{"id":7504,"date":"2024-08-22T20:14:17","date_gmt":"2024-08-22T12:14:17","guid":{"rendered":"https:\/\/regask.com\/?p=7504"},"modified":"2025-01-09T03:26:17","modified_gmt":"2025-01-08T19:26:17","slug":"%e6%b3%b0%e5%9b%bd-fda-%e8%8d%af%e5%93%81%e6%a0%87%e7%ad%be%e6%8c%87%e5%8d%97","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/thailand-fda-drug-labeling-guidelines\/","title":{"rendered":"\u6cf0\u56fd FDA \u52a0\u5f3a\u836f\u54c1\u6807\u7b7e\u548c PIL \u89c4\u5219\uff1a\u65b0\u2026\u2026"},"content":{"rendered":"<p>2024\u5e748\u670820\u65e5\uff0c\u6cf0\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40\uff08FDA\uff09\u5bf9\u6700\u521d\u4e8e2023\u5e746\u670823\u65e5\u5236\u5b9a\u7684\u7535\u5b50\u63d0\u4ea4\u73b0\u4ee3\u836f\u7269\u914d\u65b9\u6ce8\u518c\u6307\u5357\u53d1\u5e03\u4e86\u91cd\u8981\u66f4\u65b0\u3002\u6b64\u6b21\u66f4\u65b0\u7279\u522b\u4fee\u8ba2\u4e86\u67d0\u4e9b\u836f\u54c1\u7c7b\u522b\u7684\u6807\u7b7e\u548c\u60a3\u8005\u4fe1\u606f\u624b\u518c\uff08PIL\uff09\u6807\u51c6\uff0c\u65e8\u5728\u7b80\u5316\u6ce8\u518c\u6d41\u7a0b\uff0c\u786e\u4fdd\u6d88\u8d39\u8005\u4fe1\u606f\u6e05\u6670\u3001\u6613\u61c2\u4e14\u7b26\u5408\u56fd\u9645\u6807\u51c6\u3002\u6b64\u6b21\u4fee\u8ba2\u6709\u671b\u63d0\u5347\u6cf0\u56fd\u5236\u836f\u4e1a\u7684\u7ade\u4e89\u529b\uff0c\u6539\u5584\u516c\u4f17\u83b7\u5f97\u57fa\u672c\u836f\u7269\u7684\u673a\u4f1a\u3002<\/p>\n<p>\u66f4\u65b0\u540e\u7684\u6307\u5357\u91cd\u70b9\u901a\u8fc7\u4ee5\u4e0b\u65b9\u5f0f\u5b8c\u5584\u73b0\u4ee3\u836f\u54c1\u7684\u6807\u7b7e\u548c\u60a3\u8005\u4fe1\u606f\u624b\u518c\uff1a<\/p>\n<ul>\n<li><strong>PIL \u7684\u516c\u5171\u7528\u6237\u6d4b\u8bd5<\/strong>\uff1a\u6700\u65b0\u89c4\u5b9a\u8981\u6c42\uff0c\u5bf9\u4e8e\u5bb6\u5ead\u7528\u836f\u4ee5\u53ca\u672a\u88ab\u5f52\u7c7b\u4e3a\u5371\u9669\u54c1\u6216\u53d7\u7279\u6b8a\u7ba1\u5236\u7684\u836f\u54c1\uff08\u5305\u62ec\u6700\u8fd1\u4ece\u6b64\u7c7b\u5206\u7c7b\u4e2d\u964d\u7ea7\u7684\u836f\u54c1\uff09\uff0c\u60a3\u8005\u4fe1\u606f\u624b\u518c\u5fc5\u987b\u7ecf\u8fc7\u516c\u4f17\u7528\u6237\u6d4b\u8bd5\u3002<\/li>\n<li><strong>\u6d4b\u8bd5\u89c4\u8303<\/strong>\uff1a\u7528\u6237\u6d4b\u8bd5\u5fc5\u987b\u4f7f\u7528\u4e0e\u6700\u7ec8\u4ea7\u54c1\u5c3a\u5bf8\u3001\u7eb8\u5f20\u8d28\u91cf\u3001\u989c\u8272\u548c\u5b57\u4f53\u6837\u5f0f\u5b8c\u5168\u4e00\u81f4\u7684\u6750\u6599\u8fdb\u884c\u3002\u5fc5\u987b\u7f16\u5236\u5e76\u63d0\u4ea4\u4e00\u4efd\u5168\u9762\u7684\u6d4b\u8bd5\u62a5\u544a\u4ee5\u4f9b PIL \u4f7f\u7528\u3002<\/li>\n<\/ul>\n<p>\u6b64\u6b21\u8c03\u6574\u65e8\u5728\u786e\u4fdd\u6807\u7b7e\u548c\u516c\u5171\u4fe1\u606f\u8bf4\u660e\u4e66\u4e2d\u63d0\u4f9b\u7684\u4fe1\u606f\u6e05\u6670\u3001\u6613\u4e8e\u7406\u89e3\u4e14\u7ecf\u5f97\u8d77\u516c\u4f17\u5ba1\u67e5\uff0c\u4ece\u800c\u4fc3\u8fdb\u7b26\u5408\u6cf0\u56fd\u793e\u4f1a\u9700\u6c42\u7684\u81ea\u6211\u62a4\u7406\u548c\u75be\u75c5\u9884\u9632\u3002<\/p>\n<p>\u6b64\u6b21\u66f4\u65b0\u6807\u5fd7\u7740\u5bb6\u5ead\u7528\u836f\u548c\u5176\u4ed6\u975e\u5371\u9669\u6216\u975e\u7279\u6b8a\u7ba1\u5236\u836f\u7269\uff08\u5c24\u5176\u662f\u6700\u8fd1\u91cd\u65b0\u5206\u7c7b\u7684\u836f\u7269\uff09\u53d1\u751f\u4e86\u91cd\u5927\u8f6c\u53d8\u3002\u5236\u836f\u4f01\u4e1a\u73b0\u5728\u5fc5\u987b\u5bf9\u516c\u5171\u4fe1\u606f\u8d44\u6599\u8fdb\u884c\u516c\u4f17\u7528\u6237\u6d4b\u8bd5\uff0c\u786e\u4fdd\u8fd9\u4e9b\u4fe1\u606f\u6750\u6599\u7b26\u5408\u516c\u4f17\u7406\u89e3\u6807\u51c6\u3002<\/p>\n<a href=\"https:\/\/regask.com\/zh\/%e6%8e%a5%e8%a7%a6\/\" target=\"_blank\" class=\"button primary is-link is-medium\" rel=\"noopener\" >\n\t\t<span>\u9605\u8bfb\u66f4\u591a<\/span>\n\t<\/a>\n\n<p>\u00a9\u672c RegAlert \u7531 RegASK \u53d1\u5e03<\/p>","protected":false},"excerpt":{"rendered":"<p>On August 20, 2024, the Food and Drug Administration (FDA) of Thailand issued an important update to the guidelines for electronically submitted modern drug formula registrations, originally established on June 23, 2023. This update specifically revises the standards for labeling and patient information leaflets (PILs) across certain drug categories, aiming to streamline the registration process&#8230;<\/p>","protected":false},"author":22,"featured_media":7514,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[35,535],"tags":[480,479,474,299,177],"class_list":["post-7504","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma-biotech-latest-insights","category-thailand-regulations","tag-product-information-leaflet","tag-household-medicine","tag-product-compliance","tag-regulatory-intelligence","tag-labelling"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Thailand FDA Enhances Drug Labeling Guidelines | 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