Department of Global Regulatory Affairs and Safety-CMC, Amgen Inc., Thousand Oaks, California 91320; University of Southern California, School of Pharmacy, Los Angeles, California 90089.
Department of Global Regulatory Affairs and Safety-CMC, Amgen Inc., Thousand Oaks, California 91320.
J Pharm Sci. 2020 Apr;109(4):1427-1438. doi: 10.1016/j.xphs.2020.01.020. Epub 2020 Jan 29.
The process of assembling regulatory documents for submission to multiple global health agencies can present a repetitive cycle of authoring, editing, and data verification, which increases in complexity as changes are made for approved products, particularly from a chemistry, manufacturing, and controls (CMC) perspective. Currently, pharmaceutical companies rely on a workflow that involves manual CMC change management across documents. Similarly, when regulators review submissions, they provide feedback and insight into regulatory decision making in a narrative format. As accelerated review pathways are increasingly used and pressure mounts to bring products to market quickly, innovative solutions for assembling, distributing, and reviewing regulatory information are being considered. Structured content management (SCM) solutions, in which data are collated into centrally organized content blocks for use across different documents, may aid in the efficient processing of data and create opportunities for automation and machine learning in its interpretation. The US Food and Drug Administration (FDA) has recently created initiatives that encourage application of SCM for CMC data, though many challenges could impede their success and efficiency. The goal is for industry and health authorities to collaborate in the development of SCM for CMC applications, to potentially streamline compilation of quality data in regulatory submissions.
将监管文件汇编提交给多个全球卫生机构的过程可能会呈现出一个重复的编写、编辑和数据验证周期，随着已批准产品的变化（特别是从化学、制造和控制（CMC）的角度来看），这个周期的复杂性会增加。目前，制药公司依赖于一种涉及跨文件手动 CMC 变更管理的工作流程。同样，当监管机构审查提交的文件时，他们会以叙述格式提供有关监管决策的反馈和见解。随着加速审查途径的日益使用以及尽快将产品推向市场的压力不断增加，正在考虑用于组装、分发和审查监管信息的创新解决方案。结构化内容管理 (SCM) 解决方案，即将数据整理到集中组织的内容块中，以便在不同的文档中使用，可能有助于高效处理数据，并为其解释创造自动化和机器学习的机会。美国食品和药物管理局 (FDA) 最近创建了鼓励应用 SCM 进行 CMC 数据的举措，尽管许多挑战可能会阻碍它们的成功和效率。目标是让行业和卫生当局共同开发 CMC 应用的 SCM，以潜在地简化监管提交中质量数据的汇编。
