An article entitled “Regulatory considerations for generic products of non-biological complex drugs” by Yu-Hsuan Liu, Yi-Shuo Chen, Ting Tseng, Min-Lin Jiang, Churn-Shiouh Gau, and Lin-Chau Chang, is published in the journal, Journal of Food and Drug Analysis, on 15 March 2023. This article compares EU and US requirements for developing generic non-biological complex drugs (NBCDs), such as nab-paclitaxel injections and liposomal injections. Pharmaceutical comparability through comprehensive characterization is essential, but approval pathways and requirements may differ. Harmonization of regulations is expected through the pilot program established by the European Medicines Agency (EMA) and Food and Drug Administration (FDA), facilitating NBCD follow-on versions. Authors are grateful for the support from the National Taiwan University School of Pharmacy Endowment Fund in support of the Platform for Research and Inspiration in Regulatory Science.
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感謝「臺大藥學發展永續基金計畫」對於國際藥政法規科學研究平台之支持，劉于萱、陳怡碩、曾婷、江旻霖、高純琇、張琳巧，以“Regulatory considerations for generic products of non-biological complex drugs”為題之文章，已於2023年3月15日發表於Journal of Food and Drug Analysis期刊。此研究比較歐盟和美國在非生物複雜藥物 (NBCD) 於審查要求上的差異，其中包括奈米載體紫杉醇注射劑和微脂粒注射劑等藥物。研究指出，透過詳細結構及特徵鑑定來證明藥劑相似性是非常重要的，然而在審查途徑和法規要求面上可能仍存有差異。歐洲醫藥管理局 (European Medicines Agency, EMA) 和美國食品藥品管理局 (Food and Drug Administration, FDA) 共同合作的先導計畫 (pilot program)，有望實現法規審查要求的一致性，進而促進NBCD的學名藥開發。
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