Global Regulatory Affairs, Sanofi R&D, Chilly Mazarin, France.
Global Regulatory Affairs, Sanofi R&D, Chilly Mazarin, France.
Clin Ther. 2021 Jan;43(1):124-139. doi: 10.1016/j.clinthera.2020.11.015. Epub 2020 Nov 30.
PURPOSE: Crucial steps have been adopted by health and regulatory authorities around the world to respond to the COVID-19 pandemic. This review aims to highlight these steps by providing an overview of the regulatory approaches adopted during the onset of the pandemic, provide an assessment of observed trends, and offer some reflections and proposals to leverage learnings and opportunities from this current pandemic. METHODS: Documents and informational materials on regulating the development and management of medical products during the COVID-19 pandemic were collected and classified. These materials were sourced from official websites and press releases from health authorities and international bodies from selected markets across the globe, and covered the period between January and July 2020. Additional information to support this study was gathered through a literature review and analysis of related data available from the public domain, and was complemented with the authors' personal experience. FINDINGS: Communication has been vital in addressing the impact of COVID-19. A total of 1705 documents and informational materials related to health or regulatory response to the COVID-19 pandemic were gathered. Of these, 343 (around 20%) were identified as regulatory agilities. These agile approaches were classified into 3 categories, namely, where health and regulatory authorities had: (1) facilitated product management across the entire lifecycle, notably in expediting medical product use for COVID-19, ensuring the continuity of clinical trials, and addressing supply chain issues; (2) strengthened international cooperation; and (3) addressed regulatory burden with the adoption of electronic and digital tools. IMPLICATIONS: While many regulatory measures have been introduced temporarily as a response to the COVID-19 crisis, there are opportunities for leveraging an understanding from these approaches in order to collectively achieve more efficient regulatory systems and to mitigate and address the impact of COVID-19 and further future-proof the regulatory environment.
目的:全球卫生和监管机构已采取关键步骤来应对 COVID-19 大流行。本综述旨在通过概述大流行期间采用的监管方法,评估所观察到的趋势,并提供一些反思和建议,以利用当前大流行中的经验教训和机会,来突出这些步骤。
方法:收集和分类了有关在 COVID-19 大流行期间管理和开发医疗产品的监管方法的文件和信息材料。这些材料来源于全球选定市场的卫生当局和国际机构的官方网站和新闻稿,涵盖了 2020 年 1 月至 7 月期间的内容。为了支持本研究,还通过文献回顾和对公共领域可用的相关数据的分析收集了额外信息,并补充了作者的个人经验。
发现:沟通在应对 COVID-19 的影响方面至关重要。共收集了 1705 份与卫生或监管应对 COVID-19 大流行相关的文件和信息材料。其中,有 343 份(约 20%)被确定为监管敏捷性。这些敏捷方法分为三类,即卫生和监管当局:(1) 促进整个生命周期的产品管理,特别是加快 COVID-19 相关医疗产品的使用,确保临床试验的连续性,并解决供应链问题;(2) 加强国际合作;(3) 通过采用电子和数字工具来减轻监管负担。
意义:虽然许多监管措施是作为应对 COVID-19 危机的临时措施而引入的,但有机会利用这些方法的理解,以便共同实现更高效的监管系统,并减轻和应对 COVID-19 的影响,以及进一步为监管环境提供未来保障。
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