{"id":536,"date":"2025-12-26T18:12:13","date_gmt":"2025-12-26T10:12:13","guid":{"rendered":"https:\/\/www.fda-registered.com\/?p=536"},"modified":"2025-12-29T11:04:03","modified_gmt":"2025-12-29T03:04:03","slug":"otc-monograph-fda-registration-process","status":"publish","type":"post","link":"https:\/\/www.fda-registered.com\/en\/otc-monograph-fda-registration-process\/","title":{"rendered":"FDA OTC Monographs \u975e\u5904\u65b9\u4e13\u8bba\u836f\u54c1\u6ce8\u518c\u5168\u6d41\u7a0b\u89e3\u6790"},"content":{"rendered":"<h2 class=\"wp-block-heading\">\u4e00\u3001\u4ec0\u4e48\u662f FDA OTC Monographs\u975e\u5904\u65b9\u4e13\u8bba\u836f\u54c1\uff1f<\/h2>\n\n\n\n<p>FDA OTC Monographs \u975e\u5904\u65b9\u4e13\u8bba\u836f\u54c1\u662f\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u9488\u5bf9\u975e\u5904\u65b9\u836f\uff08Over-the-Counter, OTC\uff09\u5236\u5b9a\u7684\u4e00\u5957\u6cd5\u89c4\u6846\u67b6\u3002<br>\u901a\u8fc7 Monographs \u4e13\u8bba\u8def\u5f84\u6ce8\u518c\u7684\u836f\u54c1\u65e0\u9700\u9010\u4e00\u63d0\u4ea4 NDA\uff08\u65b0\u836f\u7533\u8bf7\uff09\uff0c\u53ea\u8981\u7b26\u5408 <strong>Monograph \u51c6\u8f6e\u6807\u51c6<\/strong> \u5373\u53ef\u5408\u6cd5\u9500\u552e\u3002<\/p>\n\n\n\n<p>Monographs \u51c6\u8f6e\u76f8\u5f53\u4e8e\u4e00\u4efd\u201c\u5904\u65b9\u6307\u5357\u201d\uff0c\u660e\u786e\u4e86\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u6d3b\u6027\u6210\u5206\u53ca\u5242\u91cf\u8303\u56f4<\/strong><\/li>\n\n\n\n<li><strong>\u9002\u5e94\u75c7<\/strong><\/li>\n\n\n\n<li><strong>\u4f7f\u7528\u8bf4\u660e\u53ca\u8b66\u793a<\/strong><\/li>\n\n\n\n<li><strong>\u6807\u7b7e\u8981\u6c42<\/strong><\/li>\n<\/ul>\n\n\n\n<p>\ud83d\udc49 \u5ef6\u4f38\u9605\u8bfb\uff1a<a href=\"https:\/\/www.fda-registered.com\/en\/drug-fda-registration-process\/\">FDA OTC \u836f\u54c1\u6ce8\u518c\u5168\u6d41\u7a0b\u89e3\u6790<\/a><\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">\u4e8c\u3001\u9002\u7528\u8303\u56f4<\/h2>\n\n\n\n<p>Monographs \u4e13\u8bba\u4e3b\u8981\u9002\u7528\u4e8e\u5e38\u89c1\u7684 OTC \u836f\u54c1\uff0c\u4f8b\u5982\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u611f\u5192\u836f\u3001\u6b62\u54b3\u836f<\/li>\n\n\n\n<li>\u6297\u8fc7\u654f\u836f<\/li>\n\n\n\n<li>\u5916\u7528\u6740\u83cc\u3001\u6d88\u708e\u836f<\/li>\n\n\n\n<li>\u76ae\u80a4\u62a4\u7406\u53ca\u6d88\u6bd2\u7c7b\u836f\u54c1<\/li>\n<\/ul>\n\n\n\n<p>\u82e5\u4ea7\u54c1\u4e0d\u7b26\u5408 Monograph \u4e13\u8bba\u89c4\u5b9a\uff0c\u9700\u901a\u8fc7 <strong>NDA \u6216 505(b)(2)<\/strong> \u8def\u5f84\u7533\u8bf7\u6279\u51c6\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">\u4e09\u3001FDA OTC Monographs \u975e\u5904\u65b9\u4e13\u8bba\u836f\u54c1\u6ce8\u518c\u6d41\u7a0b<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">1. \u4ea7\u54c1\u81ea\u67e5<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u786e\u8ba4\u836f\u54c1\u6d3b\u6027\u6210\u5206\u662f\u5426\u5728 Monograph \u4e13\u8bba\u4e2d\u5217\u51fa<\/li>\n\n\n\n<li>\u68c0\u67e5\u5242\u91cf\u3001\u914d\u65b9\u3001\u9002\u5e94\u75c7\u53ca\u6807\u7b7e\u8981\u6c42<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">2. \u914d\u65b9\u4e0e\u6807\u7b7e\u5408\u89c4\u6027<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u8c03\u6574\u836f\u54c1\u914d\u65b9\u4e0e\u5242\u91cf\uff0c\u786e\u4fdd\u5728 Monograph \u4e13\u8bba\u8303\u56f4<\/li>\n\n\n\n<li>\u6807\u7b7e\u7b26\u5408 FDA \u6807\u7b7e\u6307\u5357\uff0c\u5305\u62ec\u8b66\u793a\u3001\u4f7f\u7528\u8bf4\u660e\u3001\u6210\u5206\u8868<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">3. \u6267\u884c cGMP\uff08Current Good Manufacturing Practices\uff09<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u786e\u4fdd\u751f\u4ea7\u8fc7\u7a0b\u7b26\u5408 FDA \u98df\u54c1\/\u836f\u54c1\u8d28\u91cf\u89c4\u8303<\/li>\n\n\n\n<li>\u5efa\u7acb\u751f\u4ea7\u3001\u6d4b\u8bd5\u548c\u8bb0\u5f55\u7ba1\u7406\u4f53\u7cfb<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">4. \u4ea7\u54c1\u4e0a\u5e02\u524d\u901a\u77e5\uff08\u5982\u9002\u7528\uff09<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u5bf9\u67d0\u4e9b OTC \u836f\u54c1\uff0c\u4f01\u4e1a\u53ef\u9009\u62e9\u5411 FDA \u63d0\u4ea4 <strong>Drug Listing<\/strong>\uff0c\u5907\u6848\u4ea7\u54c1\u4fe1\u606f<\/li>\n\n\n\n<li>\u5907\u6848\u53ef\u589e\u52a0\u900f\u660e\u5ea6\uff0c\u51cf\u5c11\u6f5c\u5728\u6cd5\u89c4\u98ce\u9669<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">5. \u4e0a\u5e02\u9500\u552e\u4e0e\u5408\u89c4\u7ef4\u62a4<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4ea7\u54c1\u4e0a\u5e02\u540e\u6301\u7eed\u76d1\u63a7 Adverse Event\uff08\u4e0d\u826f\u4e8b\u4ef6\uff09<\/li>\n\n\n\n<li>\u5b9a\u671f\u5ba1\u67e5\u6807\u7b7e\u53ca\u914d\u65b9\u53d8\u5316\uff0c\u786e\u4fdd\u6301\u7eed\u7b26\u5408 Monograph\u4e13\u8bba<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">\u56db\u3001\u5e38\u89c1\u6311\u6218<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4ea7\u54c1\u6d3b\u6027\u6210\u5206\u672a\u5728 Monograph \u4e13\u8bba\u5217\u51fa<\/li>\n\n\n\n<li>\u914d\u65b9\u6216\u5242\u91cf\u8d85\u51fa Monograph \u4e13\u8bba\u8303\u56f4<\/li>\n\n\n\n<li>\u6807\u7b7e\u8b66\u793a\u548c\u8bf4\u660e\u4e0d\u7b26\u5408 FDA \u8981\u6c42<\/li>\n\n\n\n<li>\u751f\u4ea7\u5de5\u827a\u4e0d\u7b26\u5408 cGMP<\/li>\n<\/ul>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">\u4e94\u3001\u6210\u529f\u6848\u4f8b\u5206\u4eab<\/h2>\n\n\n\n\t\t\t<div class=\"wp-block-uagb-post-carousel uagb-post-grid  uagb-post__image-position-top uagb-post__image-enabled uagb-block-bf37b47b     uagb-post__arrow-outside uagb-post__items uagb-post__columns-3 is-carousel uagb-post__columns-tablet-2 uagb-post__columns-mobile-1\" data-total=\"1\" style=\"\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<article class=\"uagb-post__inner-wrap\">\t\t\t\t\t\t\t\t<div class='uagb-post__image'>\n\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.fda-registered.com\/en\/jianyuan-company-registratio-ndc-registration\/\" target=\"_self\" rel=\"bookmark noopener noreferrer\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"576\" src=\"https:\/\/www.fda-registered.com\/wp-content\/uploads\/2025\/08\/WechatIMG4689-1024x576.jpg\" class=\"attachment-large size-large\" alt=\"\u5e7f\u5dde\u5065\u6e90\u751f\u7269\u6280\u672f\u836f\u54c1\u4f01\u4e1a\u6ce8\u518c\u53caNDC\u6ce8\u518c\" srcset=\"https:\/\/www.fda-registered.com\/wp-content\/uploads\/2025\/08\/WechatIMG4689-1024x576.jpg 1024w, https:\/\/www.fda-registered.com\/wp-content\/uploads\/2025\/08\/WechatIMG4689-300x169.jpg 300w, https:\/\/www.fda-registered.com\/wp-content\/uploads\/2025\/08\/WechatIMG4689-768x432.jpg 768w, https:\/\/www.fda-registered.com\/wp-content\/uploads\/2025\/08\/WechatIMG4689-1536x864.jpg 1536w, https:\/\/www.fda-registered.com\/wp-content\/uploads\/2025\/08\/WechatIMG4689.jpg 1920w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/>\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<h4 class=\"uagb-post__title uagb-post__text\">\n\t\t\t\t<a href=\"https:\/\/www.fda-registered.com\/en\/jianyuan-company-registratio-ndc-registration\/\" target=\"_self\" rel=\"bookmark noopener noreferrer\">Guangzhou Jianyuan Biotechnology Pharmaceutical Enterprise Registration and NDC Registration<\/a>\n\t\t\t<\/h4>\n\t\t\t\t\t\t<div class='uagb-post__text uagb-post-grid-byline'>\n\t\t\t\t\t\t\t\t<time datetime=\"2025-08-25T15:42:27+08:00\" class=\"uagb-post__date\">\n\t\t\t\t<span class=\"dashicons-calendar dashicons\"><\/span>\t\t\t\t\tAugust 25, 2025\t\t\t\t<\/time>\n\t\t\t\t\t\t\t<span class=\"uagb-post__comment\">\n\t\t\t\t<span class=\"dashicons-admin-comments dashicons\"><\/span>\t\t\t\t\tNo Comments\t\t\t\t<\/span>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class='uagb-post__text uagb-post__excerpt'>\n\t\t\t\t\tGuangzhou Jianyuan Biotechnology Co., Ltd. has successfully completed pharmaceutical enterprise registration and NDC registration. Our team provides professional FDA registration guidance services, assisting companies with document preparation, system operation, and compliance review to ensure rapid registration approval.\t\t\t\t<\/div>\n\t\t\t\t\t\t<div class=\"uagb-post__text uagb-post__cta wp-block-button\">\n\t\t\t\t<a class=\"wp-block-button__link uagb-text-link\" style=\"\" href=\"https:\/\/www.fda-registered.com\/en\/jianyuan-company-registratio-ndc-registration\/\" target=\"_self\" rel=\"bookmark noopener noreferrer\">Read more<\/a>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t\t\t\t<\/article>\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\n\n\n<p>\ud83d\udc49 \u67e5\u770b\u8be6\u7ec6\u8f85\u5bfc\u4e0e\u6d41\u7a0b\u89e3\u6790\uff1a<a href=\"https:\/\/www.fda-registered.com\/en\/drug-fda-registration-process\/\">FDA OTC \u836f\u54c1\u6ce8\u518c\u670d\u52a1<\/a><\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\">\u516d\u3001\u603b\u7ed3\u4e0e\u884c\u52a8\u5efa\u8bae<\/h2>\n\n\n\n<p>FDA OTC Monographs \u975e\u5904\u65b9\u4e13\u8bba\u836f\u54c1\u63d0\u4f9b\u4e86\u4e00\u6761\u7b80\u5316\u7684\u6ce8\u518c\u8def\u5f84\uff0c\u4f46\u5408\u89c4\u8981\u6c42\u4e25\u683c\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u6838\u5bf9\u6d3b\u6027\u6210\u5206\u3001\u5242\u91cf\u4e0e\u9002\u5e94\u75c7<\/li>\n\n\n\n<li>\u6807\u7b7e\u3001\u8b66\u793a\u548c\u8bf4\u660e\u4e66\u5fc5\u987b\u5b8c\u5168\u7b26\u5408 Monograph\u975e\u5904\u65b9\u4e13\u8bba\u836f\u54c1<\/li>\n\n\n\n<li>\u4fdd\u6301\u751f\u4ea7\u548c\u8bb0\u5f55\u4f53\u7cfb\u7b26\u5408 cGMP<\/li>\n<\/ul>\n\n\n\n<p>\u2705 \u4f01\u4e1a\u82e5\u8ba1\u5212\u51fa\u53e3 OTC \u836f\u54c1\u7f8e\u56fd\u5e02\u573a\uff0c\u5efa\u8bae\u63d0\u524d\u8bc4\u4f30 Monograph \u4e13\u8bba\u5408\u89c4\u6027\uff0c\u5e76\u5bfb\u6c42\u4e13\u4e1a\u8f85\u5bfc\uff0c\u964d\u4f4e\u4e0a\u5e02\u98ce\u9669\u3002<\/p>","protected":false},"excerpt":{"rendered":"<p>\u672c\u6587\u7cfb\u7edf\u4ecb\u7ecd\u4e86 FDA OTC Monographs \u836f\u54c1\u6ce8\u518c\u5168\u6d41\u7a0b\uff0c\u5305\u62ec\u914d\u65b9\u4e0e\u5242\u91cf\u68c0\u67e5\u3001\u6807\u7b7e\u4f18\u5316\u3001cGMP\u6267\u884c\u3001\u4e0a\u5e02\u5907\u6848\u53ca\u6210\u529f\u6848\u4f8b\uff0c\u52a9\u529b\u4f01\u4e1a\u9ad8\u6548\u5408\u89c4\uff0c\u5feb\u901f\u8fdb\u5165\u7f8e\u56fd\u5e02\u573a\u3002<\/p>","protected":false},"author":1,"featured_media":535,"comment_status":"open","ping_status":"open","sticky":false,"template":"template-single-sidebar","format":"standard","meta":{"_uag_custom_page_level_css":"","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":"","ast-disable-related-posts":"","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":"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-opacity":"","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-opacity":"","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-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center 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