对仿制药质量和疗效的一致性评价的多维思考和实践分析

Multidimensional reflection and practical analysis on the re-evaluation of the generic medicinal product

仿制药质量和疗效一致性评价的顺利开展,不仅需要解决微观层面的技术问题,更要从宏观层面予以重视。本文综合从药品的历史发展特征、品种广度特征以及质量和疗效特征等3个方面,进行了多方位的思考,对开展疗效评价和质量评价的关系进行了分析,有助于对具体品种进行研究和评价制定合理策略。

To rapidly carry out the work for re-evaluation of the generic medicinal product,it is not only necessary to resolve the technical problems at the microscopic level,but also to pay more attention at the macroscopic level. In this article,the multidimensional reflection is carried out mainly at following three aspects：the historical development characteristics,product breadth characteristics as well as the quality and efficacy characteristics. The relation between the conduct of quality and efficacy evaluation is analyzed,and it is expected to facilitate the establishment of reasonable strategy for the research and evaluation of specific product.