Tran Russie, Fraser Grace, Fisher Adam C, Lee Sau L, Boam Ashley, Tsinontides Stelios, Maguire Jennifer, Yu Lawrence X, Rosencrance Susan, Kozlowski Steven, Henry Don
Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States of America.
Int J Pharm X. 2024 Mar 11;7:100239. doi: 10.1016/j.ijpx.2024.100239. eCollection 2024 Jun.
A network of regulatory innovations brings a holistic approach to improving the submission, assessment, and lifecycle management of pharmaceutical quality information in the U.S. This dedicated effort in the FDA's Center for Drug Evaluation and Research (CDER) aims to enhance the quality assessment of submissions for new drugs, generic drugs, and biological products including biosimilars. These regulatory innovations include developing or contributing: (i) the Knowledge-Aided Assessment and Structured Application (KASA), (ii) a new common technical document for quality (ICH M4Q(R2)), (iii) structured data on Pharmaceutical Quality/Chemistry, Manufacturing and Controls (PQ/CMC), (iv) Integrated Quality Assessment (IQA), (v) the Quality Surveillance Dashboard (QSD), and (vi) the Established Conditions tool from the ICH Q12 guideline. The innovations collectively drive CDER toward a more coordinated, effective, and efficient quality assessment. Improvements are made possible by structured regulatory submissions, a systems approach to quality risk management, and data-driven decisions based on science, risk, and effective knowledge management. The intended result is better availability of quality medicines for U.S. patients.
一个监管创新网络为改善美国药品质量信息的提交、评估和生命周期管理带来了整体方法。美国食品药品监督管理局药品评价和研究中心（CDER）的这项专门工作旨在提高新药、仿制药和生物制品（包括生物类似药）提交申请的质量评估。这些监管创新包括开发或贡献：（i）知识辅助评估和结构化申请（KASA），（ii）新的质量通用技术文档（ICH M4Q(R2)），（iii）药品质量/化学、制造和控制（PQ/CMC）的结构化数据，（iv）综合质量评估（IQA），（v）质量监督仪表板（QSD），以及（vi）ICH Q12指南中的既定条件工具。这些创新共同推动CDER朝着更协调、有效和高效的质量评估迈进。结构化的监管提交、质量风险管理的系统方法以及基于科学、风险和有效知识管理的数据驱动决策使改进成为可能。预期结果是为美国患者提供质量更好的药品。
