The Eu Is Ready For Non-Biological Complex Medicinal Products

GABI JOURNAL-GENERICS AND BIOSIMILARS INITIATIVE JOURNAL(2016)

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摘要
This paper describes the existing European Union legislation and scientific guidance to adequately assess the quality, safety and efficacy, as well as the lifecycle management, of the group of non-biological complex drug (NBCD) products, including nanomedicines such as liposomes, polymeric micelles, glatiramoids and iron-carbohydrate complexes.
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关键词
Complex pharmaceutical forms, EMA, nanomedicines, regulatory science
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