首页 > 资讯 > ANDA批准不再需要提交最终打印标签

出自识林

2015-10-12 Lachman CONSULTANTS

10月5日的联邦公报（FR）通告（请见此处）上，FDA表示，ANDA的批准将不再需要按照之前长期实施的那样提交最终打印标签（FPL）的实际或打印证明，OGD将接受用于批准目的的草案标签。对于提交FPL的要求甚至在1984年Hatch-Waxman修正案之前就存在了。

联邦公报公布《支持ANDA批准的草案标签的可接受性》最终行业指南。该变更将立即生效，无需经过草案阶段，因为这是一项将减轻企业监管负担的规定，并且与FDA对公众健康的关注相一致。仿制药企业仍可通过FR通知中的引用的卷宗提交评议。

FDA指出“鉴于随着时间推移在递交实践和法规适用性方面的变化，OGD正在阐明将在草案标签的基础上批准ANDA，只要OGD能够做出决定标签草案符合相关要求（除非是编辑的或类似的微小缺陷）。”读到这里，很显然草案标签应与FPL相当接近，而且不应有什么问题。

尽管之前的FDA指南（甚至最终规则）规定OGD不会批准没有FPL的ANDA，FDA指出“出于对相关法律和法规的进一步考虑，FDA已决定，只要草案标签唯一的缺陷是编辑性的或类似的微小缺陷，并且符合在新指南文件中列出的建议，可以基于草案标签批准ANDA。”

药品说明书和患者标签的草案标签是相当简单的。OGD之前的对FPL的批准前要求主要集中在容器和包装标签，以确保布局、字体、颜色和其它一般性格式条款不影响产品的安全性（例如，可读性、防止潜在用药错误）。OGD承认，目前现有的技术已经发展到允许审查草案标签代替FPL。因此，只要提交的草案标签足以解决这些类型的问题，OGD很乐意那么做。此外，这将改善潜在审批时间，因为FPL将不会是阻碍批准的最后一件事。新药方面通常基于草案标签批准NDA，并允许在批准后一定期限内递交FPL。现在ANDA和NDA将有着同等待遇。

Lachman CONSULTANTS - Bob Pollock先生
编译：识林-椒
识林^®www.shilinx.com版权所有，未经许可不得转载。如需使用请联系admin@shilinx.com

No More FPL Required for ANDA Approval
By Bob Pollock | October 5, 2015

In a Federal Register (FR) Notice today (here) , FDA has indicated that a long-held practice of requiring the submission of actual or printers proof of final printed labeling (FPL) will no longer be required for ANDA approval, and that OGD will accept draft labeling for approval purposes. The requirement for the submission of FPL has been around even prior to the Hatch-Waxman Amendments of 1984.

The FR notice announces the availability of the final Guidance for Industry Acceptability of Draft Labeling to Support ANDA Approval (here). The change will go into effect immediately without going through a draft stage because this is a provision that will reduce the regulatory burden on industry and is consistent with the public health focus of the Food and Drug Administration. Comments can still be submitted by the generic industry to the docket cited in the FR notice.

FDA notes that “[g]iven changes in submission practices and the applicable regulations over time, OGD is clarifying that it will approve ANDAs on the basis of draft labeling, provided that OGD is able to make a determination that the draft labeling complies with applicable requirements (other than editorial or similar minor deficiencies).” In reading this, it is clear that your draft labeling should be pretty close to your FPL and there should be no issues.

Even though previous Agency Guidance (and even a Final Rule) stated that OGD would not approve an ANDA without FPL, FDA states that “[u]pon further consideration of the relevant statutory and regulatory provisions, FDA has determined that an ANDA may be approved on the basis of draft labeling, provided that the only deficiencies in the draft labeling are of an editorial or similarly minor nature, and the draft labeling meets the recommendations” outlined in this new guidance document.

Draft labeling of the package insert and patient labeling is fairly straightforward. OGD’s prior preapproval requirement for FPL centered mostly on container and packaging labels to assure that layouts, fonts, colors, and other general formatting provisions did not impact the safety of the product (e.g., readability, prevent potential medication errors). OGD acknowledges that current available technology has evolved to permit this review of draft labeling in lieu of FPL. So as long as the draft labeling submitted is sufficient to address these types of issues, OGD is happy with that. In addition, this will improve potential approval times, as FPL will not be the last thing holding up approval. The New Drugs side of the house typically approves its NDAs based on draft labeling and permit submission of FPL within a certain period post-approval. Now ANDAs and NDA will be on the same footing.