Global Regulatory Science and Policy, Sanofi R&D, Chilly-Mazarin, France.
Global Regulatory Science and Policy, Sanofi R&D, Chilly-Mazarin, France.
Clin Ther. 2022 Mar;44(3):352-363. doi: 10.1016/j.clinthera.2022.01.001. Epub 2022 Jan 10.
Many regulators offered new ways of working to help combat the COVID-19 pandemic, and the rolling review procedure is an important and successful example. In rolling reviews, data are submitted and reviewed as they become available before the full data package is available. This approach is resource intensive but faster than standard review processes and therefore of benefit to society and patients during a health emergency. In this study, we analyze the European Medicines Agency (EMA) rolling review process and extract learning, based on the vaccines and treatments that have been approved to date (November 2021), and formulate 3 suggestions for the future.
Data and information on rolling reviews and similar related processes were collected from health authority websites across the globe with a focus on the EMA. Literature searches in PubMed and checking company websites for additional information were conducted to complement and corroborate findings as required.
The duration of a rolling review cycle and the number of cycles before a conditional marketing authorization differ among different applications. Through the rolling review process, COVID-19 vaccines could be approved in record times, ranging from 17 to 36 days. The rolling review process is not limited to vaccines but is applied to promising treatments as well.
This study indicates that rolling reviews can be successfully conducted during a health emergency, such as the COVID-19 pandemic, to meet an unmet medical need. Other critical conditions or life-threatening diseases with unmet needs exist and may be suitable to be addressed by a rolling review process to accelerate patient access to life-changing treatments. Indeed, we call for an evaluation of the rolling review process, its use, and its efficiency to capture learning with the aim of building a new, lean, and effective expedited review procedure that could be institutionalized and added to the regulatory toolbox.
许多监管机构提供了新的工作方式，以帮助应对 COVID-19 大流行，滚动审查程序就是一个重要且成功的范例。在滚动审查中，数据会在完整数据包可用之前，随着数据的不断提交和可用而进行审查。这种方法虽然资源密集，但比标准审查流程更快，因此在卫生紧急情况下对社会和患者有益。在这项研究中，我们分析了欧洲药品管理局（EMA）的滚动审查程序，并基于迄今为止（2021 年 11 月）批准的疫苗和治疗方法，总结了经验教训，并提出了 3 条未来建议。
通过全球各地的卫生当局网站收集了有关滚动审查和类似相关程序的数据和信息，重点是 EMA 的信息。在 PubMed 中进行文献检索，并检查公司网站以获取更多信息，以补充和证实研究结果。
滚动审查周期的持续时间和有条件上市许可前的周期数因不同的申请而异。通过滚动审查程序，COVID-19 疫苗可以在创纪录的时间内获得批准，时间从 17 天到 36 天不等。滚动审查程序不仅限于疫苗，也适用于有前景的治疗方法。
这项研究表明，在 COVID-19 大流行等卫生紧急情况下，可以成功进行滚动审查，以满足未满足的医疗需求。其他存在未满足需求的关键条件或危及生命的疾病可能适合通过滚动审查程序来加速患者获得改变生命的治疗方法。事实上，我们呼吁对滚动审查程序、其使用和效率进行评估，以总结经验教训，旨在建立一个新的、精简的、有效的加速审查程序，并将其纳入监管工具包。
