FDA发布一份工业指南草案-关于外用、不需要批准即可上市的OTC类药品中...

The FDA Issues Draft Guidance About the Absorption of Active Ingredients Being C**idered for Inclusion in Over-the-Counter Drug Products Applied to the Skin and Marketed without Approved Applicati**

FDA发布一份工业指南草案-关于外用不需要批准即可上市的OTC类药品中活性成分的吸收问题

2018.05.22 issued by FDA voice

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All drugs have some risk — even over-the-counter (OTC) drugs available without a prescription — and the FDA is always taking steps to help ensure their safety. When you take a pill, you generally expect that some of the active ingredient gets into your body, but what about when you apply a topical product to the skin? How much of the product gets absorbed through the skin and enters the bloodstream, and is it safe? At the FDA, we’ve been working to better understand the absorption and safety profile of topical OTC products such as sunscreens and topical antiseptics. We are particularly interested in learning how these products affect vulnerable populati** such as children, the elderly, and pregnant and breastfeeding women.

所有的药品都有风险，更何况OTC这类不需要处方就可以使用的药品。FDA一直采取措施以确保它们的安全。当你服用药片的时候，你通常会认为一些活性有效成分会进入你的体内，但是当你使用一个外用皮肤用药的时候呢，又该如何？有多少药品吸收进入了皮肤并进入和血液，它是否安全？在FDA我们已经致力于更好的理解外用OTC类药物的吸收和安全概况，例如那些防晒霜和外用防腐剂。我们对了解这些产品如何影响易受伤害人群（如儿童、老人、孕妇和哺乳期女士）更感兴趣。

Until recently, there was little data available to dem**trate the extent to which topical OTC drugs are absorbed into the bloodstream after application, and whether there are any long-term c**equences of this. In fact, many topical OTC products were first marketed when these products were thought not to be absorbed through the skin and when there were no effective methods available to measure absorption. Now, better measurement tools are available, and research indicates that topical drugs can indeed be absorbed into the body through the skin.

到目前为止，仅有很少可利用的数据能够在一定程度上阐述外用OTC类药物在使用后是如何进入血液的，是否有任何长期的影响。事实上，许多的外用OTC类药物都是首次上市，当时这些产品被认为并不能被皮肤吸收，而且并没有有效的可利用的方法来检测它门的吸收情况。现在，有更好的方法可以利用，并且研究显示外用药确实能够通过皮肤进入体内。

C**equently, the FDA has been generally encouraging manufacturers to collect data on the potential risks of a topical drug when used according to the maximum limits of the product’s instructi**, what we call Maximal Usage Trials or MUsT studies. Most recently we included MUsT studies among the list of safety and efficacy studies recommended for sunscreen active ingredients being evaluated under a new marketing pathway established by the Sunscreen Innovation Act in a final guidance for industry in November 2016. Now we are issuing draft guidance that, when finalized, will provide recommendati** to industry on how to design and conduct MUsT studies for topical active ingredients that are under c**ideration for inclusion in an OTC monograph.

因此，FDA鼓励制造商收集依照产品说明书最大限度使用情况下外用药的存在潜在风险的数据，我们称之为最大剂量试验或者MUsT研究。最近，我们将该研究列入一份关于防晒成分的安全性和有限性研究清单，该研究是根据2016年11月在行业最终指南中《防晒创新法》中制定的一种新的营销途径进行评估的。

The draft guidance includes discussi** about how to study the topical active ingredient’s effects on specific subgroups of vulnerable patients like children and the elderly. The studies require a relatively small sample of patients for a short period of time and should not be overly burdensome. In fact, this draft guidance reflects the same safety and efficacy standards that have applied to all drug products marketed under the OTC Monograph System for more than 40 years.

指南草案内容包括讨论关于如何研究外用活性成分对易受伤害人群例如儿童和老人的影响。该研究需要对相对少数病人进行短期的研究，不会太繁重。事实上，该草案反映了与已经应用于40多年的所有OTC各论系统上市的药品相同的安全和有效的标准。

Absorption studies have contributed significantly to the FDA’s knowledge of the safety of topical prescription products. Applying a similar level of safety research to active ingredients being c**idered for inclusion in an OTC monograph to that which currently exists for prescription products can help the FDA determine whether these ingredients should be included in OTC products marketed without approved applicati**.

吸收研究对FDA了解外用处方药品贡献巨大。对目前存在于处方产品的非处方产品的有效成分进行了类似的安全研究，可以帮助FDA确定这些成分是否应该包括在没有经过批准的OTC产品中。

4 e' F) e  q) ]5 z6 W: f8 GFDA的MUsT（Maximal Usage Trials）工业指南草案请参见附件

5 a$ s' D& A7 X. k; g" k) MPS：中文版翻译后续将上传。