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

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.