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00:00:42,098\n今天討論的主題是美國實施進口產品的國安調查對我國產業界的影響跟因應之道根據經濟部的資料顯示美國已經完成了國安調查包括鋼鋁汽車還有半導體跟藥品等等重點應該是說台灣\n\n3\n00:00:44,400 --> 00:00:52,293\n對的出口是否對美發生逆差或是有國安的影響嗎對不對但是今天看到是貴屬的報告當中是以美國的藥品醫療器材對台灣出口的影響作為因應措施請問為什麼重點是放在\n\n4\n00:00:59,700 --> 00:01:16,993\n跟委員報告就是因為經過我們了解事實上我們國內的藥廠出口到美國它的跟相對於美國出口到台灣它是相對我們是以進口為主那剛剛有簡單報告以去年的調查為例那我國藥廠出口到美國的金額大約是3億美元\n\n5\n00:01:17,793 --> 00:01:28,799\n佔我們國家藥品出口的比例大概到37%但是我們從美國進口的藥品的金額大概達到5億美元大概佔我們所有輸入藥品的金額的10%\n\n6\n00:01:33,342 --> 00:01:57,681\n可是從經濟部的報告卻顯示說美國為台灣藥品的出口最大市場那生技藥品的出口達到出口有達到10億美元這事實上是有差異的那我希望的是說經濟部跟衛福部這邊能夠做一個這個業務上面的一個協調在這邊尤其是未來要準備的是要做出口的這樣子的市場的一個開拓的時候就是非常重要的那我想要請問一下就這個10億美元的\n\n7\n00:01:59,742 --> 00:02:16,946\n生技跟醫藥出口當中是以醫藥醫用藥材跟西藥製造業跟學名藥原料藥跟疫苗試劑等為最大類別請問一下880億的行政院的預算當中衛福部這邊分到多少在食藥署這邊跟委員報告目前我們還在爭取中還在爭取中還在跟行政院這邊爭取跟協調\n\n8\n00:02:21,618 --> 00:02:37,176\n好那再請問一下因為美國既然是我們可以出口的市場當中應該有相當的競爭力也許有像那我們如果說是開拓市場的話事實上有沒有這樣子的開拓到把這樣子現在目前我們對美的輸出把它分證到其他市場的一個需求報告委員我們正在積極的輔導我們相關的藥廠業者可以朝譬如說歐洲的國家\n\n9\n00:02:41,401 --> 00:03:02,590\n因為目前食藥署也是加入很多國際組織所以我們在藥廠的GMP規範上以及我們的管理法規上都跟歐盟是一致那我們在109年也取得歐洲原料藥的第三國清單所以國內的原料藥如果要輸入到歐洲的話是不需要再經過歐洲的茶廠所以這個部分我們會鼓勵國內的藥廠盡量朝歐洲的方向發展好那這邊我請教應該是經濟部裡面的國際貿易署因為署長\n\n10\n00:03:11,901 --> 00:03:31,210\n好劉署長您好委員好這個部分因為上週有經濟部的官員來拜訪的時候特別提到說因為上週前幾週的時候郭部長有回應到說我們不管在所謂的產業上面的這樣的多元市場的部分就是以歐盟跟印度還有土耳其為最主要的一個開拓市場這些部分那可是上週的這個來\n\n11\n00:03:32,791 --> 00:04:00,336\n拜訪的時候有官員就提到是說我們這個對歐盟的地方事實上開拓的有困難等等因為很多國家可是事實上歐盟在1995年的時候就形成一個單一市場了這部分進來經濟部裡面的官員裡面還有提到說歐盟還是必須要很多國家去合約談這樣的情況之下你怎麼回應呢如果你剛才也提到說醫藥這邊也是要把快拓到市場到歐盟去的時候那請問你怎麼回應你們怎麼去看待歐盟的市場\n\n12\n00:04:02,498 --> 00:04:32,081\n报告委员欧盟的确它是一个单一的市场那在医药的部分因为其实欧盟其实它有一些管理性的规定那我们针对那些管理性的规定我们基本上都会跟业者来进行一些说明它常常有些那些规定然后我们主要是让业者知道那些的规定是什么因为进入市场在药品跟其他的产品有一个很大的不一样你要进去那个市场要经过它的主管金官的认可才能够进去所以这个部分是非常重要的\n\n13\n00:04:32,521 --> 00:04:56,481\n所以說是醫藥這邊因為跟人體身體健康是有關係所以他有特別的一個程序上面是這樣子好這樣了解了好那另外一部分還有就是在於核心關鍵國家核心關鍵技術在半導體這一部分很重要的是昨天我們當齊凱委員在辦這個公聽會的時候也知道的是說目前在這個關鍵核心技術的這個審查地是在所謂的投資審查署嗎是嗎\n\n14\n00:04:59,063 --> 00:05:15,584\n投資投審司在投審司這部分那這邊我們都已經知道了是威澤家他已經在公開在上個月這個月都已經講到是我們未來的話就是一定要到美國去投資這部分可是這邊的投審司已經講到的是目前\n\n15\n00:05:16,525 --> 00:05:34,113\n台積電還沒有提出的審查報告還沒有提出審查申請案這部分那未來的情況之下如果投審會投審師如果決定如果發現它裡面涉及到我們核心關鍵技術尤其是在高階的部分在研發IC設計設計這部分的時候那難道我們國家會我們的投審師會說NO嗎或是整個這個部分請回答\n\n16\n00:05:39,475 --> 00:06:08,036\n跟委員報告就是未來投審是這邊如果收到台積電的申請因為我們投審會是一個審查平台所以我們會送審除了包括我們自己的產發署之外還包括國科會等等的技術主管機關那我們會尊重技術主管機關的意見好所以有可能就是到時候台積電就不會去美國嗎是有可能的就是說就是尊重這個國科會上面主管機關的部分在科技上面的審查\n\n17\n00:06:08,979 --> 00:06:19,198\n是有可能嗎這個就是要看那個技術主管機關審查的結果好那事實上是可能是有可能的因為在還沒有結果審查出來之前的話Yes跟No都有可能嘛好就這樣子謝謝\n\n","tsv":"start\tend\ttext\n9758\t16149\t有請衛福部食品藥物署管理署副署長王德元先生好請衛福部副署長\n22471\t42098\t今天討論的主題是美國實施進口產品的國安調查對我國產業界的影響跟因應之道根據經濟部的資料顯示美國已經完成了國安調查包括鋼鋁 汽車還有半導體跟藥品等等重點應該是說台灣\n44400\t52293\t對的出口是否對美發生逆差或是有國安的影響嗎對不對但是今天看到是貴屬的報告當中是以美國的藥品醫療器材對台灣出口的影響作為因應措施請問為什麼重點是放在\n59700\t76993\t跟委員報告就是因為經過我們了解事實上我們國內的藥廠出口到美國它的跟相對於美國出口到台灣它是相對我們是以進口為主那剛剛有簡單報告以去年的調查為例那我國藥廠出口到美國的金額大約是3億美元\n77793\t88799\t佔我們國家藥品出口的比例大概到37%但是我們從美國進口的藥品的金額大概達到5億美元大概佔我們所有輸入藥品的金額的10%\n93342\t117681\t可是從經濟部的報告卻顯示說美國為台灣藥品的出口最大市場那生技藥品的出口達到出口有達到10億美元這事實上是有差異的那我希望的是說經濟部跟衛福部這邊能夠做一個這個業務上面的一個協調在這邊尤其是未來要準備的是要做出口的這樣子的市場的一個開拓的時候就是非常重要的那我想要請問一下就這個10億美元的\n119742\t136946\t生技跟醫藥出口當中是以醫藥醫用藥材跟西藥製造業跟學名藥原料藥跟疫苗試劑等為最大類別請問一下880億的行政院的預算當中衛福部這邊分到多少在食藥署這邊跟委員報告目前我們還在爭取中還在爭取中還在跟行政院這邊爭取跟協調\n141618\t157176\t好那再請問一下因為美國既然是我們可以出口的市場當中應該有相當的競爭力也許有像那我們如果說是開拓市場的話事實上有沒有這樣子的開拓到把這樣子現在目前我們對美的輸出把它分證到其他市場的一個需求報告委員我們正在積極的輔導我們相關的藥廠業者可以朝譬如說歐洲的國家\n161401\t182590\t因為目前食藥署也是加入很多國際組織所以我們在藥廠的GMP規範上以及我們的管理法規上都跟歐盟是一致那我們在109年也取得歐洲原料藥的第三國清單所以國內的原料藥如果要輸入到歐洲的話是不需要再經過歐洲的茶廠所以這個部分我們會鼓勵國內的藥廠盡量朝歐洲的方向發展好 那這邊我請教應該是經濟部裡面的國際貿易署因為署長\n191901\t211210\t好 劉署長您好委員好這個部分因為上週有經濟部的官員來拜訪的時候特別提到說因為上週前幾週的時候郭部長有回應到說我們不管在所謂的產業上面的這樣的多元市場的部分就是以歐盟跟印度還有土耳其為最主要的一個開拓市場這些部分那可是上週的這個來\n212791\t240336\t拜訪的時候有官員就提到是說我們這個對歐盟的地方事實上開拓的有困難等等因為很多國家可是事實上歐盟在1995年的時候就形成一個單一市場了這部分進來經濟部裡面的官員裡面還有提到說歐盟還是必須要很多國家去合約談這樣的情況之下你怎麼回應呢如果你剛才也提到說醫藥這邊也是要把快拓到市場到歐盟去的時候那請問你怎麼回應你們怎麼去看待歐盟的市場\n242498\t272081\t报告委员欧盟的确它是一个单一的市场那在医药的部分因为其实欧盟其实它有一些管理性的规定那我们针对那些管理性的规定我们基本上都会跟业者来进行一些说明它常常有些那些规定然后我们主要是让业者知道那些的规定是什么因为进入市场在药品跟其他的产品有一个很大的不一样你要进去那个市场要经过它的主管金官的认可才能够进去所以这个部分是非常重要的\n272521\t296481\t所以說是醫藥這邊因為跟人體身體健康是有關係所以他有特別的一個程序上面是這樣子好這樣了解了好那另外一部分還有就是在於核心關鍵國家核心關鍵技術在半導體這一部分很重要的是昨天我們當齊凱委員在辦這個公聽會的時候也知道的是說目前在這個關鍵核心技術的這個審查地是在所謂的投資審查署嗎是嗎\n299063\t315584\t投資投審司在投審司這部分那這邊我們都已經知道了是威澤家他已經在公開在上個月這個月都已經講到是我們未來的話就是一定要到美國去投資這部分可是這邊的投審司已經講到的是目前\n316525\t334113\t台積電還沒有提出的審查報告還沒有提出審查申請案這部分那未來的情況之下如果投審會投審師如果決定如果發現它裡面涉及到我們核心關鍵技術尤其是在高階的部分在研發IC設計設計這部分的時候那難道我們國家會我們的投審師會說NO嗎或是整個這個部分請回答\n339475\t368036\t跟委員報告就是未來投審是這邊如果收到台積電的申請因為我們投審會是一個審查平台所以我們會送審除了包括我們自己的產發署之外還包括國科會等等的技術主管機關那我們會尊重技術主管機關的意見好 所以有可能就是到時候台積電就不會去美國嗎是有可能的就是說就是尊重這個國科會上面主管機關的部分在科技上面的審查\n368979\t379198\t是有可能嗎這個就是要看那個技術主管機關審查的結果好 那事實上是可能是有可能的因為在還沒有結果審查出來之前的話Yes跟No都有可能嘛好 就這樣子 謝謝\n","txt":"有請衛福部食品藥物署管理署副署長王德元先生好請衛福部副署長\n今天討論的主題是美國實施進口產品的國安調查對我國產業界的影響跟因應之道根據經濟部的資料顯示美國已經完成了國安調查包括鋼鋁 汽車還有半導體跟藥品等等重點應該是說台灣\n對的出口是否對美發生逆差或是有國安的影響嗎對不對但是今天看到是貴屬的報告當中是以美國的藥品醫療器材對台灣出口的影響作為因應措施請問為什麼重點是放在\n跟委員報告就是因為經過我們了解事實上我們國內的藥廠出口到美國它的跟相對於美國出口到台灣它是相對我們是以進口為主那剛剛有簡單報告以去年的調查為例那我國藥廠出口到美國的金額大約是3億美元\n佔我們國家藥品出口的比例大概到37%但是我們從美國進口的藥品的金額大概達到5億美元大概佔我們所有輸入藥品的金額的10%\n可是從經濟部的報告卻顯示說美國為台灣藥品的出口最大市場那生技藥品的出口達到出口有達到10億美元這事實上是有差異的那我希望的是說經濟部跟衛福部這邊能夠做一個這個業務上面的一個協調在這邊尤其是未來要準備的是要做出口的這樣子的市場的一個開拓的時候就是非常重要的那我想要請問一下就這個10億美元的\n生技跟醫藥出口當中是以醫藥醫用藥材跟西藥製造業跟學名藥原料藥跟疫苗試劑等為最大類別請問一下880億的行政院的預算當中衛福部這邊分到多少在食藥署這邊跟委員報告目前我們還在爭取中還在爭取中還在跟行政院這邊爭取跟協調\n好那再請問一下因為美國既然是我們可以出口的市場當中應該有相當的競爭力也許有像那我們如果說是開拓市場的話事實上有沒有這樣子的開拓到把這樣子現在目前我們對美的輸出把它分證到其他市場的一個需求報告委員我們正在積極的輔導我們相關的藥廠業者可以朝譬如說歐洲的國家\n因為目前食藥署也是加入很多國際組織所以我們在藥廠的GMP規範上以及我們的管理法規上都跟歐盟是一致那我們在109年也取得歐洲原料藥的第三國清單所以國內的原料藥如果要輸入到歐洲的話是不需要再經過歐洲的茶廠所以這個部分我們會鼓勵國內的藥廠盡量朝歐洲的方向發展好 那這邊我請教應該是經濟部裡面的國際貿易署因為署長\n好 劉署長您好委員好這個部分因為上週有經濟部的官員來拜訪的時候特別提到說因為上週前幾週的時候郭部長有回應到說我們不管在所謂的產業上面的這樣的多元市場的部分就是以歐盟跟印度還有土耳其為最主要的一個開拓市場這些部分那可是上週的這個來\n拜訪的時候有官員就提到是說我們這個對歐盟的地方事實上開拓的有困難等等因為很多國家可是事實上歐盟在1995年的時候就形成一個單一市場了這部分進來經濟部裡面的官員裡面還有提到說歐盟還是必須要很多國家去合約談這樣的情況之下你怎麼回應呢如果你剛才也提到說醫藥這邊也是要把快拓到市場到歐盟去的時候那請問你怎麼回應你們怎麼去看待歐盟的市場\n报告委员欧盟的确它是一个单一的市场那在医药的部分因为其实欧盟其实它有一些管理性的规定那我们针对那些管理性的规定我们基本上都会跟业者来进行一些说明它常常有些那些规定然后我们主要是让业者知道那些的规定是什么因为进入市场在药品跟其他的产品有一个很大的不一样你要进去那个市场要经过它的主管金官的认可才能够进去所以这个部分是非常重要的\n所以說是醫藥這邊因為跟人體身體健康是有關係所以他有特別的一個程序上面是這樣子好這樣了解了好那另外一部分還有就是在於核心關鍵國家核心關鍵技術在半導體這一部分很重要的是昨天我們當齊凱委員在辦這個公聽會的時候也知道的是說目前在這個關鍵核心技術的這個審查地是在所謂的投資審查署嗎是嗎\n投資投審司在投審司這部分那這邊我們都已經知道了是威澤家他已經在公開在上個月這個月都已經講到是我們未來的話就是一定要到美國去投資這部分可是這邊的投審司已經講到的是目前\n台積電還沒有提出的審查報告還沒有提出審查申請案這部分那未來的情況之下如果投審會投審師如果決定如果發現它裡面涉及到我們核心關鍵技術尤其是在高階的部分在研發IC設計設計這部分的時候那難道我們國家會我們的投審師會說NO嗎或是整個這個部分請回答\n跟委員報告就是未來投審是這邊如果收到台積電的申請因為我們投審會是一個審查平台所以我們會送審除了包括我們自己的產發署之外還包括國科會等等的技術主管機關那我們會尊重技術主管機關的意見好 所以有可能就是到時候台積電就不會去美國嗎是有可能的就是說就是尊重這個國科會上面主管機關的部分在科技上面的審查\n是有可能嗎這個就是要看那個技術主管機關審查的結果好 那事實上是可能是有可能的因為在還沒有結果審查出來之前的話Yes跟No都有可能嘛好 就這樣子 謝謝\n","vtt":"WEBVTT\n\n00:09.758 --> 00:16.149\n有請衛福部食品藥物署管理署副署長王德元先生好請衛福部副署長\n\n00:22.471 --> 00:42.098\n今天討論的主題是美國實施進口產品的國安調查對我國產業界的影響跟因應之道根據經濟部的資料顯示美國已經完成了國安調查包括鋼鋁汽車還有半導體跟藥品等等重點應該是說台灣\n\n00:44.400 --> 00:52.293\n對的出口是否對美發生逆差或是有國安的影響嗎對不對但是今天看到是貴屬的報告當中是以美國的藥品醫療器材對台灣出口的影響作為因應措施請問為什麼重點是放在\n\n00:59.700 --> 01:16.993\n跟委員報告就是因為經過我們了解事實上我們國內的藥廠出口到美國它的跟相對於美國出口到台灣它是相對我們是以進口為主那剛剛有簡單報告以去年的調查為例那我國藥廠出口到美國的金額大約是3億美元\n\n01:17.793 --> 01:28.799\n佔我們國家藥品出口的比例大概到37%但是我們從美國進口的藥品的金額大概達到5億美元大概佔我們所有輸入藥品的金額的10%\n\n01:33.342 --> 01:57.681\n可是從經濟部的報告卻顯示說美國為台灣藥品的出口最大市場那生技藥品的出口達到出口有達到10億美元這事實上是有差異的那我希望的是說經濟部跟衛福部這邊能夠做一個這個業務上面的一個協調在這邊尤其是未來要準備的是要做出口的這樣子的市場的一個開拓的時候就是非常重要的那我想要請問一下就這個10億美元的\n\n01:59.742 --> 02:16.946\n生技跟醫藥出口當中是以醫藥醫用藥材跟西藥製造業跟學名藥原料藥跟疫苗試劑等為最大類別請問一下880億的行政院的預算當中衛福部這邊分到多少在食藥署這邊跟委員報告目前我們還在爭取中還在爭取中還在跟行政院這邊爭取跟協調\n\n02:21.618 --> 02:37.176\n好那再請問一下因為美國既然是我們可以出口的市場當中應該有相當的競爭力也許有像那我們如果說是開拓市場的話事實上有沒有這樣子的開拓到把這樣子現在目前我們對美的輸出把它分證到其他市場的一個需求報告委員我們正在積極的輔導我們相關的藥廠業者可以朝譬如說歐洲的國家\n\n02:41.401 --> 03:02.590\n因為目前食藥署也是加入很多國際組織所以我們在藥廠的GMP規範上以及我們的管理法規上都跟歐盟是一致那我們在109年也取得歐洲原料藥的第三國清單所以國內的原料藥如果要輸入到歐洲的話是不需要再經過歐洲的茶廠所以這個部分我們會鼓勵國內的藥廠盡量朝歐洲的方向發展好那這邊我請教應該是經濟部裡面的國際貿易署因為署長\n\n03:11.901 --> 03:31.210\n好劉署長您好委員好這個部分因為上週有經濟部的官員來拜訪的時候特別提到說因為上週前幾週的時候郭部長有回應到說我們不管在所謂的產業上面的這樣的多元市場的部分就是以歐盟跟印度還有土耳其為最主要的一個開拓市場這些部分那可是上週的這個來\n\n03:32.791 --> 04:00.336\n拜訪的時候有官員就提到是說我們這個對歐盟的地方事實上開拓的有困難等等因為很多國家可是事實上歐盟在1995年的時候就形成一個單一市場了這部分進來經濟部裡面的官員裡面還有提到說歐盟還是必須要很多國家去合約談這樣的情況之下你怎麼回應呢如果你剛才也提到說醫藥這邊也是要把快拓到市場到歐盟去的時候那請問你怎麼回應你們怎麼去看待歐盟的市場\n\n04:02.498 --> 04:32.081\n报告委员欧盟的确它是一个单一的市场那在医药的部分因为其实欧盟其实它有一些管理性的规定那我们针对那些管理性的规定我们基本上都会跟业者来进行一些说明它常常有些那些规定然后我们主要是让业者知道那些的规定是什么因为进入市场在药品跟其他的产品有一个很大的不一样你要进去那个市场要经过它的主管金官的认可才能够进去所以这个部分是非常重要的\n\n04:32.521 --> 04:56.481\n所以說是醫藥這邊因為跟人體身體健康是有關係所以他有特別的一個程序上面是這樣子好這樣了解了好那另外一部分還有就是在於核心關鍵國家核心關鍵技術在半導體這一部分很重要的是昨天我們當齊凱委員在辦這個公聽會的時候也知道的是說目前在這個關鍵核心技術的這個審查地是在所謂的投資審查署嗎是嗎\n\n04:59.063 --> 05:15.584\n投資投審司在投審司這部分那這邊我們都已經知道了是威澤家他已經在公開在上個月這個月都已經講到是我們未來的話就是一定要到美國去投資這部分可是這邊的投審司已經講到的是目前\n\n05:16.525 --> 05:34.113\n台積電還沒有提出的審查報告還沒有提出審查申請案這部分那未來的情況之下如果投審會投審師如果決定如果發現它裡面涉及到我們核心關鍵技術尤其是在高階的部分在研發IC設計設計這部分的時候那難道我們國家會我們的投審師會說NO嗎或是整個這個部分請回答\n\n05:39.475 --> 06:08.036\n跟委員報告就是未來投審是這邊如果收到台積電的申請因為我們投審會是一個審查平台所以我們會送審除了包括我們自己的產發署之外還包括國科會等等的技術主管機關那我們會尊重技術主管機關的意見好所以有可能就是到時候台積電就不會去美國嗎是有可能的就是說就是尊重這個國科會上面主管機關的部分在科技上面的審查\n\n06:08.979 --> 06:19.198\n是有可能嗎這個就是要看那個技術主管機關審查的結果好那事實上是可能是有可能的因為在還沒有結果審查出來之前的話Yes跟No都有可能嘛好就這樣子謝謝\n\n","segments":[{"start":9.758,"end":16.149,"text":"有請衛福部食品藥物署管理署副署長王德元先生好請衛福部副署長"},{"start":22.471,"end":42.098,"text":"今天討論的主題是美國實施進口產品的國安調查對我國產業界的影響跟因應之道根據經濟部的資料顯示美國已經完成了國安調查包括鋼鋁 汽車還有半導體跟藥品等等重點應該是說台灣"},{"start":44.4,"end":52.293,"text":"對的出口是否對美發生逆差或是有國安的影響嗎對不對但是今天看到是貴屬的報告當中是以美國的藥品醫療器材對台灣出口的影響作為因應措施請問為什麼重點是放在"},{"start":59.7,"end":76.993,"text":"跟委員報告就是因為經過我們了解事實上我們國內的藥廠出口到美國它的跟相對於美國出口到台灣它是相對我們是以進口為主那剛剛有簡單報告以去年的調查為例那我國藥廠出口到美國的金額大約是3億美元"},{"start":77.793,"end":88.799,"text":"佔我們國家藥品出口的比例大概到37%但是我們從美國進口的藥品的金額大概達到5億美元大概佔我們所有輸入藥品的金額的10%"},{"start":93.342,"end":117.681,"text":"可是從經濟部的報告卻顯示說美國為台灣藥品的出口最大市場那生技藥品的出口達到出口有達到10億美元這事實上是有差異的那我希望的是說經濟部跟衛福部這邊能夠做一個這個業務上面的一個協調在這邊尤其是未來要準備的是要做出口的這樣子的市場的一個開拓的時候就是非常重要的那我想要請問一下就這個10億美元的"},{"start":119.742,"end":136.946,"text":"生技跟醫藥出口當中是以醫藥醫用藥材跟西藥製造業跟學名藥原料藥跟疫苗試劑等為最大類別請問一下880億的行政院的預算當中衛福部這邊分到多少在食藥署這邊跟委員報告目前我們還在爭取中還在爭取中還在跟行政院這邊爭取跟協調"},{"start":141.618,"end":157.176,"text":"好那再請問一下因為美國既然是我們可以出口的市場當中應該有相當的競爭力也許有像那我們如果說是開拓市場的話事實上有沒有這樣子的開拓到把這樣子現在目前我們對美的輸出把它分證到其他市場的一個需求報告委員我們正在積極的輔導我們相關的藥廠業者可以朝譬如說歐洲的國家"},{"start":161.401,"end":182.59,"text":"因為目前食藥署也是加入很多國際組織所以我們在藥廠的GMP規範上以及我們的管理法規上都跟歐盟是一致那我們在109年也取得歐洲原料藥的第三國清單所以國內的原料藥如果要輸入到歐洲的話是不需要再經過歐洲的茶廠所以這個部分我們會鼓勵國內的藥廠盡量朝歐洲的方向發展好 那這邊我請教應該是經濟部裡面的國際貿易署因為署長"},{"start":191.901,"end":211.21,"text":"好 劉署長您好委員好這個部分因為上週有經濟部的官員來拜訪的時候特別提到說因為上週前幾週的時候郭部長有回應到說我們不管在所謂的產業上面的這樣的多元市場的部分就是以歐盟跟印度還有土耳其為最主要的一個開拓市場這些部分那可是上週的這個來"},{"start":212.791,"end":240.336,"text":"拜訪的時候有官員就提到是說我們這個對歐盟的地方事實上開拓的有困難等等因為很多國家可是事實上歐盟在1995年的時候就形成一個單一市場了這部分進來經濟部裡面的官員裡面還有提到說歐盟還是必須要很多國家去合約談這樣的情況之下你怎麼回應呢如果你剛才也提到說醫藥這邊也是要把快拓到市場到歐盟去的時候那請問你怎麼回應你們怎麼去看待歐盟的市場"},{"start":242.498,"end":272.081,"text":"报告委员欧盟的确它是一个单一的市场那在医药的部分因为其实欧盟其实它有一些管理性的规定那我们针对那些管理性的规定我们基本上都会跟业者来进行一些说明它常常有些那些规定然后我们主要是让业者知道那些的规定是什么因为进入市场在药品跟其他的产品有一个很大的不一样你要进去那个市场要经过它的主管金官的认可才能够进去所以这个部分是非常重要的"},{"start":272.521,"end":296.481,"text":"所以說是醫藥這邊因為跟人體身體健康是有關係所以他有特別的一個程序上面是這樣子好這樣了解了好那另外一部分還有就是在於核心關鍵國家核心關鍵技術在半導體這一部分很重要的是昨天我們當齊凱委員在辦這個公聽會的時候也知道的是說目前在這個關鍵核心技術的這個審查地是在所謂的投資審查署嗎是嗎"},{"start":299.063,"end":315.584,"text":"投資投審司在投審司這部分那這邊我們都已經知道了是威澤家他已經在公開在上個月這個月都已經講到是我們未來的話就是一定要到美國去投資這部分可是這邊的投審司已經講到的是目前"},{"start":316.525,"end":334.113,"text":"台積電還沒有提出的審查報告還沒有提出審查申請案這部分那未來的情況之下如果投審會投審師如果決定如果發現它裡面涉及到我們核心關鍵技術尤其是在高階的部分在研發IC設計設計這部分的時候那難道我們國家會我們的投審師會說NO嗎或是整個這個部分請回答"},{"start":339.475,"end":368.036,"text":"跟委員報告就是未來投審是這邊如果收到台積電的申請因為我們投審會是一個審查平台所以我們會送審除了包括我們自己的產發署之外還包括國科會等等的技術主管機關那我們會尊重技術主管機關的意見好 所以有可能就是到時候台積電就不會去美國嗎是有可能的就是說就是尊重這個國科會上面主管機關的部分在科技上面的審查"},{"start":368.979,"end":379.198,"text":"是有可能嗎這個就是要看那個技術主管機關審查的結果好 那事實上是可能是有可能的因為在還沒有結果審查出來之前的話Yes跟No都有可能嘛好 就這樣子 謝謝"}]}}},"gazette":{"lineno":906,"blocks":[["劉委員書彬：（11時54分）有請衛福部食品藥物管理署副署長王德原先生。"],["主席：好，請衛福部王副署長。"],["王副署長德原：委員好。"],["劉委員書彬：副署長你好。今天討論的主題是美國實施進口產品國安調查對我國產業界之影響及因應之道，根據經濟部的資料顯示，美國已經完成了國安調查，包括鋼鋁、汽車，還有半導體跟藥品等等，重點應該是臺灣的出口是否對美發生逆差或是有國安的影響嘛，對不對？但是今天看到貴署的報告當中是以美國的藥品、醫療器材對臺灣出口的影響作為因應措施，請問為什麼重點是放在這個地方？"],["王副署長德原：跟委員報告，就是因為經過我們了解，事實上我們國內的藥廠出口到美國相對於美國出口到臺灣，我們是以進口為主。簡單報告，以去年的調查為例，我國藥廠出口到美國的金額大約是3億美元，占我們國家藥品出口的比例大概到37%，但是我們從美國進口藥品的金額大概達到5億美元，大概占我們所有輸入藥品金額的10%。"],["劉委員書彬：好，可是經濟部的報告卻顯示美國為臺灣藥品出口最大市場，生技藥品的出口額達到10億美元，事實上是有差異的，我希望經濟部跟衛福部能夠做一個業務上面的協調，尤其未來要準備做出口市場開拓的時候，這是非常重要的。","我想要請問一下，這個10億美元的生技跟醫藥出口當中是以醫用藥材、西藥製造業、學名藥、原料藥跟疫苗試劑等為最大類別，請問一下在880億的行政院預算當中，衛福部食藥署這邊分到多少？"],["王副署長德原：跟委員報告，目前我們還在爭取中。"],["劉委員書彬：還在爭取中？"],["王副署長德原：還在跟行政院爭取跟協調。"],["劉委員書彬：好，再請問一下，因為美國既然是我們可以出口的市場，應該有相當的競爭力，我們如果開拓市場的話，事實上有沒有把目前我們對美的輸出開拓分散到其他市場的需求？"],["王副署長德原：報告委員，我們正在積極輔導相關的藥廠業者可以朝譬如歐洲的國家，因為目前食藥署也加入很多國際組織，所以我們在藥廠的GMP規範以及我們的管理法規上都跟歐盟是一致的，我們在109年也取得歐洲原料藥的第三國清單，所以國內的原料藥如果要輸入到歐洲是不需要再經過歐洲的查廠，這個部分我們會鼓勵國內的藥廠儘量朝歐洲的方向發展。"],["劉委員書彬：好。這邊我要再請教經濟部國際貿易署，劉署長你好。"],["劉署長威廉：委員好。"],["劉委員書彬：這個部分上週有經濟部官員來拜訪的時候特別提到，因為前幾週郭部長有回應到，說我們不管在所謂的產業上面這樣多元市場的部分，就是以歐盟、印度還有土耳其為最主要的開拓市場，可是上週來拜訪的時候有官員就提到我們對歐盟事實上開拓有困難什麼等等，說因為有很多國家；可是事實上歐盟在1995年的時候就形成一個單一市場了，竟然經濟部的官員還提到在歐盟還是必須要很多國家去約談，這樣的情況之下你怎麼回應呢？如果你剛才也提到醫藥也是要開拓市場到歐盟的時候，請問你怎麼回應？你們怎麼去看待歐盟的市場？"],["劉署長威廉：報告委員，歐盟的確是一個單一的市場，在醫藥的部分因為歐盟有一些管理性的規定，我們針對那些管理性的規定基本上都會跟業者進行一些說明，常常有一些規定，然後我們主要是讓業者知道那些規定是什麼，因為進入市場在藥品跟其他的產品有一個很大的不一樣，要進去那個市場要先經過主管機關認可才能夠進去，所以這個部分是非常重要的。"],["劉委員書彬：好，所以是醫藥因為跟人體身體健康有關係，所以有特別的程序，是這樣子？"],["劉署長威廉：是。"],["劉委員書彬：好，這樣了解了。另外一部分就是國家核心關鍵技術在半導體這一部分，很重要的是昨天張啓楷委員在辦公聽會的時候，也說到目前這個關鍵核心技術審查是在所謂的投資審查署嗎？是嗎？"],["劉署長威廉：經濟部投審司。"],["劉委員書彬：在投審司。我們都已經知道魏哲家已經公開在上個月和這個月都講到未來就是一定要到美國去投資，可是投審司講到的是，台積電目前還沒有提出審查申請案，未來的情況，如果投審司這邊發現它裡面涉及到我們國家的核心關鍵技術，尤其是高階、IC設計研發這部分的時候，難道我們的投審司會說No嗎？這個部分請回答。"],["蘇副司長琪彥：跟委員報告，未來投審司如果收到台積電的申請，因為投審會是一個審查平臺，所以我們會送審，除了我們自己的產發署之外，還包括國科會等等技術主管機關，我們會尊重技術主管機關的意見。"],["劉委員書彬：所以有可能台積電到時候就不會去美國嗎？是有可能的嗎？如果尊重國科會、主管機關在科技上面的審查，是有可能的嗎？"],["蘇副司長琪彥：這個就是要看技術主管機關審查的結果。"],["劉委員書彬：好，事實上是有可能的，因為在審查結果還沒有出來之前，Yes跟No都有可能嘛！好，就這樣子，謝謝。"],["主席：謝謝劉書彬委員。","下一位請何欣純委員發言。我們中午不休息，延長開會時間到詢答結束。"]],"agenda":{"page_end":332,"meet_id":"委員會-11-3-19-10","speakers":["蔡易餘","賴瑞隆","邱議瑩","鄭正鈐","張啓楷","張嘉郡","林岱樺","楊瓊瓔","謝衣鳯","陳亭妃","呂玉玲","邱志偉","鍾佳濱","劉書彬","何欣純","徐欣瑩","陳培瑜","陳冠廷","黃捷"],"page_start":275,"meetingDate":["2025-04-23"],"gazette_id":"1144001","agenda_lcidc_ids":["1144001_00007"],"meet_name":"立法院第11屆第3會期經濟委員會第10次全體委員會議紀錄","content":"邀請經濟部部長、國家發展委員會主任委員及衛生福利部首長就「美國實施進口產品國安調查對\n我國產業之影響及因應之道」進行報告，並備質詢","agenda_id":"1144001_00006"}}}