篇名

疫苗類藥品相關法規概述   免費試閱

並列篇名

Introduction of Vaccine Regulation

作者
中文摘要

疫苗類藥品從研發到上市,是一個漫長且複雜之過程,包含前階段的研發探索、非臨床試驗、臨床試驗、查驗登記,以及上市後的安全監視等階段。為確保疫苗類產品之品質、安全及療效,各個階段均訂有法規,供研發者遵循,而且為與國際接軌,臺灣相關法規大致均參照國際規範所制定。本文將概要說明臺灣目前疫苗類藥品從研發到上市及上市後之相關法規與管理。

英文摘要

Development of vaccine is a long and complicated process, including research and exploratory stage, non-clinical trials stage, clinical trials stage, registration, and post-marketing safety surveillance. To ensure the quality, safety and efficacy of vaccine products, there are various regulations have been stipulated in Taiwan, for developers to follow. And those regulations are generally comparable with global standards. This article will outline the current vaccine regulations from pre-marketing to post-marketing status.

起訖頁

007-014

出版單位
DOI

10.3966/241553062018080022001  複製DOI  DOI查詢

QRCode

數位整合服務
產品服務
讀者服務專線:+886-2-23756688   傳真:+886-2-23318496   地址:臺北市館前路28號7樓

Copyright © 元照出版 All rights reserved. 版權所有,禁止轉貼節錄
TOP