{"id":8093,"date":"2024-05-29T11:42:04","date_gmt":"2024-05-29T03:42:04","guid":{"rendered":"https:\/\/greenoo.tw\/?p=8093"},"modified":"2026-01-27T08:54:29","modified_gmt":"2026-01-27T00:54:29","slug":"fda-approved-chinese-herbal-medicine-compliance-guide-2026","status":"publish","type":"post","link":"https:\/\/greenoo.tw\/zh\/fda-approved-chinese-herbal-medicine-compliance-guide-2026\/","title":{"rendered":"\u3010\u7da0\u5708\u5708\u8aaa\u8de8\u5883\u3011\u7f8e\u570bFDA\u552f\u4e00\u5165\u7684\u4e2d\u85e5\u6750\u662f\u4ec0\u9ebd"},"content":{"rendered":"<h2><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone size-full wp-image-20033\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-chinese-herbal-medicine-compliance-truth-feature-2026.png\" alt=\"\u7f8e\u570b FDA \u4e2d\u85e5\u6750\u76e3\u7ba1\u771f\u76f8\u5c01\u9762,\u986f\u793a\u4e2d\u85e5\u6750\u5716\u793a\u8207\u98df\u54c1\u85e5\u54c1\u5206\u985e\u8aaa\u660e,\u6f84\u6e05\u5e38\u898b\u8a8d\u53ef\u8aa4\u89e3 \" width=\"2560\" height=\"1352\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-chinese-herbal-medicine-compliance-truth-feature-2026.png 2560w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-chinese-herbal-medicine-compliance-truth-feature-2026-768x406.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-chinese-herbal-medicine-compliance-truth-feature-2026-1536x811.png 1536w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-chinese-herbal-medicine-compliance-truth-feature-2026-2048x1082.png 2048w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-chinese-herbal-medicine-compliance-truth-feature-2026-18x10.png 18w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/><\/h2>\n<h2>\u76f4\u63a5\u56de\u7b54:FDA \u6c92\u6709\u300c\u552f\u4e00\u8a8d\u53ef\u300d\u7684\u4e2d\u85e5\u6750<\/h2>\n<p><strong>\u7b54\u6848\u662f:\u7f8e\u570b FDA \u4e26\u6c92\u6709\u300c\u552f\u4e00\u8a8d\u53ef\u300d\u7684\u4e2d\u85e5\u6750\u3002<\/strong> \u9019\u662f\u4e00\u500b\u5e38\u898b\u7684\u8aa4\u89e3\u3002\u6839\u64da <a href=\"https:\/\/www.fda.gov\/food\/dietary-supplements\" target=\"_blank\" rel=\"noopener\">FDA \u5b98\u65b9\u98df\u54c1\u8207\u85e5\u54c1\u5b9a\u7fa9<\/a>\u4e2d\u85e5\u6750\u5728\u7f8e\u570b\u5e02\u5834\u7684\u5408\u6cd5\u6027\u53d6\u6c7a\u65bc\u5176<strong>\u7522\u54c1\u5b9a\u4f4d<\/strong>\u8207<strong>\u7528\u9014\u8072\u7a31<\/strong>,\u800c\u975e\u7279\u5b9a\u54c1\u9805\u7684\u300c\u8a8d\u53ef\u6e05\u55ae\u300d\u3002<\/p>\n<p>\u5177\u9ad4\u4f86\u8aaa:<\/p>\n<ul>\n<li><strong>\u4f5c\u70ba\u98df\u54c1\u6216\u81b3\u98df\u88dc\u5145\u5291\u8ca9\u552e<\/strong>:\u9700\u7b26\u5408 <a href=\"https:\/\/www.fda.gov\/food\/food-safety-modernization-act-fsma\" target=\"_blank\" rel=\"noopener\">FDA \u98df\u54c1\u5b89\u5168\u6cd5\u898f<\/a>\u8207\u81b3\u98df\u88dc\u5145\u5291\u6a19\u7c64\u8981\u6c42,\u7121\u9700\u4e0a\u5e02\u524d\u6279\u51c6<\/li>\n<li><strong>\u4f5c\u70ba\u85e5\u54c1\u8ca9\u552e<\/strong>:\u5fc5\u9808\u7d93\u904e FDA \u65b0\u85e5\u5be9\u67e5(NDA)\u6216\u7c21\u5316\u65b0\u85e5\u7533\u8acb(ANDA),\u53d6\u5f97\u85e5\u54c1\u8a31\u53ef<\/li>\n<li><strong>GRAS \u7269\u8cea<\/strong>:\u82e5\u4e2d\u85e5\u6750\u6210\u5206\u88ab\u5217\u5165 <a href=\"https:\/\/www.fda.gov\/food\/generally-recognized-safe-gras\" target=\"_blank\" rel=\"noopener\">FDA GRAS \u8cc7\u6599\u5eab<\/a>(Generally Recognized as Safe),\u53ef\u4f5c\u70ba\u98df\u54c1\u6dfb\u52a0\u7269\u4f7f\u7528<\/li>\n<\/ul>\n<p>\u53f0\u7063\u696d\u8005\u5e38\u8aa4\u4ee5\u70ba\u67d0\u4e9b\u4e2d\u85e5\u6750\u300c\u7372\u5f97 FDA \u8a8d\u53ef\u300d,\u5be6\u969b\u4e0a\u662f\u56e0\u70ba\u9019\u4e9b\u6210\u5206\u7b26\u5408 GRAS \u6a19\u6e96,\u6216\u4ee5\u81b3\u98df\u88dc\u5145\u5291\u5f62\u5f0f\u5408\u6cd5\u8ca9\u552e,\u800c\u975e\u901a\u904e\u85e5\u54c1\u5be9\u67e5\u3002<\/p>\n<hr \/>\n<h2>\u70ba\u4f55\u6703\u7522\u751f\u300cFDA \u552f\u4e00\u8a8d\u53ef\u4e2d\u85e5\u6750\u300d\u7684\u8aa4\u89e3?<\/h2>\n<p>\u9019\u500b\u8aa4\u89e3\u4e3b\u8981\u6e90\u65bc\u4e09\u500b\u539f\u56e0:<\/p>\n<p><strong>1. \u6df7\u6dc6\u98df\u54c1\u8207\u85e5\u54c1\u7684\u76e3\u7ba1\u908f\u8f2f<\/strong><br \/>\nFDA \u5c0d\u98df\u54c1\u63a1\u53d6\u300c\u4e8b\u5f8c\u76e3\u7ba1\u300d(\u4e0a\u5e02\u5f8c\u62bd\u67e5),\u5c0d\u85e5\u54c1\u63a1\u53d6\u300c\u4e8b\u524d\u5be9\u67e5\u300d(\u4e0a\u5e02\u524d\u6279\u51c6)\u3002\u8a31\u591a\u53f0\u7063\u696d\u8005\u5c07\u300c\u53ef\u5408\u6cd5\u8ca9\u552e\u300d\u8aa4\u89e3\u70ba\u300c\u7372\u5f97\u8a8d\u53ef\u300d,\u5be6\u969b\u4e0a\u5169\u8005\u6cd5\u898f\u908f\u8f2f\u5b8c\u5168\u4e0d\u540c\u3002<\/p>\n<p><strong>2. \u81b3\u98df\u88dc\u5145\u5291\u7684\u7070\u8272\u5730\u5e36<\/strong><br \/>\n\u4f9d\u64da <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/section-101.93\" target=\"_blank\" rel=\"noopener\">CFR Title 21 \u00a7 101.93<\/a>,\u81b3\u98df\u88dc\u5145\u5291\u53ef\u5728\u6a19\u7c64\u4e0a\u8072\u7a31\u300c\u7d50\u69cb\/\u529f\u80fd\u5ba3\u7a31\u300d(\u5982\u300c\u652f\u6301\u514d\u75ab\u7cfb\u7d71\u300d),\u4f46\u4e0d\u5f97\u8072\u7a31\u300c\u75be\u75c5\u6cbb\u7642\u300d\u3002\u9019\u8b93\u90e8\u5206\u4e2d\u85e5\u6750\u4ee5\u81b3\u98df\u88dc\u5145\u5291\u5f62\u5f0f\u9032\u5165\u5e02\u5834,\u4f46\u4e26\u975e\u300c\u85e5\u54c1\u8a8d\u53ef\u300d\u3002<\/p>\n<p><strong>3. GRAS \u7269\u8cea\u7684\u8aa4\u8b80<\/strong><br \/>\n\u90e8\u5206\u4e2d\u85e5\u6750\u6210\u5206(\u5982\u8591\u9ec3\u7d20\u3001\u4eba\u53c3\u8403\u53d6\u7269)\u88ab\u5217\u5165 GRAS \u6e05\u55ae,\u4ee3\u8868\u300c\u5728\u7279\u5b9a\u7528\u91cf\u4e0b\u88ab\u666e\u904d\u8a8d\u70ba\u5b89\u5168\u300d,\u4f46\u9019\u4e0d\u7b49\u65bc FDA\u300c\u63a8\u85a6\u300d\u6216\u300c\u8a8d\u53ef\u300d\u5176\u7642\u6548\u3002<\/p>\n<p>\u82e5\u5c1a\u672a\u5efa\u7acb\u5c0d FDA \u98df\u54c1\u8a3b\u518a\u5236\u5ea6\u7684\u6574\u9ad4\u7406\u89e3,\u5efa\u8b70\u5148\u5f9e\u5b8c\u6574\u7e3d\u89bd\u5165\u624b,\u6709\u52a9\u65bc\u5f8c\u7e8c\u5224\u65b7\u4e0d\u540c\u60c5\u5883\u8207\u57f7\u884c\u5dee\u7570\u3002<\/p>\n<p>\ud83d\udc49 <strong>FDA \u98df\u54c1\u8a3b\u518a\u5b8c\u6574\u6307\u5357|\u53f0\u7063\u98df\u54c1\u51fa\u53e3\u7f8e\u570b\u5fc5\u8b80(2026 \u6700\u65b0)<\/strong><br \/>\n<a href=\"https:\/\/greenoo.tw\/zh\/fda-food-registration\/\" target=\"_blank\" rel=\"noopener\">https:\/\/greenoo.tw\/fda-food-registration\/<\/a><\/p>\n<hr \/>\n<h2>\u4e2d\u85e5\u6750\u5728\u7f8e\u570b\u7684\u4e09\u7a2e\u5408\u898f\u8def\u5f91<\/h2>\n<h3>\u8def\u5f91\u4e00:\u4f5c\u70ba\u98df\u54c1\u6216\u9999\u6599\u4f7f\u7528<\/h3>\n<p><strong>\u9069\u7528\u60c5\u5883<\/strong>:<br \/>\n\u4e2d\u85e5\u6750\u50c5\u4f5c\u70ba\u98df\u54c1\u539f\u6599(\u5982\u8591\u3001\u7d05\u68d7\u3001\u67b8\u675e)\u6216\u9999\u6599\u4f7f\u7528,\u4e0d\u505a\u4efb\u4f55\u5065\u5eb7\u5ba3\u7a31\u3002<\/p>\n<p><strong>\u5408\u898f\u8981\u6c42<\/strong>:<\/p>\n<ul>\n<li>\u7b26\u5408 FDA \u98df\u54c1\u5b89\u5168\u6a19\u6e96(\u7121\u8fb2\u85e5\u6b98\u7559\u3001\u91cd\u91d1\u5c6c\u8d85\u6a19\u7b49)<\/li>\n<li>\u5b8c\u6210 <a href=\"https:\/\/www.fda.gov\/food\/food-facility-registration\" target=\"_blank\" rel=\"noopener\">FDA \u98df\u54c1\u8a2d\u65bd\u8a3b\u518a<\/a><\/li>\n<li>\u6a19\u7c64\u7b26\u5408 CFR Title 21 Part 101 \u898f\u7bc4<\/li>\n<li>\u82e5\u70ba\u9032\u53e3\u7522\u54c1,\u9032\u53e3\u5546\u9700\u5efa\u7acb FSVP(\u5916\u570b\u4f9b\u61c9\u5546\u9a57\u8b49\u8a08\u756b)<\/li>\n<\/ul>\n<p><strong>\u5e38\u898b\u54c1\u9805<\/strong>:<br \/>\n\u8591\u3001\u5927\u849c\u3001\u7d05\u68d7\u3001\u6842\u5713\u3001\u67b8\u675e\u3001\u5c71\u85e5\u7b49<\/p>\n<hr \/>\n<h3>\u8def\u5f91\u4e8c:\u4f5c\u70ba\u81b3\u98df\u88dc\u5145\u5291(Dietary Supplement)<\/h3>\n<p><strong>\u9069\u7528\u60c5\u5883<\/strong>:<br \/>\n\u4e2d\u85e5\u6750\u4ee5\u81a0\u56ca\u3001\u7c89\u672b\u3001\u9320\u5291\u7b49\u5f62\u5f0f\u8ca9\u552e,\u8072\u7a31\u300c\u652f\u6301\u5065\u5eb7\u300d\u4f46\u4e0d\u8072\u7a31\u6cbb\u7642\u75be\u75c5\u3002<\/p>\n<p><strong>\u5408\u898f\u8981\u6c42<\/strong>:<\/p>\n<ul>\n<li>\u7b26\u5408 <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-B\/part-111\" target=\"_blank\" rel=\"noopener\">CFR Title 21 \u00a7 111<\/a>\u81b3\u98df\u88dc\u5145\u5291 GMP \u898f\u7bc4<\/li>\n<li>\u4e0a\u5e02\u524d 75 \u5929\u5411 FDA \u63d0\u4ea4\u300c\u65b0\u81b3\u98df\u6210\u5206\u901a\u77e5\u300d(NDI Notification,\u82e5\u542b\u65b0\u6210\u5206)<\/li>\n<li>\u6a19\u7c64\u5fc5\u9808\u6a19\u793a\u300c\u672c\u7522\u54c1\u672a\u7d93 FDA \u8a55\u4f30,\u4e0d\u7528\u65bc\u8a3a\u65b7\u3001\u6cbb\u7642\u3001\u6cbb\u7652\u6216\u9810\u9632\u4efb\u4f55\u75be\u75c5\u300d<\/li>\n<li>\u5b8c\u6210\u98df\u54c1\u8a2d\u65bd\u8a3b\u518a<\/li>\n<\/ul>\n<p><strong>\u5e38\u898b\u54c1\u9805<\/strong>:<br \/>\n\u4eba\u53c3\u81a0\u56ca\u3001\u9748\u829d\u8403\u53d6\u7269\u3001\u8591\u9ec3\u7d20\u9320\u5291<\/p>\n<p><strong>\u91cd\u8981\u9650\u5236<\/strong>:<br \/>\n\u4e0d\u5f97\u8072\u7a31\u300c\u6cbb\u7642\u7cd6\u5c3f\u75c5\u300d\u300c\u964d\u8840\u58d3\u300d\u7b49\u75be\u75c5\u6cbb\u7642\u6548\u679c,\u5426\u5247\u5c07\u88ab\u8996\u70ba\u300c\u672a\u7d93\u6279\u51c6\u7684\u65b0\u85e5\u300d\u800c\u906d\u6263\u7559\u3002<\/p>\n<hr \/>\n<h3>\u8def\u5f91\u4e09:\u4f5c\u70ba\u85e5\u54c1\u7533\u8acb\u4e0a\u5e02<\/h3>\n<p><strong>\u9069\u7528\u60c5\u5883<\/strong>:<br \/>\n\u4e2d\u85e5\u6750\u8072\u7a31\u5177\u6709\u75be\u75c5\u6cbb\u7642\u6548\u679c,\u9700\u7d93\u904e\u5b8c\u6574\u7684\u85e5\u54c1\u5be9\u67e5\u7a0b\u5e8f\u3002<\/p>\n<p><strong>\u5408\u898f\u8981\u6c42<\/strong>:<\/p>\n<ul>\n<li>\u63d0\u4ea4\u65b0\u85e5\u7533\u8acb(NDA)\u6216\u7c21\u5316\u65b0\u85e5\u7533\u8acb(ANDA)<\/li>\n<li>\u63d0\u4f9b\u81e8\u5e8a\u8a66\u9a57\u6578\u64da\u8b49\u660e\u5b89\u5168\u6027\u8207\u6709\u6548\u6027<\/li>\n<li>\u901a\u904e FDA \u85e5\u54c1\u5be9\u67e5,\u53d6\u5f97\u4e0a\u5e02\u8a31\u53ef<\/li>\n<li>\u7b26\u5408\u85e5\u54c1 GMP \u898f\u7bc4<\/li>\n<\/ul>\n<p><strong>\u5be6\u52d9\u56f0\u96e3<\/strong>:<br \/>\n\u622a\u81f3 2026 \u5e74,\u5e7e\u4e4e\u6c92\u6709\u7d14\u4e2d\u85e5\u6750\u4ee5\u300c\u85e5\u54c1\u300d\u8eab\u5206\u7372\u5f97 FDA \u6279\u51c6,\u4e3b\u8981\u539f\u56e0\u662f\u81e8\u5e8a\u8a66\u9a57\u6210\u672c\u9ad8\u6602,\u4e14\u4e2d\u85e5\u6750\u6210\u5206\u8907\u96dc,\u96e3\u4ee5\u7b26\u5408\u897f\u65b9\u91ab\u5b78\u7684\u55ae\u4e00\u6d3b\u6027\u6210\u5206\u6a19\u6e96\u3002<\/p>\n<hr \/>\n<h3>\u5716 2: \u4e2d\u85e5\u6750\u5728\u7f8e\u570b\u7684\u4e09\u7a2e\u5408\u898f\u8def\u5f91\u6bd4\u8f03\u5716<\/h3>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-20034\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-chinese-herbal-medicine-compliance-pathways-comparison-2026.png\" alt=\"\u4e2d\u85e5\u6750\u5728\u7f8e\u570b\u7684\u4e09\u7a2e\u5408\u898f\u8def\u5f91\u6bd4\u8f03\u5716,\u986f\u793a\u98df\u54c1\u3001\u81b3\u98df\u88dc\u5145\u5291\u8207\u85e5\u54c1\u7684\u9069\u7528\u60c5\u5883\u8207\u6cd5\u898f\u8981\u6c42\u5dee\u7570\" width=\"2560\" height=\"1429\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-chinese-herbal-medicine-compliance-pathways-comparison-2026.png 2560w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-chinese-herbal-medicine-compliance-pathways-comparison-2026-768x429.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-chinese-herbal-medicine-compliance-pathways-comparison-2026-1536x857.png 1536w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-chinese-herbal-medicine-compliance-pathways-comparison-2026-2048x1143.png 2048w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-chinese-herbal-medicine-compliance-pathways-comparison-2026-18x10.png 18w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/><\/p>\n<hr \/>\n<h2>\u53f0\u7063\u696d\u8005\u5e38\u898b\u7684 5 \u500b\u5408\u898f\u8aa4\u5340<\/h2>\n<h3>\u8aa4\u5340 1:\u300c\u4eba\u53c3\u7372\u5f97 FDA \u8a8d\u53ef,\u6240\u4ee5\u53ef\u4ee5\u5ba3\u7a31\u7642\u6548\u300d<\/h3>\n<p>\u274c <strong>\u932f\u8aa4<\/strong>:\u4eba\u53c3\u53ef\u4f5c\u70ba\u81b3\u98df\u88dc\u5145\u5291\u8ca9\u552e,\u4f46\u4e0d\u5f97\u8072\u7a31\u300c\u6cbb\u7642\u75be\u75c5\u300d\u3002\u82e5\u6a19\u7c64\u4e0a\u5beb\u300c\u6cbb\u7642\u7cd6\u5c3f\u75c5\u300d,\u5c07\u88ab\u8996\u70ba\u672a\u7d93\u6279\u51c6\u7684\u65b0\u85e5\u3002<\/p>\n<p>\u2705 <strong>\u6b63\u78ba\u505a\u6cd5<\/strong>:\u50c5\u8072\u7a31\u300c\u652f\u6301\u6d3b\u529b\u300d\u300c\u7dad\u6301\u5065\u5eb7\u300d\u7b49\u7d50\u69cb\/\u529f\u80fd\u5ba3\u7a31,\u4e26\u6a19\u793a\u514d\u8cac\u8072\u660e\u3002<\/p>\n<hr \/>\n<h3>\u8aa4\u5340 2:\u300cGRAS \u6e05\u55ae\u4e0a\u7684\u6210\u5206\u53ef\u4ee5\u7121\u9650\u91cf\u6dfb\u52a0\u300d<\/h3>\n<p>\u274c <strong>\u932f\u8aa4<\/strong>:GRAS \u8a8d\u5b9a\u662f\u300c\u5728\u7279\u5b9a\u7528\u91cf\u4e0b\u5b89\u5168\u300d,\u8d85\u904e\u5b89\u5168\u7528\u91cf\u4ecd\u53ef\u80fd\u9055\u898f\u3002<\/p>\n<p>\u2705 <strong>\u6b63\u78ba\u505a\u6cd5<\/strong>:\u67e5\u95b1 <a href=\"https:\/\/www.fda.gov\/food\/generally-recognized-safe-gras\" target=\"_blank\" rel=\"noopener\">FDA GRAS \u8cc7\u6599\u5eab<\/a>\u78ba\u8a8d\u8a72\u6210\u5206\u7684\u5b89\u5168\u7528\u91cf\u7bc4\u570d\u3002<\/p>\n<hr \/>\n<h3>\u8aa4\u5340 3:\u300c\u4e2d\u85e5\u6750\u662f\u5929\u7136\u7684,\u4e0d\u9700\u8981\u98df\u54c1\u8a2d\u65bd\u8a3b\u518a\u300d<\/h3>\n<p>\u274c <strong>\u932f\u8aa4<\/strong>:\u53ea\u8981\u5728\u7f8e\u570b\u5883\u5167\u88fd\u9020\u3001\u52a0\u5de5\u3001\u5305\u88dd\u6216\u5009\u5132\u98df\u54c1,\u90fd\u5fc5\u9808\u5b8c\u6210 FDA \u8a2d\u65bd\u8a3b\u518a\u3002<\/p>\n<p>\u2705 <strong>\u6b63\u78ba\u505a\u6cd5<\/strong>:\u5373\u4f7f\u662f\u5929\u7136\u8349\u672c\u7522\u54c1,\u4ecd\u9700\u5b8c\u6210\u8a2d\u65bd\u8a3b\u518a\u8207 FSVP(\u82e5\u70ba\u9032\u53e3)\u3002<\/p>\n<hr \/>\n<h3>\u8aa4\u5340 4:\u300c\u81b3\u98df\u88dc\u5145\u5291\u4e0d\u9700\u8981\u4e0a\u5e02\u524d\u5be9\u67e5\u300d<\/h3>\n<p>\u274c <strong>\u932f\u8aa4<\/strong>:\u82e5\u542b\u6709\u300c\u65b0\u81b3\u98df\u6210\u5206\u300d(1994 \u5e74 10 \u6708 15 \u65e5\u5f8c\u9996\u6b21\u7528\u65bc\u81b3\u98df\u88dc\u5145\u5291\u7684\u6210\u5206),\u9700\u5728\u4e0a\u5e02\u524d 75 \u5929\u63d0\u4ea4 NDI \u901a\u77e5\u3002<\/p>\n<p>\u2705 <strong>\u6b63\u78ba\u505a\u6cd5<\/strong>:\u78ba\u8a8d\u6210\u5206\u662f\u5426\u70ba\u65b0\u81b3\u98df\u6210\u5206,\u82e5\u662f\u5247\u9700\u63d0\u4ea4 NDI \u901a\u77e5\u3002<\/p>\n<hr \/>\n<h3>\u8aa4\u5340 5:\u300cAmazon \u4e0a\u67b6\u6210\u529f\u4ee3\u8868\u7b26\u5408 FDA \u898f\u5b9a\u300d<\/h3>\n<p>\u274c <strong>\u932f\u8aa4<\/strong>:Amazon \u5be9\u6838\u6a19\u6e96\u8207 FDA \u6cd5\u898f\u4e0d\u5b8c\u5168\u4e00\u81f4,\u5e73\u53f0\u901a\u904e\u4e0d\u4ee3\u8868 FDA \u5408\u898f\u3002<\/p>\n<p>\u2705 <strong>\u6b63\u78ba\u505a\u6cd5<\/strong>:\u4e3b\u52d5\u78ba\u8a8d\u7522\u54c1\u5206\u985e\u3001\u6a19\u7c64\u8072\u7a31\u662f\u5426\u7b26\u5408 FDA \u898f\u5b9a,\u907f\u514d\u4e8b\u5f8c\u6263\u95dc\u6216\u4e0b\u67b6\u3002<\/p>\n<p>\u82e5\u9032\u4e00\u6b65\u95dc\u5fc3 Amazon \u5e73\u53f0\u5c0d FDA \u98df\u54c1\u8a3b\u518a\u7684\u5be9\u6838\u8981\u6c42,\u53ef\u53c3\u8003\u4ee5\u4e0b\u8aaa\u660e\u9801\u9762,\u4ee5\u91d0\u6e05\u5be6\u52d9\u4e0a\u7684\u5224\u65b7\u91cd\u9ede\u3002<\/p>\n<p>\ud83d\udc49 <strong>Amazon \u70ba\u4f55\u8981\u6c42 FDA \u98df\u54c1\u8a3b\u518a?\u5e73\u53f0\u5be9\u6838\u898f\u5247\u5b8c\u6574\u89e3\u6790(2026)<\/strong><br \/>\n<a href=\"https:\/\/greenoo.tw\/zh\/fda-food-registration-amazon-fda-food-registration-requirements\/\" target=\"_blank\" rel=\"noopener\">https:\/\/greenoo.tw\/fda-food-registration-amazon-fda-food-registration-requirements\/<\/a><\/p>\n<hr \/>\n<h3>\u5716 3: \u53f0\u7063\u696d\u8005\u4e2d\u85e5\u6750\u51fa\u53e3\u7f8e\u570b\u5e38\u898b\u8aa4\u5340\u6aa2\u6838\u8868<\/h3>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-20035\" src=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-chinese-herbal-medicine-export-misconceptions-checklist-2026.png\" alt=\"\u53f0\u7063\u696d\u8005\u4e2d\u85e5\u6750\u51fa\u53e3\u7f8e\u570b\u5e38\u898b\u8aa4\u5340\u6aa2\u6838\u8868,\u5217\u51fa 5 \u500b\u5e38\u898b\u932f\u8aa4\u89c0\u5ff5,\u5305\u542b GRAS \u8a8d\u53ef\u3001\u75be\u75c5\u6cbb\u7642\u5ba3\u7a31\u7b49\" width=\"1792\" height=\"2400\" srcset=\"https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-chinese-herbal-medicine-export-misconceptions-checklist-2026.png 1792w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-chinese-herbal-medicine-export-misconceptions-checklist-2026-768x1029.png 768w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-chinese-herbal-medicine-export-misconceptions-checklist-2026-1147x1536.png 1147w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-chinese-herbal-medicine-export-misconceptions-checklist-2026-1529x2048.png 1529w, https:\/\/greenoo.tw\/wp-content\/uploads\/2024\/05\/fda-chinese-herbal-medicine-export-misconceptions-checklist-2026-9x12.png 9w\" sizes=\"(max-width: 1792px) 100vw, 1792px\" \/><\/p>\n<hr \/>\n<h2>\u5be6\u52d9\u5efa\u8b70:\u53f0\u7063\u696d\u8005\u5982\u4f55\u5224\u65b7\u4e2d\u85e5\u6750\u7684\u5408\u898f\u8def\u5f91?<\/h2>\n<p><strong>\u6b65\u9a5f 1:\u660e\u78ba\u7522\u54c1\u5b9a\u4f4d<\/strong><br \/>\n\u5148\u78ba\u5b9a\u7522\u54c1\u662f\u4f5c\u70ba\u300c\u98df\u54c1\u300d\u300c\u81b3\u98df\u88dc\u5145\u5291\u300d\u9084\u662f\u300c\u85e5\u54c1\u300d\u8ca9\u552e,\u9019\u6c7a\u5b9a\u4e86\u9069\u7528\u7684\u6cd5\u898f\u6846\u67b6\u3002<\/p>\n<p><strong>\u6b65\u9a5f 2:\u6aa2\u67e5\u6210\u5206\u662f\u5426\u70ba GRAS \u7269\u8cea<\/strong><br \/>\n\u67e5\u95b1 FDA GRAS \u8cc7\u6599\u5eab,\u78ba\u8a8d\u4e2d\u85e5\u6750\u6210\u5206\u662f\u5426\u5df2\u88ab\u8a8d\u5b9a\u70ba\u5b89\u5168,\u4ee5\u53ca\u5b89\u5168\u7528\u91cf\u7bc4\u570d\u3002<\/p>\n<p><strong>\u6b65\u9a5f 3:\u8a2d\u8a08\u5408\u898f\u7684\u6a19\u7c64\u8072\u7a31<\/strong><\/p>\n<ul>\n<li>\u98df\u54c1:\u50c5\u63cf\u8ff0\u7522\u54c1\u7279\u6027,\u4e0d\u505a\u4efb\u4f55\u5065\u5eb7\u5ba3\u7a31<\/li>\n<li>\u81b3\u98df\u88dc\u5145\u5291:\u53ef\u505a\u7d50\u69cb\/\u529f\u80fd\u5ba3\u7a31,\u4f46\u9700\u52a0\u4e0a\u514d\u8cac\u8072\u660e<\/li>\n<li>\u85e5\u54c1:\u9700\u7d93\u904e FDA \u5be9\u67e5,\u4e00\u822c\u4e0d\u5efa\u8b70\u53f0\u7063\u4e2d\u5c0f\u4f01\u696d\u63a1\u7528\u6b64\u8def\u5f91<\/li>\n<\/ul>\n<p><strong>\u6b65\u9a5f 4:\u5b8c\u6210\u5fc5\u8981\u7684\u8a3b\u518a\u8207\u901a\u77e5<\/strong><\/p>\n<ul>\n<li>\u6240\u6709\u8def\u5f91\u90fd\u9700\u5b8c\u6210 FDA \u98df\u54c1\u8a2d\u65bd\u8a3b\u518a<\/li>\n<li>\u81b3\u98df\u88dc\u5145\u5291\u82e5\u542b\u65b0\u6210\u5206\u9700\u63d0\u4ea4 NDI \u901a\u77e5<\/li>\n<li>\u9032\u53e3\u7522\u54c1\u9700\u7531\u7f8e\u570b\u9032\u53e3\u5546\u5efa\u7acb FSVP<\/li>\n<\/ul>\n<p><strong>\u6b65\u9a5f 5:\u5efa\u7acb\u98df\u54c1\u5b89\u5168\u8a08\u756b<\/strong><br \/>\n\u4f9d\u64da <a href=\"https:\/\/www.fda.gov\/food\/food-safety-modernization-act-fsma\/fsma-final-rule-preventive-controls-human-food\" target=\"_blank\" rel=\"noopener\">FSMA \u9810\u9632\u6027\u63a7\u5236\u898f\u5247<\/a>,\u88fd\u9020\u5546\u9700\u5efa\u7acb\u66f8\u9762\u98df\u54c1\u5b89\u5168\u8a08\u756b,\u5305\u542b\u5371\u5bb3\u5206\u6790\u8207\u9810\u9632\u6027\u63a7\u5236\u63aa\u65bd\u3002<\/p>\n<p>\u82e5\u9032\u4e00\u6b65\u95dc\u5fc3 FDA \u98df\u54c1\u8a3b\u518a\u7684\u7533\u8acb\u6d41\u7a0b\u8207\u6240\u9700\u6587\u4ef6,\u53ef\u53c3\u8003\u4ee5\u4e0b\u8aaa\u660e\u9801\u9762,\u4ee5\u91d0\u6e05\u5be6\u52d9\u4e0a\u7684\u5224\u65b7\u91cd\u9ede\u3002<\/p>\n<p>\ud83d\udc49 <strong>FDA \u98df\u54c1\u8a3b\u518a\u6d41\u7a0b\u8207\u6587\u4ef6\u5b8c\u6574\u8aaa\u660e|\u53f0\u7063\u7533\u8acb\u91cd\u9ede\u6574\u7406(2026)<\/strong><br \/>\n<a href=\"https:\/\/greenoo.tw\/zh\/fda-food-registration-fda-food-registration-process-and-documents-taiwan\/\" target=\"_blank\" rel=\"noopener\">https:\/\/greenoo.tw\/fda-food-registration-fda-food-registration-process-and-documents-taiwan\/<\/a><\/p>\n<hr \/>\n<h2>\u7e3d\u7d50<\/h2>\n<ul>\n<li><strong>FDA \u6c92\u6709\u300c\u552f\u4e00\u8a8d\u53ef\u300d\u7684\u4e2d\u85e5\u6750<\/strong>,\u5408\u6cd5\u6027\u53d6\u6c7a\u65bc\u7522\u54c1\u5b9a\u4f4d\u8207\u7528\u9014\u8072\u7a31<\/li>\n<li><strong>\u4e09\u7a2e\u5408\u898f\u8def\u5f91<\/strong>:\u98df\u54c1\/\u9999\u6599\u3001\u81b3\u98df\u88dc\u5145\u5291\u3001\u85e5\u54c1,\u95dc\u9375\u5dee\u7570\u5728\u65bc\u300c\u662f\u5426\u8072\u7a31\u75be\u75c5\u6cbb\u7642\u300d<\/li>\n<li><strong>GRAS \u8a8d\u5b9a\u4e0d\u7b49\u65bc\u7121\u9650\u91cf\u4f7f\u7528<\/strong>,\u9700\u78ba\u8a8d\u5b89\u5168\u7528\u91cf\u7bc4\u570d<\/li>\n<li><strong>\u81b3\u98df\u88dc\u5145\u5291\u53ef\u505a\u5065\u5eb7\u5ba3\u7a31,\u4f46\u4e0d\u5f97\u8072\u7a31\u6cbb\u7642\u75be\u75c5<\/strong>,\u5426\u5247\u8996\u70ba\u672a\u7d93\u6279\u51c6\u7684\u65b0\u85e5<\/li>\n<li><strong>\u6240\u6709\u8def\u5f91\u90fd\u9700\u5b8c\u6210 FDA \u98df\u54c1\u8a2d\u65bd\u8a3b\u518a<\/strong>,\u9032\u53e3\u7522\u54c1\u9700\u5efa\u7acb FSVP<\/li>\n<\/ul>\n<p>\u82e5\u5c0d FDA \u98df\u54c1\u5408\u898f\u4ecd\u6709\u7591\u554f,\u6b61\u8fce\u53c3\u8003 <a href=\"https:\/\/greenoo.tw\/zh\/\" target=\"_blank\" rel=\"noopener\">\u7da0\u5708\u5708\u5b98\u7db2<\/a> \u7684\u5c08\u696d\u9867\u554f\u670d\u52d9\u3002<\/p>\n<hr \/>\n<h2>\u53c3\u8003\u8cc7\u6599<\/h2>\n<p>\u672c\u6587\u5167\u5bb9\u57fa\u65bc\u4ee5\u4e0b FDA \u5b98\u65b9\u8cc7\u6599\u64b0\u5beb(\u622a\u81f3 2026 \u5e74 1 \u6708):<\/p>\n<ol>\n<li>U.S. Food and Drug Administration. &#8220;Dietary Supplements.&#8221; <em>FDA.gov<\/em>, <a href=\"https:\/\/www.fda.gov\/food\/dietary-supplements\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/food\/dietary-supplements<\/a><\/li>\n<li>U.S. Food and Drug Administration. &#8220;FSMA Final Rule on Preventive Controls for Human Food.&#8221; <em>FDA.gov<\/em>, <a href=\"https:\/\/www.fda.gov\/food\/food-safety-modernization-act-fsma\/fsma-final-rule-preventive-controls-human-food\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/food\/food-safety-modernization-act-fsma\/fsma-final-rule-preventive-controls-human-food<\/a><\/li>\n<li>Code of Federal Regulations Title 21, Part 101. &#8220;Food Labeling.&#8221; <em>eCFR<\/em>, <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-B\/part-101\" target=\"_blank\" rel=\"noopener\">https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-B\/part-101<\/a><\/li>\n<li>U.S. Food and Drug Administration. &#8220;Generally Recognized as Safe (GRAS).&#8221; <em>FDA.gov<\/em>, <a href=\"https:\/\/www.fda.gov\/food\/generally-recognized-safe-gras\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/food\/generally-recognized-safe-gras<\/a><\/li>\n<li>Code of Federal Regulations Title 21, Part 111. &#8220;Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.&#8221; <em>eCFR<\/em>, <a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-B\/part-111\" target=\"_blank\" rel=\"noopener\">https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-B\/part-111<\/a><\/li>\n<\/ol>\n<p><em>\u8a3b:FDA \u6cd5\u898f\u53ef\u80fd\u66f4\u65b0,\u5efa\u8b70\u67e5\u95b1\u6700\u65b0\u5b98\u65b9\u6587\u4ef6\u6216\u8aee\u8a62\u5c08\u696d<\/em><\/p>","protected":false},"excerpt":{"rendered":"<p>\u76f4\u63a5\u56de\u7b54:FDA \u6c92\u6709\u300c\u552f\u4e00\u8a8d\u53ef\u300d\u7684\u4e2d\u85e5\u6750 \u7b54\u6848\u662f:\u7f8e\u570b FDA \u4e26\u6c92\u6709\u300c\u552f\u4e00\u8a8d\u53ef\u300d\u7684\u4e2d\u85e5\u6750\u3002 \u9019\u662f\u4e00\u500b\u5e38\u898b\u7684 [&hellip;]<\/p>","protected":false},"author":11,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","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":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center 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