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FDA公布第二次防晒霜吸收的研究结果

首页 > 资讯 > FDA公布第二次防晒霜吸收的研究结果

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FDA公布第二次防晒霜吸收的研究结果
Janet Woodcock, M.D.
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2020-01-21 FDA

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FDA announces results from second sunscreen absorption study

The following quote is attributed to Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

“Given the recognized public health benefits of sunscreen use, the U.S. Food and Drug Administration (FDA) urges Americans to use sunscreens in conjunction with other sun protective measures (such as protective clothing). To support sunscreen safety, the FDA tested whether various sunscreen ingredients can be absorbed through the skin into the body.”

“Results from our study released today show there is evidence that some sunscreen active ingredients may be absorbed. However, the fact that an ingredient is absorbed through the skin and into the body does not mean that the ingredient is unsafe, nor does the FDA seeking further information indicate such. Rather, this finding calls for further industry testing to determine the safety and effect of systemic exposure of sunscreen ingredients, especially with chronic use.”

“That’s why as part of the proposed rule on sunscreen, the FDA requested additional information on active ingredients in sunscreen to evaluate their GRASE (Generally Recognized As Safe and Effective) status in light of changed conditions, including substantially increased sunscreen usage and evolving information about the potential risks associated with these products since they were originally evaluated. We look to sharing further updates on this important area of research. ”

  • Today, the FDA published the study, “Effect of Sunscreen Application on Plasma Concentration of Sunscreen Active Ingredients: A Randomized Clinical Trial” in the Journal of the American Medical Association (JAMA). This study describes the results of a clinical trial evaluating the absorption through the skin and into the body of six sunscreen active ingredients under single dose and maximal use conditions. The study included ingredients not previously evaluated. A prior pilot study was published in JAMA in May 2019.
  • The study used four commercially available sunscreen products (lotion, aerosol spray, non-aerosol spray and pump spray). The publication results show that when sunscreen is applied to the skin, even a single application, all six tested active ingredients and all of the formulations, result in measurable blood levels of the active ingredient.

Related Information

  • Sunscreen Drug Products for Over-the-Counter Human Use Proposed Rule
  • Sunscreen: How to Help Protect Your Skin from the Sun
  • FDA: Shedding More Light on Sunscreen Absorption

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

【来源】
FDA announces results from second sunscreen absorption study

【相关内容】
New FDA Study Shines Light on Sunscreen Absorption

必读岗位及工作建议:

  • QA(质量保证):负责确保原料药生产全过程符合质量管理规范,监控质量体系运行。
  • QC(质量控制):负责原料药的质量检测,确保产品质量符合标准。
  • 生产:负责按照GMP要求进行原料药的生产操作,确保生产过程合规。
  • 工程:负责厂房设施和设备的维护保养,确保生产环境和设备符合要求。

适用范围:
本文适用于化学药领域的原料药生产,包括创新药和仿制药,适用于大型药企、跨国药企以及CRO和CDMO等企业类别,发布机构为国际通用标准。

文件要点总结:
原料药的生产质量管理规范强调了从质量管理到生产控制的全过程管理。首先,文件明确了质量管理的原则和机构职责,特别强调了质量保证和质量控制的重要性,并规定了自检、产品质量回顾以及质量风险管理的具体要求。在人员方面,规定了资质、培训和卫生要求,确保员工符合岗位需求。厂房与设施章节详细规定了设计建造、公用设施和特殊隔离要求,以保证生产环境的适宜性。设备章节则涉及设计建造、维护保养、校准和计算机化系统的要求,确保设备运行的可靠性。文件还特别提到了无菌原料药的生产特点,包括生产工艺、厂房设施设备设计、生产过程管理以及环境控制等,这些都是确保原料药质量的关键环节。

以上仅为部分要点,请阅读原文,深入理解监管要求。

取自“https://login.shilinx.com/wiki/index.php?title=FDA%E5%85%AC%E5%B8%83%E7%AC%AC%E4%BA%8C%E6%AC%A1%E9%98%B2%E6%99%92%E9%9C%9C%E5%90%B8%E6%94%B6%E7%9A%84%E7%A0%94%E7%A9%B6%E7%BB%93%E6%9E%9C”
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