口服固体仿制制剂质量和疗效持续一致性的技术考量

Technical Considerations for Continuous Consistency in the Quality and Efficacy of Oral Solid Generic Formulations

摘要

仿制药质量和疗效一致性评价包括临床试验/申报批次与原研制剂质量和疗效一致性的评价（第一个一致性），以及仿制药商业化生产批次与临床试验/申报批次持续一致性的评价（第二个一致性）。从产品开发、控制策略建立、个药指导原则完善、上市后变更管理等几个方面探讨如何实现第二个一致性，避免仿制药“一致性评价”变为“一次性评价”，确保一致性评价成果得以持续和扩大。

Abstract

The equivalency evaluation of quality and efficacy for generic drugs encompasses two aspects: (1) the evaluation of equivalency between the clinical trial/submission batches and the reference listed drug (the first consistency), and (2) the evaluation of continuous consistency between commercial batches and the clinical trial/submission batches (the second consistency). This article discusses how to achieve the second consistency, focusing on product development, establishment of control strategies, refinement of product-specific guidelines, and management of post-approval changes. These considerations aim to prevent the transformation of generic drug "equivalency evaluation" into a "one-time evaluation", thereby ensuring that the outcomes of equivalency evaluation are maintained and expanded.

关键词

质量和疗效一致性评价 / 仿制药 / 持续一致性 / 质量源于设计 / 个药指导原则 / 上市后变更

Key words

quality and efficacy equivalency evaluation / generic drug / continuous consistency / quality by design / product specific guidance / post-approval change

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