篇名

臺灣藥品早期臨床試驗──規範與現況   免費試閱

並列篇名

Regulations and Status of Early Clinical Trials of Medicinal Products in Taiwan

中文摘要

藥品研發與使用攸關國民健康與生命安全,受法規高度管制,試驗用藥物進行人體試驗,依風險而有不同程度的管理。早期臨床試驗的設計與高品質執行,係藥品後續大型樞紐性臨床試驗的關鍵,故其量能視為生醫產業發展的一項指標。限於市場及研發規模,臺灣早期臨床試驗量能仍有待提升。基於前瞻性考量,主管機關修訂相關行政指導和規範,期許產業界能投入更多資源於臺灣執行藥品早期臨床試驗,促進新藥開發和登記上市,嘉惠民眾健康福祉。

英文摘要

The development and use of medicinal products are strongly associated with the health and safety of citizens and demand rigorous regulation. Investigational new drugs must be regulated at different levels according to risks if they are to be used in clinical trials. The design and highquality conduction of early clinical trials is the key to the subsequent large-scale pivotal trials of investigational medicinal products and can be considered as an indicator to measure the biomedical innovation ecosystem. Limited by the scale of domestic market and the resources of research and development, the status of early clinical trials in Taiwan needs to be promoted. To facilitate the progress, the Taiwan Food and Drug Administration revised relevant guidelines and regulatory measures. It is expected that the industry will invest more resources in Taiwan to conduct early clinical trials and to develop new drugs, thereby benefiting the health and well-being of the public.

起訖頁

023-033

出版單位
DOI

10.3966/241553062020110049002  複製DOI  DOI查詢

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