https://scholars.lib.ntu.edu.tw/handle/123456789/634507
標題: | Orphan drug development: The impact of regulatory and reimbursement frameworks | 作者: | Huang, Yu-Jun Chao, Wan-Yu CHI-CHUAN WANG LIN-CHAU CHANG |
關鍵字: | Orphan drugs; Rare diseases; Regulatory framework; Reimbursement | 公開日期: | 六月-2022 | 卷: | 27 | 期: | 6 | 起(迄)頁: | 1724 | 來源出版物: | Drug discovery today | 摘要: | The enactment of orphan drug-specific legislation pioneered by the USA was subsequently followed by many regions, including the European Union (EU), Australia, Japan, and Taiwan. Here, we discuss the associated regulations established and their impacts in the aforementioned regions, which are among the first with frameworks specific for orphan drugs. Varied scopes of rare diseases or orphan drugs, diverse incentives, and heterogeneous types of reimbursement systems imply the prioritization of the agencies concerned. The numbers of designated and approved drugs reflect the impact of the regulatory and reimbursement frameworks. A comparison of the frameworks and their impact in the respective regions could provide valuable information for developing and improving related frameworks for countries worldwide. |
URI: | https://scholars.lib.ntu.edu.tw/handle/123456789/634507 | ISSN: | 13596446 | DOI: | 10.1016/j.drudis.2022.03.002 |
顯示於: | 藥學系 |
在 IR 系統中的文件,除了特別指名其著作權條款之外,均受到著作權保護,並且保留所有的權利。