An article entitled “Orphan drug development: The impact of regulatory and reimbursement frameworks” by Yu-Jun Huang, Wan-Yu Chao, Chi-Chuan Wang, Lin-Chau Chang is published in the journal, Drug Discovery Today, on 4 March 2022. The article discusses the regulatory and reimbursement frameworks in regions that enacted orphan drug-specific legislation, including the USA, the European Union, Australia, Japan, and Taiwan. The comparison of the frameworks, their impact on the numbers of orphan drug designations and approvals, and the challenges currently encountered could serve as valuable references for countries with comparable healthcare systems to take further measures regarding the implementation of orphan drug legislation. 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，黃郁鈞、趙婉妤、王繼娟、張琳巧，以“Orphan drug development: The impact of regulatory and reimbursement frameworks”為題之文章，已於2022年3月4日發表於Drug Discovery Today期刊。此研究討論已制定罕見疾病藥品相關法案之地區，其法規與保險給付之架構，包含美國、歐盟、澳洲、日本與臺灣法規與保險給付架構比較之結果、其對罕見疾病藥品認定與其中獲得上市許可藥品數量的影響、及當前所面臨之挑戰，可作為其他具相似體制國家於建制罕見疾病用藥相關法規上之重要參考。
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