疫苗類藥品相關法規概述【本期企劃】 試閱
Introduction of Vaccine Regulation
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。
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.
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