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首页> 外文期刊>International Journal of Pharmaceutics >Advancing pharmaceutical quality: An overview of science and research in the US FDA's Office of Pharmaceutical Quality
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Advancing pharmaceutical quality: An overview of science and research in the US FDA's Office of Pharmaceutical Quality

机译：提升药品质量：美国FDA药品质量办公室的科学研究概况

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摘要

Failures surrounding pharmaceutical quality, particularly with respect to product manufacturing issues and facility remediation, account for the majority of drug shortages and product recalls in the United States. Major scientific advancements pressure established regulatory paradigms, especially in the areas of biosimilars, precision medicine, combination products, emerging manufacturing technologies, and the use of real-world data. Pharmaceutical manufacturing is increasingly globalized, prompting the need for more efficient surveillance systems for monitoring product quality. Furthermore, increasing scrutiny and accelerated approval pathways provide a driving force to be even more efficient with limited regulatory resources. To address these regulatory challenges, the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) harbors a rigorous science and research program in core areas that support drug quality review, inspection, surveillance, standards, and policy development. Science and research is the foundation of risk-based quality assessment of new drugs, generic drugs, over-the-counter drugs, and biotechnology products including biosimilars. This is an overview of the science and research activities in OPQ that support the mission of ensuring that safe, effective, and high-quality drugs are available to the American public. Published by Elsevier B.V.
机译：药品质量方面的失败，特别是在产品制造问题和设施补救方面的失败，是造成美国药品短缺和产品召回的主要原因。重大的科学进步压力建立了监管范式，特别是在生物仿制药，精密医学，组合产品，新兴制造技术以及现实数据的使用领域。制药业日益全球化，促使人们需要更有效的监控系统来监控产品质量。此外，越来越多的审查和加速的批准途径为有限的监管资源提供了更加高效的动力。为了应对这些监管挑战，美国食品和药物管理局（FDA）药物评估与研究中心（CDER）的药物质量办公室（OPQ）在支持药物质量审查的核心领域内设有严格的科学和研究计划，检查，监视，标准和政策制定。科学和研究是对新药，非专利药，非处方药以及包括仿制药在内的生物技术产品进行基于风险的质量评估的基础。这是对OPQ中科学研究活动的概述，这些活动支持确保向美国公众提供安全，有效和高质量药物的使命。由Elsevier B.V.发布

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