1\u5dee\u7570<\/h1>\n<div class=\"meta\">ds &middot; 2026-06-18<\/div>\n<\/header>\n<p>    <main class=\"wp-content\"><\/p>\n<p><img decoding=\"async\" alt=\"FDA \u5316\u599d\u54c1\u76e3\u7ba1\u8207 OTC \u85e5\u599d\u5408\u898f\u5dee\u7570\u5b8c\u6574\u6307\u5357\" src=\"https:\/\/seo-resouce.easyya.ai\/ai-generated-pro\/20260618\/fda-cosmetics-otc-drug-compliance-difference-taiwan-sellers.png?v=None\"><br \/>\n<strong>ALT:<\/strong> FDA \u5316\u599d\u54c1\u4e0a\u5e02\u4e0d\u9700\u5be9\u6279\uff0c\u4f46 OTC \u85e5\u599d\u9700\u7b26\u5408\u56b4\u683c\u76e3\u7ba1\u8981\u6c42\uff0c\u53f0\u7063\u8ce3\u5bb6\u5fc5\u77e5\u5408\u898f\u5dee\u7570<\/p>\n<h2 id=\"fda\">\u7f8e\u599d\u8ce3\u5bb6\u5fc5\u8b80\uff1aFDA \u5316\u599d\u54c1\u4e0d\u7b49\u540c\u4e0a\u5e02\u5be9\u6279\uff0c\u4f60\u7684\u7522\u54c1\u5c6c\u65bc\u54ea\u4e00\u985e\uff1f<\/h2>\n<blockquote>\n<p><strong>Key Conclusion<\/strong>\uff1a\u8a31\u591a\u53f0\u7063\u96fb\u5546\u8ce3\u5bb6\u8aa4\u4ee5\u70ba\u9032\u5165\u7f8e\u570b\u5e02\u5834\u7684\u5316\u599d\u54c1\u9700\u8981\u901a\u904e FDA \u5be9\u6279\u624d\u80fd\u4e0a\u67b6\uff0c\u4e8b\u5be6\u4e0a\u4e00\u822c<strong>\u5316\u599d\u54c1\uff08Cosmetics\uff09\u5728\u7f8e\u570b\u4e26\u4e0d\u9700\u8981\u4e0a\u5e02\u524d\u5be9\u67e5<\/strong>\uff0c\u4f46\u300c\u85e5\u599d\u54c1\uff08OTC Drug\uff09\u300d\u5247\u53d7\u5230\u622a\u7136\u4e0d\u540c\u7684\u76e3\u7ba1\u6846\u67b6\u7d04\u675f\u3002\u641e\u6e05\u695a\u9019\u5169\u8005\u7684\u5dee\u7570\uff0c\u4e0d\u50c5\u80fd\u907f\u514d\u932f\u8aa4\u5408\u898f\u7b56\u7565\uff0c\u66f4\u80fd\u8b93\u4f60\u7684\u54c1\u724c\u5728\u4e9e\u99ac\u905c\u7f8e\u570b\u7ad9\u5b89\u5168\u3001\u5408\u6cd5\u5730\u9577\u671f\u7d93\u71df\u3002<\/p>\n<\/blockquote>\n<p>\u5c0d\u65bc\u60f3\u8981\u9032\u8ecd\u7f8e\u570b\u5e02\u5834\u7684\u53f0\u7063\u7f8e\u599d\u54c1\u724c\u4f86\u8aaa\uff0c\u300cFDA \u5408\u898f\u300d\u9019\u56db\u500b\u5b57\u65e2\u719f\u6089\u53c8\u4ee4\u4eba\u56f0\u60d1\u3002\u5f88\u591a\u8ce3\u5bb6\u6703\u554f\uff1a\u6211\u7684\u4fdd\u6fd5\u4e73\u6db2\u8981\u901a\u904e FDA \u5be9\u6838\u55ce\uff1f\u9632\u66ec\u4e73\u5462\uff1f\u542b\u6709\u7f8e\u767d\u6210\u5206\u7684\u7522\u54c1\u5462\uff1f<\/p>\n<p>\u95dc\u9375\u5728\u65bc\uff1a<strong>FDA \u5c0d\u4e0d\u540c\u985e\u578b\u7684\u7f8e\u599d\u8207\u500b\u4eba\u8b77\u7406\u7522\u54c1\uff0c\u6709\u8457\u5b8c\u5168\u4e0d\u540c\u7684\u76e3\u7ba1\u898f\u5247<\/strong>\u3002\u82e5\u5c07\u5316\u599d\u54c1\u8aa4\u6b78\u985e\u70ba\u4e00\u822c\u6d88\u8cbb\u54c1\u3001\u6216\u5c07\u5177\u85e5\u6548\u8072\u7a31\u7684\u7522\u54c1\u6309\u5316\u599d\u54c1\u6cd5\u898f\u8655\u7406\uff0c\u90fd\u53ef\u80fd\u9762\u81e8\u4e9e\u99ac\u905c\u4e0b\u67b6\u3001\u6d77\u95dc\u67e5\u6263\uff0c\u751a\u81f3 FDA \u8b66\u544a\u4fe1\u7b49\u98a8\u96aa\u3002<\/p>\n<p>\u672c\u6587\u5c07\u5f9e\u6cd5\u898f\u57fa\u790e\u51fa\u767c\uff0c\u6e05\u695a\u62c6\u89e3\u300c\u4e00\u822c\u5316\u599d\u54c1\u300d\u8207\u300cOTC \u85e5\u599d\u54c1\u300d\u7684\u76e3\u7ba1\u5dee\u7570\uff0c\u4e26\u63d0\u4f9b\u53f0\u7063\u8ce3\u5bb6\u5be6\u969b\u53ef\u64cd\u4f5c\u7684\u5408\u898f\u65b9\u5411\u3002<\/p>\n<hr>\n<h2 id=\"_1\">\u672c\u6587\u9069\u7528\u5c0d\u8c61\u8207\u60c5\u5883<\/h2>\n<p>\u2705 <strong>Applicable Scenarios<\/strong>::<\/p>\n<ul>\n<li>\u8a08\u756b\u5728\u4e9e\u99ac\u905c\u7f8e\u570b\u7ad9\u92b7\u552e\u8b77\u819a\u3001\u5f69\u599d\u3001\u8b77\u9aee\u6216\u500b\u4eba\u8b77\u7406\u7522\u54c1\u7684\u53f0\u7063\u8ce3\u5bb6<\/li>\n<li>\u7522\u54c1\u542b\u6709\u9632\u66ec\u4fc2\u6578\uff08SPF\uff09\u3001\u6297\u75d8\u6210\u5206\uff08\u5982\u6c34\u694a\u9178\u3001\u82ef\u7532\u91af\u904e\u6c27\u5316\u7269\uff09\u6216\u6b62\u6c57\u6210\u5206\u7b49\u7279\u6b8a\u529f\u6548\u8072\u7a31<\/li>\n<li>\u5df2\u6709\u7f8e\u599d\u7522\u54c1\u4f46\u4e0d\u78ba\u5b9a\u662f\u5426\u7b26\u5408\u7f8e\u570b FDA \u6cd5\u898f\uff0c\u9700\u8981\u91cd\u65b0\u8a55\u4f30\u5408\u898f\u98a8\u96aa\u7684\u54c1\u724c\u4e3b<\/li>\n<\/ul>\n<p>\u274c <strong>Not Applicable\/Cautions<\/strong>::<\/p>\n<ul>\n<li>\u672c\u6587\u4e0d\u9069\u7528\u65bc\u91ab\u7642\u5668\u6750\uff08Medical Device\uff09\u6216\u8655\u65b9\u85e5\uff08Prescription Drug\uff09\u7684\u5408\u898f\u898f\u5283<\/li>\n<li>\u82e5\u7522\u54c1\u540c\u6642\u6d89\u53ca\u591a\u500b\u5e02\u5834\uff08\u5982\u6b50\u76df CPNP \u6216\u65e5\u672c\u539a\u751f\u52de\u52d5\u7701\uff09\uff0c\u5408\u898f\u8981\u6c42\u9700\u53e6\u884c\u8a55\u4f30\uff0c\u4e0d\u53ef\u76f4\u63a5\u5957\u7528\u7f8e\u570b\u898f\u5247<\/li>\n<\/ul>\n<hr>\n<h2 id=\"fda_1\">\u70ba\u4ec0\u9ebc\u53f0\u7063\u8ce3\u5bb6\u5e38\u8aa4\u89e3 FDA \u5316\u599d\u54c1\u6cd5\u898f\uff1f<\/h2>\n<p>\u7f8e\u570b FDA\uff08\u98df\u54c1\u85e5\u7269\u7ba1\u7406\u5c40\uff09\u5c0d\u5316\u599d\u54c1\u7684\u76e3\u7ba1\u9577\u671f\u88ab\u5916\u754c\u8aa4\u89e3\uff0c\u4e3b\u8981\u539f\u56e0\u6709\u5169\u500b\uff1a<\/p>\n<p><strong>\u7b2c\u4e00\uff0cFDA \u7684\u76e3\u7ba1\u7bc4\u570d\u6975\u5ee3<\/strong>\uff0c\u5f9e\u98df\u54c1\u3001\u85e5\u54c1\u5230\u91ab\u7642\u5668\u6750\u3001\u5316\u599d\u54c1\u90fd\u5728\u5176\u7ba1\u8f44\u4e4b\u4e0b\uff0c\u8b93\u4eba\u76f4\u89ba\u8a8d\u70ba\u6240\u6709\u7522\u54c1\u90fd\u9700\u8981\u300cFDA \u6838\u51c6\u300d\u3002<\/p>\n<p><strong>\u7b2c\u4e8c\uff0c2022 \u5e74\u7f8e\u570b\u300a\u5316\u599d\u54c1\u76e3\u7ba1\u73fe\u4ee3\u5316\u6cd5\u300b\uff08MoCRA, Modernization of Cosmetics Regulation Act\uff09<\/strong>\u6b63\u5f0f\u751f\u6548\uff0c\u5927\u5e45\u66f4\u65b0\u4e86\u5c0d\u5316\u599d\u54c1\u696d\u8005\u7684\u6cd5\u898f\u8981\u6c42\uff0c\u5305\u62ec\u8a2d\u65bd\u767b\u8a18\u3001\u7522\u54c1\u5217\u518a\uff08Product Listing\uff09\u3001\u56b4\u91cd\u4e0d\u826f\u4e8b\u4ef6\u901a\u5831\u7b49\u7fa9\u52d9\uff0c\u8b93\u6574\u500b\u5408\u898f\u74b0\u5883\u8b8a\u5f97\u66f4\u52a0\u8907\u96dc\u3002<\/p>\n<p>\u7136\u800c\uff0c\u5373\u4fbf\u5728 MoCRA \u5be6\u65bd\u5f8c\uff0c<strong>\u4e00\u822c\u5316\u599d\u54c1\u4f9d\u7136\u4e0d\u9700\u8981\u4e0a\u5e02\u524d\u5be9\u6279\uff08Premarket Approval\uff09<\/strong>\u3002FDA \u7684\u89d2\u8272\u66f4\u50cf\u662f\u300c\u5e02\u5834\u5f8c\u76e3\u7ba1\u300d\uff0c\u7531\u696d\u8005\u81ea\u884c\u78ba\u4fdd\u7522\u54c1\u5b89\u5168\uff0cFDA \u5247\u5728\u767c\u73fe\u554f\u984c\u6642\u4ecb\u5165\u57f7\u6cd5\u3002<\/p>\n<p>\u9019\u8207\u53f0\u7063\u6216\u6b50\u76df\uff08EU Cosmetics Regulation\uff09\u7684\u67d0\u4e9b\u5f37\u5236\u9001\u6aa2\u6a5f\u5236\u4e0d\u540c\uff0c\u9020\u6210\u8a31\u591a\u8ce3\u5bb6\u8aa4\u5224\u9580\u6abb\u9ad8\u4f4e\u3002<\/p>\n<p><strong>\u771f\u6b63\u9700\u8981\u4e0a\u5e02\u524d\u5be9\u6279\u7684\uff0c\u662f\u88ab\u6b78\u985e\u70ba OTC \u85e5\u54c1\uff08Over-the-Counter Drug\uff09\u7684\u7522\u54c1<\/strong>\u2014\u2014\u800c\u9019\u689d\u5206\u754c\u7dda\uff0c\u6b63\u662f\u53f0\u7063\u8ce3\u5bb6\u6700\u9700\u8981\u641e\u61c2\u7684\u6838\u5fc3\u77e5\u8b58\u3002<\/p>\n<hr>\n<h2 id=\"vs-otc\">\u4e00\u822c\u5316\u599d\u54c1 vs. OTC \u85e5\u599d\uff1a\u6838\u5fc3\u76e3\u7ba1\u5dee\u7570\u5168\u89e3\u6790<\/h2>\n<h3 id=\"_2\">\u4e09\u6b65\u9a5f\u5feb\u901f\u5224\u65b7\u4f60\u7684\u7522\u54c1\u5c6c\u65bc\u54ea\u4e00\u985e<\/h3>\n<p><strong>Step 1\uff1a\u78ba\u8a8d\u7522\u54c1\u7684\u529f\u6548\u8072\u7a31\uff08Claim\uff09<\/strong><\/p>\n<p>\u5224\u65b7\u4e00\u500b\u7522\u54c1\u662f\u300c\u5316\u599d\u54c1\u300d\u9084\u662f\u300cOTC \u85e5\u54c1\u300d\uff0c<strong>\u6700\u95dc\u9375\u7684\u4f9d\u64da\u662f\u7522\u54c1\u7684\u529f\u6548\u8072\u7a31\uff0c\u800c\u4e0d\u662f\u6210\u5206\u672c\u8eab<\/strong>\u3002FDA \u7684\u5b9a\u7fa9\u5982\u4e0b\uff1a<\/p>\n<ul>\n<li><strong>Cosmetic<\/strong>\uff1a\u4ee5\u6e05\u6f54\u3001\u7f8e\u5316\u3001\u4fc3\u9032\u5438\u5f15\u529b\u6216\u6539\u8b8a\u5916\u89c0\u70ba\u76ee\u7684\uff0c\u4e0d\u5f71\u97ff\u8eab\u9ad4\u7d50\u69cb\u6216\u529f\u80fd<\/li>\n<li><strong>OTC \u85e5\u54c1<\/strong>\uff1a\u8072\u7a31\u80fd\u6cbb\u7642\u3001\u9810\u9632\u6216\u6539\u5584\u7279\u5b9a\u8eab\u9ad4\u72c0\u6cc1\uff0c\u5f71\u97ff\u8eab\u9ad4\u7d50\u69cb\u6216\u529f\u80fd<\/li>\n<\/ul>\n<p>\u8209\u4f8b\uff1a\u4e00\u74f6\u4e73\u6db2\u82e5\u53ea\u6a19\u699c\u300c\u6ecb\u6f64\u808c\u819a\u3001\u63d0\u5347\u5149\u6fa4\u300d\u2192 \u5316\u599d\u54c1\u3002\u82e5\u6a19\u699c\u300c\u542b SPF 30 \u9632\u66ec\u3001\u9810\u9632\u65e5\u66ec\u66ec\u50b7\u300d\u2192 OTC \u85e5\u54c1\u3002<\/p>\n<p>\u9019\u500b\u6b65\u9a5f\u901a\u5e38\u9700\u8981\u4ed4\u7d30\u5be9\u95b1\u7522\u54c1\u6a19\u7c64\u3001\u4e9e\u99ac\u905c listing \u6587\u6848\u53ca\u884c\u92b7\u7d20\u6750\uff0c\u5efa\u8b70\u82b1\u4e00\u81f3\u5169\u5468\u6642\u9593\u5168\u9762\u76e4\u9ede\u3002<\/p>\n<p><strong>Step 2\uff1a\u5c0d\u7167 FDA \u8a8d\u53ef\u7684 OTC \u6d3b\u6027\u6210\u5206\u6e05\u55ae<\/strong><\/p>\n<p>\u82e5\u4f60\u7684\u7522\u54c1\u542b\u6709\u4ee5\u4e0b\u5e38\u898b\u6210\u5206\u4e26\u9644\u5e36\u76f8\u95dc\u8072\u7a31\uff0c\u6975\u53ef\u80fd\u88ab\u6b78\u985e\u70ba OTC \u85e5\u54c1\uff1a<\/p>\n<ul>\n<li><strong>\u9632\u66ec\u5291<\/strong>\uff08Sunscreen Actives\uff09\uff1a\u5982 Avobenzone\u3001Homosalate\u3001Zinc Oxide \u7b49<\/li>\n<li><strong>\u6297\u75d8\u6210\u5206<\/strong>\uff08Acne Treatment\uff09\uff1a\u5982\u82ef\u7532\u91af\u904e\u6c27\u5316\u7269\uff08Benzoyl Peroxide\uff09\u3001\u6c34\u694a\u9178\uff08Salicylic Acid\uff09<\/li>\n<li><strong>\u6b62\u6c57\u5291<\/strong>\uff08Antiperspirant\uff09\uff1a\u5982\u6c2f\u5316\u92c1\uff08Aluminum Chlorohydrate\uff09<\/li>\n<li><strong>\u53bb\u5c51\u6210\u5206<\/strong>\uff08Antidandruff\uff09\uff1a\u5982\u5421\u5576\u786b\u916e\u92c5\uff08Zinc Pyrithione\uff09<\/li>\n<\/ul>\n<p>FDA \u91dd\u5c0d\u6bcf\u985e OTC \u6d3b\u6027\u6210\u5206\u90fd\u6709\u5c0d\u61c9\u7684\u300cOTC Monograph\u300d\uff08\u975e\u8655\u65b9\u85e5\u5c08\u8ad6\uff09\uff0c\u898f\u5b9a\u5141\u8a31\u4f7f\u7528\u7684\u6210\u5206\u3001\u6fc3\u5ea6\u4e0a\u9650\u8207\u6a19\u793a\u8981\u6c42\uff0c\u9019\u500b\u6b65\u9a5f\u53ef\u80fd\u9700\u8981\u8aee\u8a62\u5c08\u696d\u5408\u898f\u9867\u554f\u5354\u52a9\u78ba\u8a8d\u3002<\/p>\n<p><strong>Step 3\uff1a\u6839\u64da\u5206\u985e\uff0c\u898f\u5283\u5c0d\u61c9\u7684\u5408\u898f\u8def\u5f91<\/strong><\/p>\n<p>\u78ba\u8a8d\u5206\u985e\u5f8c\uff0c\u4f60\u9700\u8981\u8d70\u4e0d\u540c\u7684\u5408\u898f\u8ecc\u9053\uff1a<\/p>\n<ul>\n<li><strong>\u4e00\u822c\u5316\u599d\u54c1\u8def\u5f91<\/strong>\uff1a\u4f9d MoCRA \u5b8c\u6210\u8a2d\u65bd\u767b\u8a18\uff08Facility Registration\uff09\u8207\u7522\u54c1\u5217\u518a\uff08Product Listing\uff09\uff0c\u78ba\u4fdd\u6a19\u7c64\u7b26\u5408 FD&amp;C Act \u8981\u6c42\uff0c\u7dad\u8b77\u5b8c\u5584\u7684\u7522\u54c1\u5b89\u5168\u6587\u4ef6<\/li>\n<li><strong>OTC \u85e5\u54c1\u8def\u5f91<\/strong>\uff1a\u4f9d\u7167\u5c0d\u61c9 Monograph \u8981\u6c42\u914d\u65b9\u8207\u6a19\u793a\uff1b\u82e5 Monograph \u672a\u6db5\u84cb\uff0c\u5247\u9700\u5411 FDA \u7533\u8acb\u65b0\u85e5\u7533\u8acb\uff08NDA\uff09\u6216 OTC Monograph \u4fee\u8a02\uff0c\u9580\u6abb\u8207\u6210\u672c\u986f\u8457\u63d0\u9ad8<\/li>\n<\/ul>\n<h3 id=\"vs-otc-vs\">\u4e00\u822c\u5316\u599d\u54c1 vs. OTC \u85e5\u599d vs. \u96d9\u91cd\u8eab\u4efd\u7522\u54c1\u76e3\u7ba1\u6bd4\u8f03<\/h3>\n<p>\u4e86\u89e3\u5206\u985e\u5f8c\uff0c\u4ee5\u4e0b\u6bd4\u8f03\u8868\u53ef\u5e6b\u52a9\u4f60\u5feb\u901f\u638c\u63e1\u4e09\u7a2e\u60c5\u5883\u7684\u76e3\u7ba1\u5dee\u7570\uff1a<\/p>\n<table>\n<thead>\n<tr>\n<th>\u6bd4\u8f03\u7dad\u5ea6<\/th>\n<th>\u4e00\u822c\u5316\u599d\u54c1\uff08Cosmetic\uff09<\/th>\n<th>OTC \u85e5\u599d\u54c1\uff08OTC Drug\uff09<\/th>\n<th>\u96d9\u91cd\u8eab\u4efd\u7522\u54c1\uff08Both\uff09<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>\u4e0a\u5e02\u524d FDA \u5be9\u6279<\/td>\n<td>unnecessary<\/td>\n<td>\u9700\u7b26\u5408 OTC Monograph \u6216 NDA<\/td>\n<td>\u85e5\u54c1\u90e8\u5206\u9700\u7b26\u5408\u898f\u5b9a<\/td>\n<\/tr>\n<tr>\n<td>\u8a2d\u65bd\u767b\u8a18\uff08MoCRA\uff09<\/td>\n<td>\u9700\u8981\uff082023 \u5e74\u8d77\uff09<\/td>\n<td>\u9700\u540c\u6642\u7b26\u5408\u85e5\u54c1\u767b\u8a18\u898f\u5b9a<\/td>\n<td>\u96d9\u91cd\u767b\u8a18\u7fa9\u52d9<\/td>\n<\/tr>\n<tr>\n<td>\u7522\u54c1\u5217\u518a\uff08MoCRA\uff09<\/td>\n<td>need<\/td>\n<td>\u9700\u85e5\u54c1 NDC \u767b\u8a18<\/td>\n<td>\u96d9\u91cd\u5217\u518a<\/td>\n<\/tr>\n<tr>\n<td>\u6a19\u7c64\u8981\u6c42<\/td>\n<td>FD&amp;C Act \u5316\u599d\u54c1\u898f\u5b9a<\/td>\n<td>OTC Drug Facts \u6a19\u7c64\u683c\u5f0f<\/td>\n<td>\u9808\u540c\u6642\u7b26\u5408\u5169\u5957\u898f\u5b9a<\/td>\n<\/tr>\n<tr>\n<td>\u914d\u65b9\u9650\u5236<\/td>\n<td>\u7981\u7528\u6210\u5206\u6e05\u55ae\uff08\u8f03\u77ed\uff09<\/td>\n<td>\u6d3b\u6027\u6210\u5206\u9808\u5728 Monograph \u7bc4\u570d\u5167<\/td>\n<td>\u4ee5\u85e5\u54c1\u898f\u5b9a\u70ba\u512a\u5148<\/td>\n<\/tr>\n<tr>\n<td>Adverse Event Notification<\/td>\n<td>\u56b4\u91cd\u4e8b\u4ef6\u5f37\u5236\u901a\u5831<\/td>\n<td>\u5f37\u5236\u901a\u5831\uff08\u66f4\u56b4\u683c\uff09<\/td>\n<td>\u4f9d\u85e5\u54c1\u898f\u5b9a<\/td>\n<\/tr>\n<tr>\n<td>Risk of non-compliance<\/td>\n<td>\u8b66\u544a\u4fe1\u3001\u53ec\u56de<\/td>\n<td>\u8b66\u544a\u4fe1\u3001\u5e02\u5834\u7981\u5165\u3001\u5211\u4e8b\u8cac\u4efb<\/td>\n<td>\u540c OTC \u85e5\u54c1<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h3 id=\"mocra\">MoCRA \u65b0\u6cd5\u5c0d\u53f0\u7063\u5316\u599d\u54c1\u8ce3\u5bb6\u7684\u5be6\u8cea\u5f71\u97ff<\/h3>\n<p>2022 \u5e74\u5e95\u901a\u904e\u7684\u300a\u5316\u599d\u54c1\u76e3\u7ba1\u73fe\u4ee3\u5316\u6cd5\u300b\uff08MoCRA\uff09\u662f\u7f8e\u570b\u8fd1 80 \u5e74\u4f86\u6700\u91cd\u5927\u7684\u5316\u599d\u54c1\u6cd5\u898f\u6539\u9769\uff0c\u53f0\u7063\u8ce3\u5bb6\u4e0d\u53ef\u8f15\u5ffd\u5176\u5f71\u97ff\u3002<\/p>\n<p><strong>Facility Registration<\/strong><\/p>\n<p>\u4efb\u4f55\u5728\u7f8e\u570b\u5883\u5167\u88fd\u9020\u3001\u52a0\u5de5\u6216\u5305\u88dd\u5316\u599d\u54c1\u7684\u8a2d\u65bd\uff0c\u6216\u51fa\u53e3\u81f3\u7f8e\u570b\u7684\u5883\u5916\u88fd\u9020\u5546\uff0c\u90fd\u9700\u8981\u5728 FDA \u5b8c\u6210\u8a2d\u65bd\u767b\u8a18\uff0c\u4e26\u6bcf\u5169\u5e74\u66f4\u65b0\u4e00\u6b21\u3002\u5c0d\u53f0\u7063 OEM\/ODM \u5de5\u5ee0\u8207\u54c1\u724c\u5546\u800c\u8a00\uff0c<strong>\u91d0\u6e05\u8ab0\u662f\u300c\u8cac\u4efb\u65b9\u300d\uff08Responsible Person\uff09<\/strong>\u3001\u8ab0\u9700\u8981\u767b\u8a18\uff0c\u662f\u7b2c\u4e00\u500b\u5fc5\u9808\u89e3\u6c7a\u7684\u554f\u984c\u3002<\/p>\n<p><strong>\u7522\u54c1\u5217\u518a\uff08Product Listing\uff09<\/strong><\/p>\n<p>\u6bcf\u6b3e\u5728\u7f8e\u570b\u5e02\u5834\u92b7\u552e\u7684\u5316\u599d\u54c1\uff0c\u8cac\u4efb\u65b9\u9808\u5411 FDA \u63d0\u4ea4\u7522\u54c1\u5217\u518a\uff0c\u5167\u5bb9\u5305\u62ec\u7522\u54c1\u540d\u7a31\u3001\u985e\u5225\u3001\u6210\u5206\u6e05\u55ae\uff08\u4ee5 INCI \u540d\u7a31\u7533\u5831\uff09\u53ca\u6240\u6709\u6a19\u7c64\u8cc7\u8a0a\u3002\u9019\u4e0d\u662f\u4e00\u6b21\u6027\u4f5c\u696d\uff0c\u6bcf\u7576\u7522\u54c1\u6709\u91cd\u5927\u8b8a\u66f4\uff08\u5982\u66f4\u63db\u914d\u65b9\uff09\u90fd\u9700\u8981\u66f4\u65b0\u3002<\/p>\n<p><strong>\u56b4\u91cd\u4e0d\u826f\u4e8b\u4ef6\u901a\u5831\uff08Serious Adverse Event Reporting\uff09<\/strong><\/p>\n<p>\u82e5\u6d88\u8cbb\u8005\u56e0\u4f7f\u7528\u4f60\u7684\u5316\u599d\u54c1\u767c\u751f\u9700\u8981\u4f4f\u9662\u3001\u7dca\u6025\u5c31\u91ab\u3001\u6c38\u4e45\u6027\u50b7\u5bb3\u7b49\u56b4\u91cd\u4e8b\u4ef6\uff0c\u8cac\u4efb\u65b9\u5fc5\u9808\u5728\u7279\u5b9a\u671f\u9650\u5167\u5411 FDA \u901a\u5831\u3002\u9019\u9805\u8981\u6c42\u4f7f\u54c1\u724c\u4e3b\u9700\u8981\u5efa\u7acb\u6b63\u5f0f\u7684\u6d88\u8cbb\u8005\u6295\u8a34\u8ffd\u8e64\u6a5f\u5236\u3002<\/p>\n<p><strong>\u7522\u54c1\u5b89\u5168\u6587\u4ef6\uff08Safety Substantiation\uff09<\/strong><\/p>\n<p>MoCRA \u660e\u78ba\u8981\u6c42\u5316\u599d\u54c1\u4e0a\u5e02\u524d\u5fc5\u9808\u6709\u5145\u5206\u7684\u5b89\u5168\u6027\u4f50\u8b49\u6587\u4ef6\u3002\u96d6\u7136\u4e0d\u9700\u8981\u63d0\u4ea4\u7d66 FDA \u5be9\u6838\uff0c\u4f46\u4e00\u65e6\u767c\u751f\u6d88\u8cbb\u8005\u7cfe\u7d1b\u6216 FDA \u7a3d\u67e5\uff0c\u54c1\u724c\u5fc5\u9808\u80fd\u63d0\u4f9b\u5b8c\u6574\u7684\u5b89\u5168\u8a55\u4f30\u5831\u544a\u3002<\/p>\n<h3 id=\"otc-monograph\">OTC \u85e5\u599d\u54c1\u7684\u5408\u898f\u6df1\u5751\uff1aMonograph \u9ad4\u7cfb\u8a73\u89e3<\/h3>\n<p>\u5c0d\u65bc\u542b\u6709\u9632\u66ec\u3001\u6297\u75d8\u7b49\u6210\u5206\u7684\u7522\u54c1\uff0cOTC Monograph \u9ad4\u7cfb\u662f\u53f0\u7063\u8ce3\u5bb6\u6700\u9700\u8981\u6df1\u5165\u7406\u89e3\u7684\u6a5f\u5236\u3002<\/p>\n<p><strong>\u4ec0\u9ebc\u662f OTC Monograph\uff1f<\/strong><\/p>\n<p>OTC Monograph \u662f FDA \u91dd\u5c0d\u7279\u5b9a\u985e\u5225\u975e\u8655\u65b9\u85e5\u5236\u5b9a\u7684\u300c\u4e00\u822c\u6027\u8a31\u53ef\u898f\u7bc4\u300d\uff0c\u53ea\u8981\u7522\u54c1\u7684\u6d3b\u6027\u6210\u5206\u7a2e\u985e\u3001\u6fc3\u5ea6\u3001\u9069\u61c9\u75c7\u8072\u7a31\u53ca\u6a19\u793a\u683c\u5f0f\u90fd\u7b26\u5408\u5c0d\u61c9 Monograph \u7684\u898f\u5b9a\uff0c\u5ee0\u5546<strong>\u4e0d\u9700\u8981\u500b\u5225\u7533\u8acb\u85e5\u54c1\u6838\u51c6<\/strong>\u5373\u53ef\u5408\u6cd5\u4e0a\u5e02\u3002<\/p>\n<p>\u9019\u500b\u6a5f\u5236\u807d\u8d77\u4f86\u53cb\u5584\uff0c\u4f46\u5be6\u969b\u57f7\u884c\u4e2d\u5b58\u5728\u4e0d\u5c11\u9677\u9631\uff1a<\/p>\n<p><strong>\u9677\u9631\u4e00\uff1a\u9632\u66ec\u4fc2\u6578\u8072\u7a31\u89f8\u767c\u85e5\u54c1\u5206\u985e<\/strong><\/p>\n<p>\u8a31\u591a\u53f0\u7063\u8ce3\u5bb6\u5728\u7522\u54c1\u63cf\u8ff0\u4e2d\u52a0\u5165\u300cSPF\u300d\u6578\u503c\uff0c\u537b\u4e0d\u77e5\u9053\u9019\u4e00\u500b\u8072\u7a31\u5c31\u8b93\u7522\u54c1\u5f9e\u5316\u599d\u54c1\u8b8a\u6210\u4e86 OTC \u85e5\u54c1\u3002\u4e00\u65e6\u6210\u70ba OTC \u85e5\u54c1\uff0c\u7522\u54c1\u5fc5\u9808\u4f7f\u7528\u300cDrug Facts\u300d\u6a19\u7c64\u683c\u5f0f\uff0c\u6e05\u695a\u5217\u51fa\u6d3b\u6027\u6210\u5206\u3001\u7528\u9014\u3001\u8b66\u544a\u3001\u4f7f\u7528\u65b9\u6cd5\u53ca\u5176\u4ed6\u6210\u5206\u3002\u82e5\u4e9e\u99ac\u905c listing \u6216\u5916\u5305\u88dd\u672a\u7b26\u5408\u9019\u500b\u683c\u5f0f\uff0c\u96a8\u6642\u9762\u81e8\u4e0b\u67b6\u98a8\u96aa\u3002<\/p>\n<p><strong>\u9677\u9631\u4e8c\uff1a\u300c\u7f8e\u767d\u300d\u6210\u5206\u7684\u7070\u8272\u5730\u5e36<\/strong><\/p>\n<p>\u542b\u6709\u6c2b\u918c\uff08Hydroquinone\uff09\u7684\u7f8e\u767d\u7522\u54c1\u5728\u7f8e\u570b\u66fe\u6709 OTC Monograph \u4f9d\u64da\uff0c\u4f46 FDA \u8fd1\u5e74\u5df2\u53d6\u6d88\u5c0d OTC \u6c2b\u918c\u7522\u54c1\u7684\u4e00\u822c\u6027\u8a8d\u53ef\uff0c\u76ee\u524d\u6c2b\u918c\u7f8e\u767d\u7522\u54c1\u5728\u7f8e\u570b\u9700\u8981\u8655\u65b9\u624d\u80fd\u5408\u6cd5\u92b7\u552e\u3002\u53f0\u7063\u8a31\u591a\u4ee5\u300c\u7f8e\u767d\u300d\u70ba\u4e3b\u6253\u7684\u4fdd\u990a\u54c1\uff0c\u82e5\u542b\u6709\u6b64\u6210\u5206\uff0c\u5728\u7f8e\u570b\u5e02\u5834\u5c07\u9762\u81e8\u56b4\u91cd\u5408\u898f\u554f\u984c\u3002<\/p>\n<p><strong>\u9677\u9631\u4e09\uff1a\u6b62\u6c57\u5291 vs. \u9664\u81ed\u5291\u7684\u5dee\u7570<\/strong><\/p>\n<p>\u6b62\u6c57\u5291\uff08Antiperspirant\uff09\u56e0\u542b\u6709\u5f71\u97ff\u6c57\u817a\u5206\u6ccc\u7684\u6d3b\u6027\u6210\u5206\uff0c\u88ab\u6b78\u985e\u70ba OTC \u85e5\u54c1\uff1b\u9664\u81ed\u5291\uff08Deodorant\uff09\u82e5\u53ea\u662f\u6291\u5236\u6c23\u5473\u800c\u975e\u6c57\u6db2\u5206\u6ccc\uff0c\u5247\u5c6c\u65bc\u5316\u599d\u54c1\u3002\u8a31\u591a\u540c\u6642\u6a19\u699c\u300c\u6b62\u6c57\uff0b\u9664\u81ed\u300d\u7684\u7522\u54c1\uff0c\u5be6\u969b\u4e0a\u5c6c\u65bc\u96d9\u91cd\u8eab\u4efd\uff0c\u9700\u540c\u6642\u7b26\u5408\u5169\u5957\u898f\u5b9a\u3002<\/p>\n<p><img decoding=\"async\" alt=\"FDA OTC Monograph \u9ad4\u7cfb\u8aaa\u660e\u8207\u53f0\u7063\u7f8e\u599d\u54c1\u724c\u5408\u898f\u8def\u5f91\u793a\u610f\u5716\" src=\"https:\/\/seo-resouce.easyya.ai\/ai-generated-pro\/20260618\/fda-otc-monograph-sunscreen-acne-antiperspirant-taiwan-amazon-compliance.png?v=None\"><br \/>\n<strong>ALT:<\/strong> FDA OTC Monograph \u898f\u7bc4\u9632\u66ec\u6297\u75d8\u6b62\u6c57\u7b49\u85e5\u599d\u6210\u5206\uff0c\u53f0\u7063\u96fb\u5546\u8ce3\u5bb6\u9700\u4e86\u89e3\u5316\u599d\u54c1\u8207 OTC \u85e5\u54c1\u5206\u985e\u5dee\u7570\u4ee5\u78ba\u4fdd\u4e9e\u99ac\u905c\u5408\u898f\u4e0a\u67b6<\/p>\n<hr>\n<h2 id=\"_3\">\u9032\u968e\u88dc\u5145\uff1a\u5bb9\u6613\u6df7\u6dc6\u7684\u908a\u754c\u6848\u4f8b\u8207\u5e38\u898b\u8aa4\u89e3<\/h2>\n<h3 id=\"_4\">\u7279\u6b8a\u60c5\u5883\u8655\u7406<\/h3>\n<p><strong>\u60c5\u5883\u4e00\uff1a\u7cbe\u6cb9\u8207\u5929\u7136\u6210\u5206\u7522\u54c1<\/strong><\/p>\n<p>\u8a31\u591a\u53f0\u7063\u54c1\u724c\u4e3b\u6253\u300c\u5929\u7136\u300d\u3001\u300c\u8349\u672c\u300d\u914d\u65b9\uff0c\u8a8d\u70ba\u9019\u985e\u7522\u54c1\u4e0d\u9700\u8981\u64d4\u5fc3 FDA \u5408\u898f\u3002\u7136\u800c\uff0c<strong>\u82e5\u5929\u7136\u6210\u5206\u642d\u914d\u4e86\u85e5\u6548\u8072\u7a31<\/strong>\uff08\u5982\u300c\u85b0\u8863\u8349\u7cbe\u6cb9\u5e6b\u52a9\u8212\u7de9\u808c\u8089\u75e0\u75db\u300d\uff09\uff0c\u7522\u54c1\u4f9d\u7136\u53ef\u80fd\u88ab\u6b78\u985e\u70ba\u85e5\u54c1\u3002FDA \u7684\u5224\u65b7\u4f9d\u64da\u662f\u8072\u7a31\u7684\u6027\u8cea\uff0c\u800c\u975e\u6210\u5206\u662f\u5426\u5929\u7136\u3002<\/p>\n<p><strong>\u60c5\u5883\u4e8c\uff1a\u5b30\u5e7c\u5152\u5316\u599d\u54c1<\/strong><\/p>\n<p>\u91dd\u5c0d\u5b30\u5e7c\u5152\u7684\u8b77\u819a\u7522\u54c1\u5728\u5b89\u5168\u6a19\u6e96\u4e0a\u53d7\u5230\u66f4\u56b4\u683c\u7684\u793e\u6703\u671f\u5f85\uff0c\u96d6\u7136\u6cd5\u898f\u6846\u67b6\u76f8\u540c\uff0c\u4f46 FDA \u5c0d\u6b64\u985e\u7522\u54c1\u7684\u4e0d\u826f\u4e8b\u4ef6\u5c24\u70ba\u654f\u611f\u3002\u82e5\u542b\u6709\u4efb\u4f55\u985e\u4f3c OTC \u6d3b\u6027\u6210\u5206\u7684\u8072\u7a31\uff0c\u98a8\u96aa\u66f4\u9ad8\u3002<\/p>\n<p><strong>\u60c5\u5883\u4e09\uff1a\u9032\u53e3\u5546\u8207\u54c1\u724c\u5546\u7684\u8cac\u4efb\u5283\u5206<\/strong><\/p>\n<p>MoCRA \u5f15\u5165\u4e86\u300c\u8cac\u4efb\u65b9\uff08Responsible Person\uff09\u300d\u6982\u5ff5\uff1a\u5728\u7f8e\u570b\u5883\u5167\uff0c\u6a19\u7c64\u4e0a\u6a19\u793a\u7684\u88fd\u9020\u5546\u6216\u5206\u92b7\u5546\u5373\u70ba\u8cac\u4efb\u65b9\uff0c\u9700\u627f\u64d4\u8a2d\u65bd\u767b\u8a18\u3001\u7522\u54c1\u5217\u518a\u53ca\u4e0d\u826f\u4e8b\u4ef6\u901a\u5831\u7684\u6cd5\u5f8b\u8cac\u4efb\u3002\u53f0\u7063\u8ce3\u5bb6\u900f\u904e\u4e9e\u99ac\u905c FBA \u92b7\u552e\u6642\uff0c\u82e5\u7522\u54c1\u6a19\u7c64\u4e0a\u53ea\u6709\u53f0\u7063\u88fd\u9020\u5546\u8cc7\u8a0a\u800c\u7121\u7f8e\u570b\u8cac\u4efb\u65b9\uff0c\u53ef\u80fd\u9762\u81e8\u5408\u898f\u7f3a\u53e3\u3002<\/p>\n<h3 id=\"_5\">\u5e38\u898b\u8aa4\u89e3\u6f84\u6e05<\/h3>\n<p><strong>\u8aa4\u89e3\u4e00\uff1a\u300c\u901a\u904e\u53f0\u7063\u885b\u798f\u90e8\u5be9\u6838\uff0c\u7f8e\u570b\u5c31\u6c92\u554f\u984c\u300d<\/strong><\/p>\n<p>\u53f0\u7063\u8207\u7f8e\u570b\u7684\u5316\u599d\u54c1\u76e3\u7ba1\u9ad4\u7cfb\u5b8c\u5168\u7368\u7acb\uff0c\u53f0\u7063\u7684\u5316\u599d\u54c1\u8a31\u53ef\u6587\u4ef6\u5c0d FDA \u4e0d\u5177\u4efb\u4f55\u6548\u529b\u3002\u5c24\u5176\u662f OTC \u85e5\u54c1\u985e\u5225\uff0c\u5169\u5730\u7684\u5206\u985e\u6a19\u6e96\u4e5f\u4e0d\u76f8\u540c\u3002<\/p>\n<p><strong>\u8aa4\u89e3\u4e8c\uff1a\u300c\u5728\u4e9e\u99ac\u905c\u4e0a\u67b6\u6210\u529f\u4ee3\u8868\u5408\u898f\u300d<\/strong><\/p>\n<p>\u4e9e\u99ac\u905c\u5e73\u53f0\u7684\u4e0a\u67b6\u5be9\u6838\u4e26\u4e0d\u7b49\u540c\u65bc FDA \u5408\u898f\u8a8d\u53ef\u3002\u4e9e\u99ac\u905c\u53ef\u80fd\u5728\u5f8c\u7e8c\u7a3d\u6838\u4e2d\u8981\u6c42\u63d0\u4ea4\u5408\u898f\u6587\u4ef6\uff0c\u6216\u56e0\u6d88\u8cbb\u8005\u6295\u8a34\u89f8\u767c\u5be9\u67e5\u3002<strong>\u4e0a\u67b6\u6210\u529f\u53ea\u662f\u8d77\u9ede\uff0c\u6301\u7e8c\u7dad\u8b77\u5408\u898f\u624d\u662f\u9577\u671f\u5728\u7f8e\u570b\u5e02\u5834\u751f\u5b58\u7684\u95dc\u9375\u3002<\/strong><\/p>\n<p><strong>\u8aa4\u89e3\u4e09\uff1a\u300c\u5c0f\u54c1\u724c\u4e0d\u6703\u88ab FDA \u67e5\u5230\u300d<\/strong><\/p>\n<p>MoCRA \u8ce6\u4e88 FDA \u66f4\u5f37\u7684\u57f7\u6cd5\u5de5\u5177\uff0c\u5305\u62ec\u5f37\u5236\u53ec\u56de\uff08Mandatory Recall\uff09\u6b0a\u529b\u3002\u96a8\u8457\u6578\u4f4d\u5316\u8ffd\u8e64\u80fd\u529b\u63d0\u5347\uff0c\u300c\u898f\u6a21\u5c0f\u5c31\u4e0d\u6703\u88ab\u67e5\u300d\u7684\u50e5\u5016\u5fc3\u614b\u98a8\u96aa\u8d8a\u4f86\u8d8a\u9ad8\u3002<\/p>\n<hr>\n<h2 id=\"faq\">Frequently Asked Questions FAQ<\/h2>\n<h3 id=\"q1-fda\">Q1\uff1a\u5982\u4f55\u5224\u65b7\u6211\u7684\u7f8e\u599d\u7522\u54c1\u662f\u5426\u9700\u8981\u5728 FDA \u9032\u884c\u8a2d\u65bd\u767b\u8a18\uff1f<\/h3>\n<p>\u6839\u64da MoCRA \u898f\u5b9a\uff0c\u53ea\u8981\u4f60\u7684\u7522\u54c1\u5728\u7f8e\u570b\u5e02\u5834\u92b7\u552e\uff0c\u4e14\u4f60\u662f\u8a72\u7522\u54c1\u7684\u8cac\u4efb\u65b9\uff08Responsible Person\uff09\u2014\u2014\u901a\u5e38\u662f\u6a19\u7c64\u4e0a\u6a19\u793a\u7684\u88fd\u9020\u5546\u6216\u54c1\u724c\u5546\u2014\u2014\u5c31\u9700\u8981\u5728 FDA \u5b8c\u6210\u8a2d\u65bd\u767b\u8a18\u3002\u53f0\u7063\u8ce3\u5bb6\u900f\u904e\u4e9e\u99ac\u905c\u92b7\u552e\u6642\uff0c\u5efa\u8b70\u5148\u78ba\u8a8d\u81ea\u5df1\u662f\u5426\u7b26\u5408\u300c\u8cac\u4efb\u65b9\u300d\u5b9a\u7fa9\uff0c\u518d\u6c7a\u5b9a\u767b\u8a18\u7fa9\u52d9\u3002\u82e5\u7531\u53f0\u7063\u5de5\u5ee0\u4ee3\u5de5\uff0c\u4e5f\u9700\u78ba\u8a8d\u5de5\u5ee0\u662f\u5426\u5df2\u5b8c\u6210\u5883\u5916\u8a2d\u65bd\u767b\u8a18\u3002<\/p>\n<h3 id=\"q2-spf-otc\">Q2\uff1a\u542b SPF \u7684\u6f64\u8272\u9694\u96e2\u971c\uff0c\u662f\u5316\u599d\u54c1\u9084\u662f OTC \u85e5\u54c1\uff1f<\/h3>\n<p>\u542b\u6709\u9632\u66ec\u4fc2\u6578\uff08SPF\uff09\u8072\u7a31\u7684\u7522\u54c1\uff0c\u7121\u8ad6\u5916\u89c0\u662f\u591a\u9ebc\u300c\u5f69\u599d\u611f\u300d\uff0c\u5728 FDA \u773c\u4e2d\u90fd\u5c6c\u65bc OTC \u85e5\u54c1\u3002\u9019\u985e\u96d9\u91cd\u529f\u80fd\u7522\u54c1\uff08Cosmetic-Drug Combination\uff09\u9700\u8981\u540c\u6642\u7b26\u5408\u5316\u599d\u54c1\u8207 OTC \u85e5\u54c1\u7684\u6a19\u793a\u898f\u5b9a\uff0c\u5305\u62ec\u5fc5\u9808\u5728\u5916\u5305\u88dd\u4e0a\u6a19\u793a\u300cDrug Facts\u300d\u6a19\u7c64\u3002\u4e9e\u99ac\u905c\u7f8e\u570b\u7ad9\u5c0d\u6b64\u985e\u7522\u54c1\u6709\u984d\u5916\u7684\u5408\u898f\u6587\u4ef6\u8981\u6c42\uff0c\u5efa\u8b70\u4e0a\u67b6\u524d\u5148\u8aee\u8a62\u5c08\u696d\u9867\u554f\u78ba\u8a8d\u3002<\/p>\n<h3 id=\"q3otc\">Q3\uff1aOTC \u85e5\u599d\u54c1\u7684\u5408\u898f\u6e96\u5099\u9700\u8981\u591a\u5c11\u6642\u9593\u8207\u6210\u672c\uff1f<\/h3>\n<p>\u6642\u9593\u8207\u6210\u672c\u56e0\u7522\u54c1\u985e\u578b\u800c\u5dee\u7570\u986f\u8457\u3002\u82e5\u7522\u54c1\u7b26\u5408\u73fe\u6709 OTC Monograph\uff08\u5982\u6a19\u6e96\u9632\u66ec\u4fc2\u6578\u7bc4\u570d\u5167\u7684\u9632\u66ec\u4e73\uff09\uff0c\u5408\u898f\u6e96\u5099\u4e3b\u8981\u96c6\u4e2d\u5728\u6a19\u7c64\u8a2d\u8a08\u3001\u6210\u5206\u8abf\u6574\u8207\u6587\u4ef6\u6574\u5099\uff0c\u76f8\u5c0d\u53ef\u63a7\u3002\u82e5\u7522\u54c1\u9700\u8981\u900f\u904e NDA \u7533\u8acb\uff0c\u5247\u6d89\u53ca\u81e8\u5e8a\u8a66\u9a57\u8207\u66f4\u9577\u7684\u5be9\u67e5\u5468\u671f\uff0c\u6210\u672c\u8207\u6642\u9593\u5747\u5927\u5e45\u63d0\u5347\u3002\u5efa\u8b70\u53f0\u7063\u8ce3\u5bb6\u5148\u9032\u884c\u521d\u6b65\u7522\u54c1\u5206\u985e\u8a55\u4f30\uff0c\u518d\u6839\u64da\u7d50\u679c\u898f\u5283\u5408\u898f\u9810\u7b97\uff0c\u53ef\u6d3d\u8a62\u7da0\u5708\u5708 Greenoo \u7684 FDA \u5408\u898f\u9867\u554f\u7372\u53d6\u5ba2\u88fd\u5316\u8a55\u4f30\u3002<\/p>\n<hr>\n<h2 id=\"_6\">Conclusion<\/h2>\n<p>\u641e\u61c2 FDA \u5c0d\u5316\u599d\u54c1\u8207 OTC \u85e5\u599d\u54c1\u7684\u76e3\u7ba1\u5dee\u7570\uff0c\u662f\u53f0\u7063\u7f8e\u599d\u54c1\u724c\u9032\u8ecd\u7f8e\u570b\u5e02\u5834\u7684\u7b2c\u4e00\u9053\u95dc\u5361\u3002\u4ee5\u4e0b\u4e09\u500b\u6838\u5fc3\u91cd\u9ede\u503c\u5f97\u53cd\u8986\u78ba\u8a8d\uff1a<\/p>\n<p><strong>\u7b2c\u4e00\uff0c\u5206\u985e\u6c7a\u5b9a\u5408\u898f\u8def\u5f91\u3002<\/strong> \u5316\u599d\u54c1\u4e0d\u9700\u8981 FDA \u4e0a\u5e02\u524d\u5be9\u6279\uff0c\u4f46 OTC \u85e5\u54c1\u5fc5\u9808\u7b26\u5408 OTC Monograph \u6216 NDA \u8981\u6c42\u3002\u529f\u6548\u8072\u7a31\u662f\u5224\u65b7\u5206\u985e\u7684\u6838\u5fc3\u4f9d\u64da\uff0c\u4efb\u4f55\u9632\u66ec\u3001\u6b62\u6c57\u3001\u6297\u75d8\u7b49\u8072\u7a31\u90fd\u53ef\u80fd\u89f8\u767c OTC \u85e5\u54c1\u5206\u985e\u3002<\/p>\n<p><strong>\u7b2c\u4e8c\uff0cMoCRA \u5df2\u5168\u9762\u6539\u8b8a\u5316\u599d\u54c1\u5408\u898f\u7fa9\u52d9\u3002<\/strong> \u5373\u4f7f\u662f\u300c\u4e00\u822c\u5316\u599d\u54c1\u300d\uff0c\u5728 MoCRA \u5be6\u65bd\u5f8c\u4e5f\u9700\u5b8c\u6210\u8a2d\u65bd\u767b\u8a18\u3001\u7522\u54c1\u5217\u518a\u4e26\u5efa\u7acb\u5b89\u5168\u6587\u4ef6\uff0c\u9019\u662f\u9032\u5165\u7f8e\u570b\u5e02\u5834\u7684\u6700\u4f4e\u9580\u6abb\uff0c\u4e0d\u53ef\u5ffd\u8996\u3002<\/p>\n<p><strong>\u7b2c\u4e09\uff0c\u4e9e\u99ac\u905c\u4e0a\u67b6\u4e0d\u7b49\u65bc FDA \u5408\u898f\u3002<\/strong> \u5efa\u7acb\u6301\u7e8c\u6027\u7684\u5408\u898f\u7ba1\u7406\u6a5f\u5236\u3001\u6b63\u78ba\u7684\u7522\u54c1\u6a19\u7c64\u8a2d\u8a08\u8207\u5b8c\u6574\u7684\u5b89\u5168\u4f50\u8b49\u6587\u4ef6\uff0c\u624d\u662f\u5728\u7f8e\u570b\u5e02\u5834\u9577\u671f\u7a69\u5065\u7d93\u71df\u7684\u4fdd\u969c\u3002<\/p>\n<p>\u5c0d\u65bc\u6b63\u5728\u898f\u5283\u7f8e\u570b\u5e02\u5834\u4f48\u5c40\u7684\u53f0\u7063\u54c1\u724c\u4f86\u8aaa\uff0c\u53ca\u65e9\u9032\u884c\u7522\u54c1\u5408\u898f\u8a55\u4f30\uff0c\u6bd4\u4e8b\u5f8c\u88dc\u6551\u4ed8\u51fa\u7684\u4ee3\u50f9\u8981\u5c0f\u5f97\u591a\u3002<\/p>\n<p>\u5982\u679c\u60a8\u6b63\u5728\u898f\u5283\u54c1\u724c\u51fa\u6d77\uff0c\u6216\u5c0d VAT\u3001EPR\u3001FDA \u7b49\u5408\u898f\u8981\u6c42\u611f\u5230\u56f0\u60d1\uff0c\u6b61\u8fce\u9020\u8a2a <strong>\u7da0\u5708\u5708 Greenoo<\/strong>\uff08<a href=\"https:\/\/greenoo.tw\/en\/\">https:\/\/greenoo.tw\/<\/a>\uff09\uff0c\u7531\u5c08\u696d\u7684\u8de8\u5883\u96fb\u5546\u5408\u898f\u9867\u554f\u5718\u968a\u70ba\u60a8\u63d0\u4f9b\u4e00\u7ad9\u5f0f\u89e3\u6c7a\u65b9\u6848\u3002\u7acb\u5373\u8aee\u8a62\uff0c\u8b93\u5408\u898f\u4e0d\u518d\u662f\u51fa\u6d77\u7684\u969c\u7919\uff0c\u800c\u662f\u60a8\u54c1\u724c\u5728\u570b\u969b\u5e02\u5834\u812b\u7a4e\u800c\u51fa\u7684\u7af6\u722d\u512a\u52e2\uff01<\/p>\n<hr>\n<h2 id=\"_7\">\u53c3\u8003\u8cc7\u6599<\/h2>\n<ol>\n<li>U.S. Food &amp; Drug Administration. &#8220;Cosmetics Overview: FDA&#8217;s Authority Over Cosmetics&#8221;.<br \/>\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-laws-regulations\/fdas-authority-over-cosmetics-how-cosmetics-are-not-fda-approved-are-fda-regulated\" rel=\"nofollow\">https:\/\/www.fda.gov\/cosmetics\/cosmetics-laws-regulations\/fdas-authority-over-cosmetics-how-cosmetics-are-not-fda-approved-are-fda-regulated<\/a><\/li>\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\">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;OTC Drug Monograph System&#8221;.<br \/>\n<a href=\"https:\/\/www.fda.gov\/drugs\/over-counter-otc-drug-monograph-system\" rel=\"nofollow\">https:\/\/www.fda.gov\/drugs\/over-counter-otc-drug-monograph-system<\/a><\/li>\n<li>U.S. Food &amp; Drug Administration. &#8220;Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)&#8221;.<br \/>\n<a href=\"https:\/\/www.fda.gov\/cosmetics\/cosmetics-laws-regulations\/it-cosmetic-drug-or-both-or-it-soap\" rel=\"nofollow\">https:\/\/www.fda.gov\/cosmetics\/cosmetics-laws-regulations\/it-cosmetic-drug-or-both-or-it-soap<\/a><\/li>\n<li>U.S. Food &amp; Drug Administration. &#8220;Sunscreen: How to Help Protect Your Skin from the Sun&#8221;.<br \/>\n<a href=\"https:\/\/www.fda.gov\/drugs\/understanding-over-counter-medicines\/sunscreen-how-help-protect-your-skin-sun\" rel=\"nofollow\">https:\/\/www.fda.gov\/drugs\/understanding-over-counter-medicines\/sunscreen-how-help-protect-your-skin-sun<\/a><\/li>\n<\/ol>\n<p><em>Note: Standards may be updated, please check the latest official documents or consult professional advisors.<\/em><\/p>\n<hr>\n<p><strong>\u95dc\u65bc \u7da0\u5708\u5708 Greenoo<\/strong><\/p>\n<p>\u7da0\u5708\u5708\uff08Greenoo\uff09\u662f\u53f0\u7063\u5c08\u696d\u7684\u4e9e\u99ac\u905c\u8de8\u5883\u96fb\u5546\u5408\u898f\u670d\u52d9\u5e73\u53f0\uff0c\u7531\u4f86\u81ea\u7f8e\u570b\u3001\u65e5\u672c\u3001\u6b50\u76df\u53ca\u4e2d\u570b\u7684\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\u52a9\u529b\u53f0\u7063\u8ce3\u5bb6\u54c1\u724c\u6210\u529f\u51fa\u6d77\u3002\u5b98\u65b9\u7db2\u7ad9\uff1a<a href=\"https:\/\/greenoo.tw\/en\/\">https:\/\/greenoo.tw\/<\/a><\/p>\n<blockquote>\n<p><strong>Disclaimer<\/strong>\uff1a\u672c\u6587\u5167\u5bb9\u7531\u7da0\u5708\u5708 Greenoo \u5167\u5bb9\u5718\u968a\u64b0\u5beb\uff0c\u50c5\u4f9b\u4e00\u822c\u8cc7\u8a0a\u53c3\u8003\u4e4b\u7528\uff0c\u4e0d\u69cb\u6210\u4efb\u4f55\u6cd5\u5f8b\u3001\u7a05\u52d9\u6216\u5408\u898f\u5c08\u696d\u5efa\u8b70\u3002\u76f8\u95dc\u6cd5\u898f\u53ef\u80fd\u96a8\u6642\u66f4\u65b0\uff0c\u5efa\u8b70\u8b80\u8005\u4f9d\u64da\u81ea\u8eab\u5be6\u969b\u60c5\u6cc1\u8aee\u8a62\u5c08\u696d\u9867\u554f\u3002\u672c\u6587\u7248\u6b0a\u6b78\u7da0\u5708\u5708 Greenoo \u6240\u6709\uff0c\u672a\u7d93\u6388\u6b0a\u8acb\u52ff\u8f49\u8f09\u3002<\/p>\n<\/blockquote>\n<p>    <\/main><br \/>\n  <\/article>","protected":false},"excerpt":{"rendered":"<p>FDA \u5316\u599d\u54c1\u4e0d\u7b49\u540c\u4e0a\u5e02\u5be9\u6279\uff01\u4e00\u6b21\u770b\u61c2\u4e00\u822c\u7f8e\u599d\u8207 OTC \u85e5\u599d\u76e3\u7ba1\u5dee\u7570 ds &middot; 2026-06 [&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-20461","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/posts\/20461"}],"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=20461"}],"version-history":[{"count":0,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/posts\/20461\/revisions"}],"wp:attachment":[{"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/media?parent=20461"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/categories?post=20461"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/greenoo.tw\/en\/wp-json\/wp\/v2\/tags?post=20461"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}