Khalil Ramy, Macdonald Judith C, Gustafson Andrew, Aljuburi Lina, Bisordi Fabio, Beakes-Read Ginny
Scimitar Inc., Spokane, WA, United States.
Pfizer (United Kingdom), Tadworth, Surrey, United Kingdom.
Front Med (Lausanne). 2023 Jul 26;10:1233142. doi: 10.3389/fmed.2023.1233142. eCollection 2023.
Cloud-based regulatory platforms have the potential to substantially transform how regulatory submissions are developed, transmitted, and reviewed across the full life cycle of drug development. The benefits of cloud-based submission and review include accelerating critical therapies to patients in need globally and efficiency gains for both drug developers and regulators. The key challenge is turning the theoretical promise of cloud-based regulatory platforms into reality to further the application of technology in the regulatory processes. In this publication we outline regulatory policy journeys needed to effect the changes in the external environment that would allow for use of a cloud-based technology, discuss the prerequisites to successfully navigate the policy journeys, and elaborate on future possibilities when adoption of cloud-based regulatory technologies is achieved.
基于云的监管平台有潜力极大地改变药物开发生命周期中监管申报文件的制定、传输和审评方式。基于云的申报和审评的好处包括加快将关键疗法提供给全球有需要的患者，以及为药物开发者和监管机构提高效率。关键挑战在于将基于云的监管平台的理论前景变为现实，以推动技术在监管流程中的应用。在本出版物中，我们概述了实现外部环境变化以允许使用基于云的技术所需的监管政策历程，讨论了成功推进这些政策历程的先决条件，并阐述了采用基于云的监管技术后未来的可能性。
