再生醫療製劑之附附款許可制度——以日本藥機法為比較對象【本期企劃】 試閱
The Conditional and Termed Permit License Approval on Regenerative Medicine Preparations - In Comparison with the Japanese Act on Securing Quality, Efficacy, and Safety of Products Including Pharmaceuticals and Medical Devices
自行政院於2023年2月16日將「再生醫療法」及「再生醫療製劑條例」草案送交立法院審議後，隨即引發各界對「再生醫療法」草案之批判。最終導致兩法案均未能於本會期三讀通過。「再生醫療製劑條例」草案雖非輿論之焦點，但堪認為該草案特徵之「附附款許可制度」，是否完善，亦應受到重視。本文擬藉由比較日本法、行政院2022年版「再生醫療製劑管理條例」草案，以及上開「再生醫療製劑條例」草案之相關規定，評析目前草案之「附附款許可制度」所隱含的相關問題。
After the Executive Yuan submitted the drafts of the Regenerative Medicine Law and the “Regenerative Medicine Preparation Law” to the Legislative Yuan for review on February 16, 2023, it immediately triggered criticism from all sides regarding the draft of the Regenerative Medicine Law. This ultimately resulted in both bills failing to pass the legislation in this session. Although the draft of the Regenerative Medicine Preparation Law is not the focus of public opinion, whether the Conditional and Termed Permit License Approval, which can be regarded as a characteristic of such bill, is perfect should also be worth attention. This article intends to analyze the relevant issues implied by our country’s draft Conditional and Termed Permit License Approval by comparing applicable provisions of Japanese law, the Executive Yuan’s 2022 draft of the Regenerative Medicine Preparation Management Law, and the aforementioned Regenerative Medicine Preparation Regulations draft.
019-031
