FDA发布OTC历时及覆盖范围申请（TEA）拟议规定
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FDA发布OTC历时及覆盖范围申请（TEA）拟议规定
笔记 2016-04-07 Lachman CONSULTANTS 4月4日FDA发布关于非处方药（OTC）历时及覆盖范围申请（TEA，Time and Extent Applications）的拟议规定 新的拟议规定是实施2014防晒剂创新法案（SIA）的一部分（新的拟议规定排除了防晒产品，是因为有其它规定针对这些产品）。“联邦食品药品和化妆品法案（FD&CA）586F(b)部分明确要求FDA发布规定，为按照TEA规定的递交提供及时和有效的审评，包括(1)为此类非防晒剂OTC活性成分或其它条款（condition，条款是指上市销售的具体非处方药使用的活性成分或植物药成分（或两者的组合）、剂型、剂量或给药途径。）（非防晒剂TEA条款）的提交建立审评和行动的合理时间线，(2)跟踪满足此类时间线程度的可测量的量度指标。”“FDA还拟议修改TEA规定，通过增加递交确认要求和标准以及通过解决TEA考量的撤销和数据递交的安全性和有效性，使TEA流程对于产品申办人和FDA更加高效和具有可预测性。”此外，FDA拟议增加一条很像ANDA和NDA“递交确认”的条款，FDA对TEA开展初步评估确认TEA是否包含充分的信息可以让FDA进行实质性的科学审评。 拟议规定继续讨论了OTC流程的历史和现在的TEA流程。拟议时间限和量度指标只有两个例外：第一个是任何涉及防晒剂的成分和条款，第二个是如果产品在SIA颁布日期之前通过TEA递交。这里有一些FDA模棱两可的措辞 – “不过，如SIA中规定，在SIA颁布日期之前被确定符合被考虑列入OTC药品专论系统的任何非防晒剂TEA条款，在申办人没有按照586F(A)(1)请求审评框架的情形下，也将按照该拟议规定§330.15(c)规定的时间线审评（见FD&CA 586F(a)(1)(C)）（如果按照拟议定稿的话）。”或许可以有人能够搞清楚这句话在说什么。 拟议时间线包括：
注意，在申办人确认在TEA中提供完整的安全性和有效性数据包之前（此类声明必须在递交时出现在TEA中），90天的递交确认将不会开始。 如果FDA认定条款或成分是不认为安全有效的（GRASE, Generally recognized as safe and effctive），那么他们将在730天（24个月）内发布确认和通知申办人. 如果确定是有利的，将在现有专论中包含新的条款或成分，或建立新的专论，或作出决定在上市之前必须在根据FD&CA 505的申请中提交新条款或成分 – 此类决定一般在36个月之内在拟议规定中做出。 FDA一般将在30个月内发布最终规定，这将为评议和FDA对拟议规定评估和形成一件提供充足的时间。 该拟议规定继续解释了FDA是如何基于公众健康需求、FDA可用资源和公众健康利益影响得出的时间框架。此外，该拟议规定列出了FDA在建立时间线时考虑的问题。 量度指标包括：
虽然时间线和量度指标还没有真正使用，但对FDA来说是一件大事。虽然时间线相对较长，尤其是如果FDA需要进入拟议和最终规定阶段，至少企业将明白采取这一路线的时间考量。请记住，对于首次上市的OTC产品，企业总是可以递交拥有PDUFA目标日期的505(b)申请，但由于PDUFA付费成本和可能存在潜在的额外数据要求，企业倾向于回避这一途径。 Lachman CONSULTANTS - Bob Pollock先生 TEA Anyone? The FDA has published a proposed rule regarding Time and Extent Applications (TEAs) that will establish timelines and metrics associated with their review. Just to remind you, a TEA is now the preferred option to add a product to an over-the-counter (OTC) monograph for products that were initially marketed in the United States after the OTC review began in 1972 and for products with no US marketed experience. This new proposed rule implements sections of the Sunscreen Innovation Act (SIA) of 2014 (albeit it excludes sunscreen products, that is because there are other provisions that address such products). “Section 586F(b) of the FD&C Act specifically requires FDA to issue regulations providing for the timely and efficient review of submissions under the TEA regulation, including establishing (1) reasonable timelines for reviewing and acting on such submissions for nonsunscreen OTC active ingredients and other conditions (non-sunscreen TEA conditions) and (2) measurable metrics for tracking the extent to which such timelines are met.” “FDA is also proposing to amend the TEA regulation to make the TEA process more efficient and predictable for both product sponsors and FDA by adding filing determination requirements and criteria and by addressing the withdrawal of consideration of TEA and safety and effectiveness data submissions.” In addition, FDA is proposing to add a provision much like a “filing determination” for ANDAs and NDAs where the Agency performs an initial assessment as to whether the TEA contains sufficient information for the FDA to undertake a substantive scientific review. The proposed rule goes on to discuss the history of the OTC process and the current TEA process. The proposed timelines and metrics are applicable to FDA and have only two exceptions; the first is for any ingredient or condition related to sunscreens (explained above) and the second is if the product was subject to a TEA submitted prior to the date of enactment of the SIA. And now for some FDA weasel words – “However, as provided in the SIA, any non-sunscreen TEA conditions determined to be eligible to be considered for inclusion in the OTC drug monograph system before the date of enactment of the SIA, for which the sponsor did not request a framework for review under section 586F(a)(1), will also be reviewed under the timelines set forth in §330.15(c) of this proposed rule (see FD&C Act section 586F(a)(1)(C)) (if finalized as proposed).” Maybe someone can help me figure this one out (read the proposed rule for more clarity here). The proposed timelines are:
Note the 90-day filing determination will not begin until the sponsor confirms that a complete safety and efficacy data package are presented in the TEA (such statement must appear in the TEA at time of submission). If FDA decides that the condition or ingredient is not GRASE, then they will issue a determination and notify the sponsor in 730 days (24 months) If the determination is favorable and will include the new condition or ingredient in an existing monograph, or establish a new monograph, or make a determination that the new condition or ingredient must be submitted in an application under 505 of the Act before marketing – such decision will be made in a proposed rule and generally within 36 months. FDA will issue a final rule within generally 30 months which will provide sufficient time for comments and FDA evaluation and formation of opinion on the proposed rule. The rule goes on to explain how FDA arrived at the timeframes based on public health needs, available Agency resources, and the impact of public health interests. In addition, the proposed rule addresses the issues FDA considered in establishing the timelines. Metrics include:
This is a big deal for FDA as timeline and metrics have not really been employed. While the timelines are relatively long, especially if FDA needs to get to the proposed and final rule stages, at least industry will understand the time consideration for taking this route. Remember a firm can always file a 505(b) application for first time marketing of an OTC product with PDUFA goal dates, but firms have tended to shy away from this avenue due to the cost on PDUFA fees and the potential additional data requirements that may exist. Happy reading – but be certain you have some cookies and plenty of sugar when considering your TEA. 适用岗位：
适用范围： 文件要点总结：
以上仅为部分要点，请阅读原文，深入理解监管要求。 |
，将建立与审评相关的时间线和绩效量度指标。TEA是21 CFR 330.14规定的，是让具有足够上市时间（time）和足够广泛的覆盖范围（extent）的药品纳入