美国FDA发布日用手消毒剂安全有效性最终规定
美国FDA发布日用手消毒剂安全有效性最终规定来源丨美国FDA授权丨本文翻译来自公众号Julia法规翻译。转载已获得授权，在此表示感谢！FDAissues final rule on safety and effectiveness of consumer hand sanitizersFDA发布日用手消毒剂安全有效性最终规定April 11, 2019FDA官网消息原址https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635793.htmFDA最终规定发布原址https://www.federalregister.gov/documents/2019/04/12/2019-06791/safety-and-effectiveness-of-consumer-antiseptic-rubs-topical-antimicrobial-drug-products-for译注：该规定发布日20190411，发布之后1年生效，详见官网。The U.S. Food and Drug Administration today issued a final rule designed to help ensure that hand sanitizers available over-the-counter (OTC) are safe and effective for those who rely on them. The rule establishes that certain active ingredients are not allowed to be used in OTC hand sanitizers, formally known as topical consumer antiseptic rub products, which are intended for use without water, that are marketed under the FDA’s OTC Drug Review. The final rule also seeks to ensure that the agency’s safety and effectiveness evaluations and determinations for consumer antiseptic rub active ingredients are consistent, up-to-date and appropriately reflect current scientific knowledge and increasing use patterns.美国FDA今天签发了用以帮助确保OTC手消毒剂安全有效性的最终规定。该规定确定了根据FDA的OTC药品审核上市中在OTC手消毒剂中不允许使用哪些活性成分，正式的说法是日用局部杀菌皂产品，它们是在无水情况下使用的。最终规定亦想要确保FDA对日用杀菌皂活性成分的安全性和有效性评估与决定是一致的，最新的以及恰当反映当前科学知识和日渐增长的使用模式。“Our action today aims to help provide consumers with confidence that the over-the-counter hand sanitizers they’re using are safe andeffective when they don’t have access to water to wash with soap,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.“In today’s final regulation we finalized the FDA’s previous determination that 28 active ingredients, including triclosan and benzethonium chloride, are not eligible for evaluation under the FDA’s OTC Drug Review for use in consumer antiseptic rubs. We’ve also reaffirmed our need for more data on three other active ingredients, including ethyl alcohol, which is the most commonly used ingredient in hand sanitizers, to help the agency ensure that these productsare safe and effective for regular use by consumers. We believe industry has made good progress toward providing data and we will continue to provide updates to the public about the progress of collecting this data.”FDA的CDER主任Janet Woodcock, M.D.说，“我们今天采取的措施目的是让消费者相信当没有水用香皂洗手时，他们日常用的OTC手消毒剂的安全性和有效性。在今天的我们发布的最终规定里，FDA确定了之前对28种活性成分的决定，包括三氯生和苄索氯铵，认为他们未通过FDA对日用杀菌液中可用OTC药品的审核。我们亦重申对其它三种活性成分，包括在手消毒剂中最常使用的成分乙醇，尚需要更多数据来帮助FDA确保这些产品在日常使用是安全有效的。我们相信企业在提供数据方面已有了很大进展，我们会持续向公众更新关于这些数据采集方面的进展”。Consumer antiseptic hand sanitizers provide a convenient alternative when hand washing with plain soap and water is unavailable.Millions of Americans use antiseptic rubs daily, sometimes multiple times aday, to help reduce bacteria on their hands. The Centers for Disease Control and Prevention advises that washing hands with plain soapand running water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading infections to others. If soap and water are not available, the CDC recommends using an alcohol-based handsanitizer that contains at least 60 percent alcohol.日用杀菌手消毒剂提供了在没有普通香皂和水情况下简便的替代方法。成千上万美国人每天使用杀菌皂，有时一天数次，用以帮助降低手上的细菌数量。疾控中心（CDC）建议采用普通香皂洗手然后用水冲洗是一个最重要的步骤，如此可避免生病，防止感染他人。如果没有香皂和水，CDC建议使用含至少60%酒精的手消毒剂。As part of the June 30, 2016 proposed rule onconsumer antiseptic rubs, the FDA requested additional scientific data to support the safety and effectiveness of active ingredients used in OTC consumer antiseptic rubs.作为2016年6月30日日用杀菌液规定草案的一部分，FDA已索取更多科学数据来支持OTC日用杀菌皂中所用活性成分的安全性和有效性。At this time, three active ingredients—benzalkonium chloride, ethyl alcohol, and isopropyl alcohol—are being deferred from further rulemaking to allow for the ongoing study and submission of additional safetyand effectiveness data necessary to make a determination regarding whether these active ingredients are generally recognized as safe and effective for usein OTC consumer antiseptic rub products. Their status will be addressed either after completion and analysis of the studies or at another time, if these studies are not completed. At this time, the FDA does not intend to take action to remove hand sanitizers containing these three active ingredients from the market.目前有三种活性成分（苯扎氯铵、乙醇和异丙醇）被延迟规定，因为需要继续进行研究，等待提交更多必要的安全有效性数据来确定他们是否安全有效，可用于OTC日用杀菌液产品。其状态将在完成研究分析后进行说明，或者如果研究仍未完成则在某个时间点进行说明。目前，FDA不会采取措施将含有这三种活性成分的手消毒剂撤市。Less than 3% of the marketplace will be affected by theissuance of this final rule, as most OTC consumer antiseptic rubs use ethylalcohol as the active ingredient.由于绝大多数OTC日用杀菌液使用乙醇作为活性成分，因此只有小于3%的市场会受此最终规定签发影响。The FDA is aware that retailers and pharmacies continueto market a very low number of consumer hand sanitizers containing benzethonium chloride, but that they stopped marketing hand sanitizers containing triclosan. Drug products containing any ineligible active ingredients will require approval under a new drug application or abbreviated new drug application prior to marketing.FDA了解零售商和药房会继续销售极少量含苄索氯铵的日用手消毒剂，但他们已停止销售含三氯羟基二苯醚（三氯生）的手消毒剂。含有任何不符合要求活性成分的药品将需要根据新药或简略新药申报程序获得批准方可上市销售。This final rule completes a series of rulemaking actionsin the FDA’s ongoing review of OTC antiseptic active ingredients to determine whether these ingredients are safe and effective for their intended uses. The FDA previously issued final rules on consumer antisepticwashes (Sept. 2016) and healthcare antiseptics (Dec. 2017).此次最终规定的发布完成了FDA持续审核OTC抗菌活性成分以确定这些成分的安全有效性是否满足其用途所做的一系列规章制订活动。FDA之前于2016年9月和2017年12月分别签发了日用抗菌洗剂和卫生抗菌剂最终规定。28种未通过审评活性成分（如需使用应按NDA或ANDA申报批准）2. Chlorhexidine gluconate 4 percentaqueous solution was also found to be ineligible for inclusion in the monographfor any healthcare antiseptic use and was not included in the 1994 TFM (59 FR 31402 at31413). We have not received any new information since the 1994 TFMdemonstrating that this active ingredient is eligible for the topicalantimicrobial monograph.4%的葡萄糖酸氯己定水溶液亦不符合任何卫生抗菌用途各论要求，未进入1994年TFM。自1994年TFM证明此活性成分不符合局部抗菌各论以来我们未收到任何新资料。3种待定活性成分（可按指定浓度直接用于OTC消毒剂） GRAS/GRAE=Generally Recognized asSafe/Generally Recognized as Effective.GRAS/GRAE=公认安全/公认有效日用杀菌手消毒剂提供了在没有普通香皂和水情况下简便的替代方法！学习了老师的分享！
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