首页 > 资讯 > FDA更新初步儿科研究计划指南

出自识林

2016-03-10 Lachman CONSULTANTS

3月8日FDA发布《初步儿科研究计划和增补儿科研究计划的递交内容和流程》修订版指南草案。题目非常拗口，但如果你计划根据PREA（儿科研究公平法案）提交NDA，这一指南非常重要。如果拥有有效专利时同时获得6个月儿科专营权，企业当然希望获得在任何已有的专营权的基础上额外6个月的延长和额外6个月的保护期。

初步儿科研究计划（iPSP）指南文件解决了：

• 谁必须提交iPSP
• 何时必须提交iPSP
• iPSP中应包含什么
• 对已商定iPSP的增补请求中英包含什么
• 应用于iPSP提交的模板

指南草案推翻了PREA的历史，以及导致今天PREA下的要求的立法和监管措施（一些是失败的）。FDA通过注释概述了自2013年7月发布的首版指南草案以来的变更和更新：

该修订版包括对之前包含在2013年指南中章节的补充说明，以及新增章节，包括V.A节物料，VI节已商定iPSP与随申请提交儿科计划的要求的关系，VII节对初步PSP的增补请求的内容和时机，VIII节未商定初步儿科研究计划，和IX节对未商定初步儿科研究计划达成协议。此外附录初步儿科研究计划模板已更新。

指南进一步规定了iPSP提交的时机，以及以合理和真诚的态度处理儿科计划的重要性。FDA还警告指出，申请人“在iPSP达成协议之前，不应提交上市申请或补充申请。”这当然可能包括延期请求或对要求的豁免。但尽管如此，FDA坚持，如果提交属于PREA，必须在任何NDA（原始或补充）提交之前处理iPSP。指南还解决了与内容和格式相关的问题，以及提交的各种时机和FDA审评对申办人的反馈，更多细节请仔细阅读指南，尤其是如果你的产品可能属于PREA的规定下。

Lachman CONSULTANTS - Bob Pollock先生
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Pediatric Study Plan Guidance Updated by FDA
By Bob Pollock | March 8, 2016

Today, FDA issued a revised draft Guidance document entitled, Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans. Quite a mouthful, but exceedingly important if you plan on submitting an NDA that is subject to PREA (Pediatric Research Equity Act). Firms (of course) want to gain an additional 6-month extension on any existing exclusivity and have another 6-month period of protection, if there is a valid in force patent at the time of award of any period of 6-month pediatric exclusivity.

The Initial Pediatric Study Plan (iPSP) Guidance document addresses:

• Who must submit an iPSP
• When an iPSP must be submitted
• What should be included in an iPSP
• What should be included in a requested amendment to an agreed iPSP
• A template that should be used for an iPSP submission

The document runs down the history of the PREA and the legislative and regulatory initiatives (some failed) that led to today’s requirements under PREA. The Agency outlines the changes and updates that have been made since the first draft Guidance issued in July 2013 by noting:

This revision includes additional clarifications regarding sections previously included in the 2013 guidance as well as new sections that have been added, including: section V.A., Materially Incomplete iPSPs, section VI., Relationship of Agreed iPSP to the Requirement to Submit a Pediatric Plan With an Application, section VII., Contents and Timing of Requested Amendment to an Initial PSP, section VIII., Non-Agreed Initial Pediatric Study Plans, and section IX., Reaching Agreement on the Non-Agreed Initial Pediatric Study Plan. Additionally, Appendix 1, Initial Pediatric Study Plan Template, has been updated.

The Guidance further outlines timing of submission of the iPSP and the importance of addressing the pediatric plan in a rational and sincere manner. FDA also cautions that an applicant “should not submit a marketing application or supplement until agreement has been reached on the iPSP.” This, of course, could include a deferral request or waiver of the requirements. But, none the less. FDA maintains that the iPSP must be addressed ahead of any NDA (original or supplements) filing if the filing falls under PREA. Issues associated with the content and format, as well as various timing for submission and FDA review with feedback to the sponsor are also addressed, but in more detail than we chose to cover in this post. Please see and read the Guidance carefully if your product may fall under the provisions of PREA, so there are no surprises during the submission and review process. The full content of the draft Guidance can be found here.