{"id":234,"date":"2025-08-22T18:22:45","date_gmt":"2025-08-22T10:22:45","guid":{"rendered":"https:\/\/www.fda-registered.com\/?p=234"},"modified":"2025-08-27T16:16:27","modified_gmt":"2025-08-27T08:16:27","slug":"drug-fda-registration-process","status":"publish","type":"post","link":"https:\/\/www.fda-registered.com\/en\/drug-fda-registration-process\/","title":{"rendered":"\u836f\u54c1FDA\u6ce8\u518c\u5168\u6d41\u7a0b\u89e3\u6790"},"content":{"rendered":"<div class=\"wp-block-uagb-container uagb-block-4f7a1683 alignfull uagb-is-root-container\"><div class=\"uagb-container-inner-blocks-wrap\">\n<h2 class=\"wp-block-heading\">\u836f\u54c1FDA\u6ce8\u518c\u6982\u5ff5<\/h2>\n\n\n\n<p><strong>FDA\u6ce8\u518c<\/strong>\u662f\u6307\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u5bf9\u836f\u54c1\u751f\u4ea7\u4f01\u4e1a\u3001\u836f\u54c1\u8fdb\u53e3\u5546\u53ca\u836f\u54c1\u4ea7\u54c1\u8fdb\u884c\u7684\u5b98\u65b9\u767b\u8bb0\u548c\u5ba1\u6279\u3002\u6ce8\u518c\u6210\u529f\u540e\uff0c\u4f01\u4e1a\u53ef\u5408\u6cd5\u9500\u552e\u6216\u8fdb\u53e3\u836f\u54c1\u81f3\u7f8e\u56fd\u5e02\u573a\u3002<\/p>\n\n\n\n<p>\u5e38\u89c1\u836f\u54c1\u6ce8\u518c\u7c7b\u578b\u5305\u62ec\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>IND\uff08Investigational New Drug\uff09<\/strong>\uff1a\u7528\u4e8e\u4e34\u5e8a\u8bd5\u9a8c\u9636\u6bb5\u836f\u54c1\u7533\u8bf7<\/li>\n\n\n\n<li><strong>NDA\uff08New Drug Application\uff09<\/strong>\uff1a\u65b0\u836f\u4e0a\u5e02\u7533\u8bf7<\/li>\n\n\n\n<li><strong>ANDA\uff08Abbreviated New Drug Application\uff09<\/strong>\uff1a\u4eff\u5236\u836f\u4e0a\u5e02\u7533\u8bf7<\/li>\n\n\n\n<li><strong>OTC\u836f\u54c1\u6ce8\u518c<\/strong>\uff1a\u975e\u5904\u65b9\u836f\u6ce8\u518c<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-container uagb-block-1e891611 alignfull uagb-is-root-container\"><div class=\"uagb-container-inner-blocks-wrap\">\n<h2 class=\"wp-block-heading\">\u836f\u54c1FDA\u6ce8\u518c\u8be6\u7ec6\u6d41\u7a0b<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\">1.\u786e\u8ba4\u4f01\u4e1a\u4e0e\u4ea7\u54c1\u7c7b\u578b<\/h3>\n\n\n\n<p>\u4f01\u4e1a\u9700\u660e\u786e\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4f01\u4e1a\u8eab\u4efd\uff1a\u751f\u4ea7\u4f01\u4e1a\u3001\u8fdb\u53e3\u5546\u6216\u5206\u9500\u5546<\/li>\n\n\n\n<li>\u836f\u54c1\u7c7b\u578b\uff1a\u5904\u65b9\u836f\u3001\u975e\u5904\u65b9\u836f\u6216\u4eff\u5236\u836f<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">2.\u51c6\u5907\u4f01\u4e1a\u4e0e\u836f\u54c1\u4fe1\u606f<\/h3>\n\n\n\n<p>\u63d0\u4ea4<strong>FDA\u6ce8\u518c<\/strong>\u9700\u51c6\u5907\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4f01\u4e1a\u57fa\u672c\u4fe1\u606f\uff08\u540d\u79f0\u3001\u5730\u5740\u3001\u6cd5\u4eba\u4fe1\u606f\uff09<\/li>\n\n\n\n<li>\u4ea7\u54c1\u4fe1\u606f\uff08\u836f\u54c1\u6210\u5206\u3001\u5242\u578b\u3001\u89c4\u683c\u3001\u9002\u5e94\u75c7\uff09<\/li>\n\n\n\n<li>\u836f\u54c1\u4e34\u5e8a\u6570\u636e\u53ca\u751f\u4ea7\u5de5\u827a\u8d44\u6599<\/li>\n\n\n\n<li>\u8bbe\u65bd\u4fe1\u606f\u53caGMP\u7b26\u5408\u6027\u8bc1\u660e<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">3.\u836f\u54c1\u6ce8\u518c\u7c7b\u578b\u7533\u8bf7<\/h3>\n\n\n\n<p>\u4e0d\u540c\u7c7b\u578b\u836f\u54c1\u7533\u8bf7\u6d41\u7a0b\u4e0d\u540c\uff1a<\/p>\n\n\n\n<figure class=\"wp-block-table is-style-stripes\"><table><thead><tr><th>\u6ce8\u518c\u7c7b\u578b<\/th><th>\u9002\u7528\u8303\u56f4<\/th><th>\u6838\u5fc3\u8981\u6c42<\/th><\/tr><\/thead><tbody><tr><td>IND<\/td><td>\u4e34\u5e8a\u8bd5\u9a8c\u9636\u6bb5\u65b0\u836f<\/td><td>\u63d0\u4ea4\u4e34\u5e8a\u65b9\u6848\u3001\u836f\u7406\u6bd2\u7406\u6570\u636e<\/td><\/tr><tr><td>NDA<\/td><td>\u65b0\u836f\u4e0a\u5e02<\/td><td>\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u3001\u836f\u54c1\u8d28\u91cf\u3001\u6807\u7b7e\u8bf4\u660e<\/td><\/tr><tr><td>ANDA<\/td><td>\u4eff\u5236\u836f<\/td><td>\u4e0e\u539f\u7814\u836f\u7b49\u6548\u6027\u6570\u636e\u3001\u836f\u54c1\u8d28\u91cf\u6587\u4ef6<\/td><\/tr><tr><td>OTC<\/td><td>\u975e\u5904\u65b9\u836f<\/td><td>OTC\u836f\u54c1\u914d\u65b9\u3001\u6807\u7b7e\u53ca\u5b89\u5168\u6027\u8d44\u6599<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\">4.\u5728\u7ebf\u6ce8\u518c\u4e0e\u63d0\u4ea4<\/h3>\n\n\n\n<p>\u4f01\u4e1a\u53ef\u901a\u8fc7FDA <strong>FURLS\u7cfb\u7edf<\/strong>\u63d0\u4ea4\u6ce8\u518c\u7533\u8bf7\uff0c\u6b65\u9aa4\u5305\u62ec\uff1a<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>\u586b\u5199\u4f01\u4e1a\u4fe1\u606f\u53ca\u836f\u54c1\u4fe1\u606f<\/li>\n\n\n\n<li>\u4e0a\u4f20\u836f\u54c1\u6587\u4ef6\u3001\u4e34\u5e8a\u6570\u636e\u53caGMP\u8bc1\u660e<\/li>\n\n\n\n<li>\u7f34\u8d39\u5e76\u63d0\u4ea4\u5ba1\u6838<\/li>\n<\/ol>\n\n\n\n<p>\u5883\u5916\u4f01\u4e1a\u9700\u6307\u5b9aUS Agent\u4f5c\u4e3a\u8054\u7cfb\u70b9\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">5.FDA\u5ba1\u6838\u4e0e\u6ce8\u518c\u53f7<\/h3>\n\n\n\n<p>\u6ce8\u518c\u6210\u529f\u540e\uff0cFDA\u4f1a\u5206\u914d\u552f\u4e00\u7684<strong>FDA\u6ce8\u518c\u53f7<\/strong>\uff0c\u7528\u4e8e\u672a\u6765\u4ea7\u54c1\u51fa\u53e3\u3001\u9500\u552e\u53ca\u653f\u5e9c\u76d1\u7ba1\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">6. \u540e\u7eed\u7ef4\u62a4\u4e0e\u66f4\u65b0<\/h3>\n\n\n\n<p>\u836f\u54c1FDA\u6ce8\u518c\u9700\u4fdd\u6301\u4fe1\u606f\u66f4\u65b0\uff0c\u5305\u62ec\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4f01\u4e1a\u6216\u8bbe\u65bd\u4fe1\u606f\u53d8\u66f4<\/li>\n\n\n\n<li>\u836f\u54c1\u4fe1\u606f\u66f4\u65b0<\/li>\n\n\n\n<li>\u5b9a\u671f\u7eed\u6ce8\u518c\uff08\u89c6\u836f\u54c1\u7c7b\u578b\u800c\u5b9a\uff09<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-container uagb-block-4ec13380 alignfull uagb-is-root-container\"><div class=\"uagb-container-inner-blocks-wrap\">\n<h2 class=\"wp-block-heading\">\u836f\u54c1FDA\u6ce8\u518c\u6ce8\u610f\u4e8b\u9879<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u4fe1\u606f\u5b8c\u6574<\/strong>\uff1a\u7f3a\u5931\u4fe1\u606f\u4f1a\u5bfc\u81f4\u6ce8\u518c\u5ef6\u8fdf\u6216\u62d2\u7edd<\/li>\n\n\n\n<li><strong>\u9009\u62e9\u6b63\u786e\u6ce8\u518c\u7c7b\u578b<\/strong>\uff1a\u786e\u4fdd\u9002\u7528\u4e8e\u4f60\u7684\u836f\u54c1<\/li>\n\n\n\n<li><strong>\u9075\u5b88GMP\u89c4\u8303<\/strong>\uff1a\u751f\u4ea7\u4f01\u4e1a\u5fc5\u987b\u7b26\u5408\u7f8e\u56fd\u836f\u54c1GMP\u8981\u6c42<\/li>\n\n\n\n<li><strong>\u6307\u5b9aUS Agent<\/strong>\uff08\u5883\u5916\u4f01\u4e1a\u5fc5\u9700\uff09<\/li>\n\n\n\n<li><strong>\u53ca\u65f6\u66f4\u65b0\u6ce8\u518c\u4fe1\u606f<\/strong><\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-container uagb-block-43e52340 alignfull uagb-is-root-container\"><div class=\"uagb-container-inner-blocks-wrap\">\n<h2 class=\"wp-block-heading\">\u6210\u529f\u6848\u4f8b<\/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-39270aae     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<\/div><\/div>\n\n\n\n<div class=\"wp-block-uagb-container uagb-block-fa1eacb2 alignfull uagb-is-root-container\"><div class=\"uagb-container-inner-blocks-wrap\">\n<h2 class=\"wp-block-heading\">\u5e38\u89c1\u95ee\u9898\uff08FAQ\uff09<\/h2>\n\n\n<div class=\"wp-block-uagb-faq uagb-faq__outer-wrap uagb-block-9fe81595 uagb-faq-icon-row uagb-faq-layout-accordion uagb-faq-expand-first-true uagb-faq-inactive-other-true uagb-faq__wrap uagb-buttons-layout-wrap uagb-faq-equal-height\" data-faqtoggle=\"true\" role=\"tablist\"><div class=\"wp-block-uagb-faq-child uagb-faq-child__outer-wrap uagb-faq-item uagb-block-38e282da\" role=\"tab\" tabindex=\"0\"><div class=\"uagb-faq-questions-button uagb-faq-questions\">\t\t\t<span class=\"uagb-icon uagb-faq-icon-wrap\">\n\t\t\t\t\t\t\t\t<svg xmlns=\"https:\/\/www.w3.org\/2000\/svg\" viewbox= \"0 0 448 512\"><path d=\"M432 256c0 17.69-14.33 32.01-32 32.01H256v144c0 17.69-14.33 31.99-32 31.99s-32-14.3-32-31.99v-144H48c-17.67 0-32-14.32-32-32.01s14.33-31.99 32-31.99H192v-144c0-17.69 14.33-32.01 32-32.01s32 14.32 32 32.01v144h144C417.7 224 432 238.3 432 256z\"><\/path><\/svg>\n\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t<span class=\"uagb-icon-active uagb-faq-icon-wrap\">\n\t\t\t\t\t\t\t\t<svg xmlns=\"https:\/\/www.w3.org\/2000\/svg\" viewbox= \"0 0 448 512\"><path d=\"M400 288h-352c-17.69 0-32-14.32-32-32.01s14.31-31.99 32-31.99h352c17.69 0 32 14.3 32 31.99S417.7 288 400 288z\"><\/path><\/svg>\n\t\t\t\t\t\t\t<\/span>\n\t\t\t<span class=\"uagb-question\">\u836f\u54c1FDA\u6ce8\u518c\u8d39\u7528\u662f\u591a\u5c11\uff1f<\/span><\/div><div class=\"uagb-faq-content\"><p>\u4e0d\u540c\u7c7b\u578b\u836f\u54c1\u6ce8\u518c\u8d39\u7528\u4e0d\u540c\uff0cNDA\u548cANDA\u9700\u7f34\u7eb3\u8f83\u9ad8\u7684\u7533\u8bf7\u8d39\uff0c\u5177\u4f53\u53ef\u54a8\u8be2FDA\u6216\u4e13\u4e1a\u670d\u52a1\u673a\u6784\u3002<\/p><\/div><\/div><div class=\"wp-block-uagb-faq-child uagb-faq-child__outer-wrap uagb-faq-item uagb-block-fe480642\" role=\"tab\" tabindex=\"0\"><div class=\"uagb-faq-questions-button uagb-faq-questions\">\t\t\t<span class=\"uagb-icon uagb-faq-icon-wrap\">\n\t\t\t\t\t\t\t\t<svg xmlns=\"https:\/\/www.w3.org\/2000\/svg\" viewbox= \"0 0 448 512\"><path d=\"M432 256c0 17.69-14.33 32.01-32 32.01H256v144c0 17.69-14.33 31.99-32 31.99s-32-14.3-32-31.99v-144H48c-17.67 0-32-14.32-32-32.01s14.33-31.99 32-31.99H192v-144c0-17.69 14.33-32.01 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