FDA监管努力：确保防晒剂安全有效
出自识林
FDA监管努力：确保防晒剂安全有效
笔记 2015-11-24 FDA 引言 FDA药品审评与研究中心（CDER）非处方药产品处处长Theresa M. Michele医学博士，讨论了防晒剂使用模式转变和对尚未包含在OTC防晒剂专论中的防晒剂活性成分的额外安全性数据的需求。 防晒剂使用变化 防晒剂用于预防性治疗晒伤。当按照说明与其它防晒措施一起使用时，某些防晒剂还有助于降低皮肤癌和因日晒引起的皮肤过早老化风险。当防晒剂最早出现在市场上时，防晒剂偶尔在沙滩上使用，并经常用作晒黑的辅助用品。现在，许多不同的组织，包括皮肤科学会、公共卫生部部长办公室和FDA，鼓励所有年龄、种族和肤色的人们大量使用防晒剂，并当曝露在太阳下时经常反复使用。事实上，FDA和美国疾病控制和预防中心（CDC）建议消费者使用具有防晒系数（SPF）15或以上的广谱防晒剂，与其它防晒保护措施相结合，例如在日晒高峰时段寻找避光处、穿戴防晒衣物、帽子和太阳镜。 不断发展的科学知识 许多科学进步对防晒建议的巨大变化有影响。当然，主要发现是，太阳实际上会对皮肤造成辐射诱发的伤害。同样重要的是了解到，当按照说明与其它防晒措施共同使用时，那些提供广谱保护和SPF值为15或以上的防晒剂是预防皮肤癌的重要工具。此外，许多防晒剂配方方面的技术进步的出现，使得SPF值能够比15大得多，并且广谱防紫外线（UV-A和UV-B射线）强得多。但是，我们还发现，防晒剂活性成分可以通过皮肤被吸收，这是监管者评估防晒剂安全性时需要考虑的重要发现。 美国和国外对防晒剂的监管 因为防晒剂适用于帮助预防晒伤，某些防晒剂还适用于降低皮肤癌和因日晒引起的早期皮肤老化风险，所以防晒剂在美国作为药品监管。近些年，已经使用在欧洲国家销售的产品中的新防晒活性成分，如果没有已获批新药申请（NDA），不能合法的使用在美国销售的防晒剂产品中的情况引发了越来越多的关注。在欧洲，防晒剂作为化妆品监管，而非药品，并且这些国家对上市销售的要求不同。 FDA防晒剂监管现代化的工作 不断变化的防晒剂使用模式和不断发展的科学知识，促使FDA征求外部专家关于我们对防晒剂活性成分安全性评估的意见。2014年9月，我们举行了非处方药顾问委员会会议，召集来自该领域各方的医学和科学专家，以确定按照OTC防晒剂专论销售的防晒剂活性成分的安全测试类型和程度。在会议上，FDA代表解释指出，防晒剂应和任何其它长期施用于皮肤的非专利药一样看待，并制定拟议框架描述我们对于这些非处方防晒剂活性成分所要求的安全性数据。顾问委员会一致同意我们的拟议框架对于防晒剂成分来说是一个很好的起点。事实上，一些委员希望我们在要求更多数据方面走得更远一些。 防晒剂创新法案 顾问委员会会议结束不久之后，美国国会通过了防晒剂创新法案（SIA），为非处方防晒剂活性成分安全性和有效性的审评建立了新流程。SIA的一个误解是，SIA规定使用这些额外活性成分的防晒剂何时及多快能出现在市场上，而不需要NDA。SIA给了FDA关于安全性和有效性数据审评的非常具体的时间框架，但这些时间表在持有人递交必要数据之后才会触发。SIA也不会改变非处方防晒产品必须符合的安全性和有效性要求.我们仍必须坚持科学标准评估防晒产品的安全性和有效性。FDA必须依靠企业提供的充足的数据来做出积极的安全性和有效性决定。 新指南用于解决安全性数据空白 按照SIA的要求，FDA今天发布了4份关于非处方防晒剂活性成分的指南草案。最值得一提的指南说明了FDA对确定一个防晒活性成分是否被普遍认为是安全和有效所需的科学检测的当前考虑。所提出的研究并不是新的，与我们对长期使用的已获批外用药品的标准数据要求一致。 如指南草案中所述，我们推荐皮肤安全性研究已确定含有一定活性成分的产品是否会造成刺激或皮疹，或当曝露在阳光下时发生反应。因为根据SIA，防晒剂活性成分一定具备可供考虑的销售历史 – 通常在其它国家，我们还会审查现有的不良事件数据。此外，我们推荐能够获得在人体和动物体内药理学数据的研究，以评估如果有吸收的话，当施用于皮肤时，多少活性成分被吸收到体内。如果活性成分被吸收的量不超过指定量，我们在额外研究方面要求最低限度数据，例如观察对动物皮肤的影响。如果发现防晒剂活性成分被吸收，我们将要求额外的动物数据，包括活性成分一旦进入人体是否会引发癌症、生殖危害或内分泌影响。 一段时间以来，生产商必须检测每个OTC防晒产品（不管是根据OTC专论还是NDA销售）最终配方的有效性。例如，要求最终配方检测需确认每个最终产品提供承诺的SPF水平。根据指南草案中更加详细的说明，我们预计额外的安全性相关的最终配方检测，对于确保防晒产品的安全性不被活性成分和非活性成分的特定组合所破坏是必需的。我们欢迎对所有指南草案的评议，我们尤其鼓励公众对最终配方安全性检测的方法发表评议。 下一步 – 继续前进以确保防晒剂的安全性和有效性 FDA强烈建议消费者使用SPF值为15或更高的广谱防晒剂。这些产品应与其它防晒保护措施相结合，包括在日晒高峰时段避免阳光暴晒、寻找避光处、穿戴防晒衣物、帽子和太阳镜。 我们鼓励业界和公众对指南草案提供评议，特别是有关安全性和有效性的指南。在生产商审议指南的过程中，我们请他们从事研究工作，以解决自己的每种根据SIA正在评估的防晒剂活性成分的任何安全性数据空白。我们还鼓励申请人来与我们讨论，从而我们可以解决他们关于这些研究或指南可能存在的任何疑问。 我们认识到防晒剂在整个人群中的使用非常广泛，甚至在6个月大的儿童中使用。随着SIA的实施，FDA将继续与行业和公共健康利益攸关者合作，确保在所有不同人群中的消费者一生中每天使用的在自己和家人身上的防晒剂是安全有效的。感谢防晒剂的使用给公众健康带来的获益，我们致力于为美国消费者提供安全有效的防晒成分的多种选择。 翻译：识林-椒 From our perspective: Ensuring the safety and effectiveness of sunscreens Theresa M. Michele, M.D., Director of FDA's Center for Drug Evaluation and Research’s Division of Nonprescription Drug Products, discusses the changing pattern of sunscreen use and the need for additional safety data for sunscreen active ingredients that are not already included in the OTC sunscreen monograph. Changing use of sunscreens Sunscreens are a preventive treatment for sunburn. Certain sunscreens also help reduce the risk of skin cancer and premature skin aging caused by the sun when used as directed with other sun protection measures. When sunscreens first came on the market, they were used occasionally at the beach and often as tanning aids. Now, many different groups, including dermatology societies, the Surgeon General, and FDA, encourage people of all ages, ethnicities, and complexions to use sunscreens liberally and reapply frequently whenever they are out in the sun. In fact, FDA and CDC recommend that consumers use broad-spectrum sunscreens with a sun protection factor (SPF) of 15 or more in conjunction with other sun-protective measures like seeking shade at peak hours and wearing protective clothing, hats, and sunglasses. Evolving scientific knowledge A number of scientific advances were responsible for the dramatic changes in sunscreen recommendations. Of course, the major discovery is that the sun actually causes radiation-induced damage to the skin. No less important is the knowledge that certain sunscreens—those that provide broad spectrum protection and an SPF value of 15 or more—can be an important tool for skin cancer prevention, when used as directed with other sun protection measures. In addition, there have been a number of technological advances in the formulation of sunscreens, allowing SPFs greater than 15 and greater broad-spectrum protection against ultraviolet rays (UV-A and UV-B rays). We've also learned, however, that sunscreen active ingredients may be absorbed through the skin, a significant discovery that needs to be considered when regulators evaluate the safety of sunscreens. Sunscreen regulation in the United States and abroad Because sunscreens are indicated for use to help prevent sunburn, and some are also indicated for use to decrease the risks of skin cancer and early skin aging caused by the sun, they are regulated as drugs in the United States. In recent years, there has been a growing interest in new sunscreen active ingredients that have been used in products marketed in European countries but that cannot be legally included in sunscreens marketed in the United States without an approved new drug application (NDA). In Europe, sunscreens are regulated as cosmetics, not as drugs, and there are different requirements for marketing in these countries. FDA's work to modernize sunscreen regulation The changing pattern of sunscreen use and evolving scientific knowledge all prompted FDA to solicit input from external experts regarding our safety evaluation of sunscreen active ingredients. In September 2014, we held a meeting of the Nonprescription Drug Advisory Committee to bring together medical and scientific experts from all parts of the field to determine the type and extent of safety testing for sunscreen active ingredients to be marketed under the OTC sunscreen monograph. At the meeting, FDA representatives explained that sunscreens should be viewed like any other nonprescription drug chronically administered to the skin, and laid out a proposed framework to describe the safety data we require for these nonprescription sunscreen active ingredients. The advisory committee unanimously agreed that our proposed framework was a good starting point for sunscreen ingredients. In fact, some committee members wanted us to go even further in terms of requesting additional data. The Sunscreen Innovation Act Shortly after the advisory committee meeting, Congress passed the Sunscreen Innovation Act (SIA), creating a new process for the review of safety and effectiveness of nonprescription sunscreen active ingredients. A misperception of the SIA is that it dictates exactly when and how fast sunscreens using these additional active ingredients will be available on the market without an NDA. The SIA gives FDA very specific timeframes for review of safety and effectiveness data, but these timelines are not triggered until a sponsor submits the necessary data. The SIA also does not change the safety and effectiveness standard that nonprescription sunscreen products must meet. We still must adhere to the scientific standards for evaluating the safety and effectiveness of sunscreen products. FDA must rely on industry to provide adequate data to enable us to make positive safety and effectiveness determinations. New guidance to address safety data gaps As required by the SIA, today FDA is publishing four draft guidances pertaining to nonprescription sunscreen active ingredients. The most noteworthy guidance describes FDA’s current thinking on the scientific testing needed to determine whether a sunscreen active ingredient is generally recognized as safe and effective. The proposed studies are not novel and are consistent with our standard data requirements for approved topical drug products for chronic use. As outlined in the draft guidance, we are recommending skin safety studies to determine if products containing a certain active ingredient could cause irritation or rashes, or reactions when exposed to the sun. Because a sunscreen active ingredient must have a history of marketing—usually in other countries—to be considered under the SIA, we will also review available adverse event data. In addition, we are recommending studies to obtain pharmacology data in humans and animals to assess how much, if any, of the active ingredient is absorbed into the body when applied to skin. If the active ingredient is not absorbed above a specified amount, we ask for minimal data in terms of additional studies, such as looking at its effects on the skin of animals. If a sunscreen active ingredient is found to be absorbed, then we will ask for additional animal data including whether the active ingredient causes cancer, reproductive harm, or endocrine effects once it gets into the body. For some time now, manufacturers have had to test the final formulation of each OTC sunscreen product for effectiveness whether marketed under the monograph or an NDA. For example, final formulation testing is required to confirm that each final product provides the promised SPF level. As described in more detail in the draft guidance, we anticipate that additional safety-related final formulation testing will be necessary to ensure that the safety of a sunscreen product is not compromised by a particular combination of active and inactive ingredients. While we welcome comment on all of the draft guidances, we particularly encourage the public to comment on the approach to final formulation safety testing. Next steps – going forward to ensure safety and effectiveness of sunscreens FDA strongly recommends that consumers use broad-spectrum sunscreens with an SPF value of 15 or more. These products should be used in conjunction with other sun-protective measures, including staying out of the sun at peak times, seeking shade, and wearing protective clothing, hats, and sunglasses. We encourage industry and the public to provide us with comments on our draft guidances, particularly the guidance on safety and effectiveness. As manufacturers review this guidance, we ask that they work on studies to address any safety data gaps for each of their sunscreen active ingredients being evaluated under the SIA. We also encourage sponsors to come in and talk to us so that we can address any questions they may have regarding these studies or the guidances. We recognize that sunscreens are used very broadly by the whole population, even on children as young as 6 months of age. FDA will continue to work with industry and public health stakeholders as the SIA is implemented to ensure that the sunscreens consumers use on themselves and their families are safe and effective for daily use over a lifetime in all different populations. Recognizing the public health benefits of sunscreen use, we are committed to providing American consumers with additional options for safe and effective sunscreen ingredients. 适用岗位：
适用范围： 要点总结：
以上仅为部分要点，请阅读原文，深入理解监管要求。 |