篇名

新藥查驗登記採藥品臨床使用證據之探討   免費試閱

並列篇名

Using “Real World Evidence” for New Drug Application in Taiwan

作者
中文摘要

臺灣於藥品查驗登記之法規多半參考美國食品藥物管理局、歐洲藥品管理局及國際醫藥法規協合會作為標準。但伴隨美國通過「21世紀治療(治癒)法案」,並新增「利用藥品臨床使用證據」之規定,加速醫療產品之創新、減輕監管負擔、加強科學和方法研究的力度等議題因而紛紛浮現。本文針對已核准上市的藥品在進行新適應症、新複方查驗登記時,是否可採藥品臨床使用證據以支持藥品有效性及安全性,探討現行法規可修正之處。

英文摘要

Most of the new drug application regulation in Taiwan have followed the similar regulations as those of the US Food and Drug Administration (FDA), the European Medicine Agency (EMA), and the International Council for Harmonisation (ICH). With the passage of “Using Real- World Evidence (RWE)” in 21st Century Cures Act in US, we believe it will be a chance to improve the submission process for new drug application for existing drugs. In this study, we will focus on evaluating the potential of using RWE to support the approval of a new indication and drug combinations for existing approved drugs. At the end of this study, we will also discuss on how to revise the current “Regulations for Registration of Medicinal Products” as to support the evidence’s needs and speed up the process for the drug listing process.

起訖頁

007-021

出版單位
DOI

10.3966/241553062019090035001  複製DOI  DOI查詢

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