合规进入 - 相关文章

美国FDA、OTC、NDC化妆品申报认证行业资讯,助力企业合规出海

FDA企业注册与工厂登记2026实操指南

2026年美国OTC药品须完成FDA企业注册(Establishment Registration)与工厂登记,作为上市前置条件。本文详解注册主体、邓白氏码要求、系统填报要点与年度更新节奏,帮助出口企业避开常见申报失误。

米诺地尔生发美国OTC合规:2%与5%浓度及NDC注册要点

米诺地尔外用生发产品以2%与5%两种浓度在美国作为OTC药品销售,须符合FDA专论并标注Drug Facts。5%适用于男性,2%多用于女性,均须完成NDC注册与工厂登记。中国防脱发产品出口美国若宣称促生发,须按药品路径合规,不可归入普通化妆品。

21 CFR Part 333 Subpart B - First Aid Antibiotic Drug Products

21 CFR Part 333 Subpart B - First Aid Antibiotic Drug ProductsSubpart B—First Aid Antibiotic Drug Products§ 333.101 Scope.(a) An over-the-counter first aid antibiotic drug product in a form suitable for topical administration is generally recognized

21 CFR Part 333 Subpart D—Topical Acne Drug Products

21 CFR Part 333 Subpart D—Topical Acne Drug ProductsSubpart D—Topical Acne Drug ProductsSource:56 FR 41019, Aug. 16, 1991, unless otherwise noted.§ 333.301 Scope.(a) An over-the-counter acne drug product in a form suitable for topical application is