Krogulski Sandra
1 Accenture, Berwyn, PA, USA.
Ther Innov Regul Sci. 2017 Sep;51(5):645-650. doi: 10.1177/2168479017702185. Epub 2017 Apr 13.
June 2016 marks 1 full year since the optional implementation of US Module 1 Specification v2.3. Since its release, pharma companies have dealt with expanded submission-level metadata fields, the ability to submit advertising and promotional submissions, and more rigid validation criteria. Prior to transitioning, sponsors must ensure their building and validating tools are up-to-date, that a system is in place to integrate departments working together for the first time, and that all guidance documents are understood and implemented. Sponsors now can group submissions across application types, which will help save rework across submissions. Looking at one submission type now accepted in eCTD, this paper will explore the new functionality that has created new possibilities and challenges for Regulatory Operations.
2016年6月标志着美国模块1规范v2.3可选实施已满一整年。自发布以来，制药公司一直在应对提交层面元数据字段的扩展、提交广告和促销材料的能力以及更严格的验证标准。在过渡之前，申办者必须确保其构建和验证工具是最新的，要有一个系统来整合首次协同工作的各个部门，并且所有指导文件都得到理解和实施。申办者现在可以对不同申请类型的提交材料进行分组，这将有助于减少提交材料的返工。本文将着眼于目前eCTD中接受的一种提交类型，探讨为法规运营带来新可能性和挑战的新功能。
