at https://direct.fda.gov/, for registration and listing of cosmetic product facilities and products. We have also developed a user’s guide to Cosmetics Direct, a facility registration tutorial, and a product listing tutorial (See links in Related Resources section below).2023 年 ...
In December 2023, FDA also announced the launch of its Cosmetics Direct electronic submission portal, at https://direct.fda.gov/, for registration and listing of cosmetic product facilities and products. We have also developed a user’s guide to Cosmetics Direct, a facility registration tutorial,...
MOCRA法规：MOCRA（Mandatory Registration of Cosmetic Products Act）是一项要求化妆品在美国市场进行注册的法规。该法规要求化妆品制造商或分销商向FDA进行注册，并提供相关产品信息和安全报告。安全性和质量要求：FDA要求所有在美国销售的化妆品必须符合一定的安全性和质量要求。这包括确保产品成分的安全性、无害性和标签...
(RPM)是FDA人员的参考手册,为FDA人员提供了在处理国内和进口监管和执法事务中使用的内部程序信息、Federal Food, Drug, and Cosmetic Act (FD&C Act)(联邦食品、药品和化妆品法(FD&C法))、FDA Compliance Policy Guides (CPG) (FDA合规政策指南(CPG))及 Regulatory Procedures Manual (RPM)(监管程序手册(RPM))...
美国FDA 指导原则 根据联邦食品、药品和化妆品法指南第503A条规定的人类药物产品的药房配方 英文原版.pdf,Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance U.S. Department of Health and Human Se
This guidance applies to clinical investigations regulated by FDA under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the Act). III. WHEN CAN IRB REQUIREMENTS BE WAIVED? IRB review and approval is generally required before a study can be initiated under an Investigational New ...
https://www.fda.gov/cosmetics/voluntary-cosmetic-registration-program 6. 化妆品被拒绝进入美国的原因? 如果化妆品在任何方面疑似不符合适用的美国法律法规,其可能被拒绝进入美国。以下是化妆品被拒绝进入美国的一些*常见原因: ·成分或污染物导致产品不安全。
美国化妆品FDA产品类型分类: 01. Baby Products婴儿产品 a. Baby Shampoos 洗发露 b. Lotions, Oils, Powders, and Creams护肤类爽身粉,面霜,涂油,涂液 c. Other Suntan Preparations 其他防晒用品 专业办理各国产品检测认证,一站式服务。
- 欧盟化妆品法规:化妆品需要进行欧盟内部的产品安全评估(Safety Assessment),并提交CPNP(Cosmetic Products Notification Portal)备案。法规强调产品的安全性评估和成分安全性。**3. 成分禁限:** - FDA备案:美国FDA在化妆品中对一些成分施加限制和禁止,例如某些色素和某些添加剂。 - 欧盟化妆品法规:欧盟对一些化妆品...
FDA食品接触材料测试指引 一、美国食品接触材料管理条例 1、美国食品级-联邦法典CFR(Code of Federal Regulations)，美国《联邦食品、药品和化妆品法》(Federal Food, Drug, and Cosmetic Act)是美国关于食品(包括食品添加剂)和药品的基本法。按照这一法律的要求，美国食品药品管理局(FDA)详细制定了若干规章。美国联邦...