Cde.org.tw Website Review


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Traffic and Value

Is cde.org.tw legit?
Website Value $1225
Alexa Rank 555172
Monthly Visits 13604
Daily Visits 454
Monthly Earnings $68.02
Daily Earnings $2.27
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Cde.org.tw Server Location

Country: Taiwan
Metropolitan Area: Not defined
Postal Reference Code: Not defined
Latitude: 23.5
Longitude: 121




Summarized Content

學名藥查驗登記CTD格式送件專案法規輔導徵求公告 (102年10月15日起開放徵求) Copyright © Center for Drug Evaluation, All Rights Reserved. 財團法人醫藥品查驗中心 Center for Drug 台北市南港區11557忠孝東路六段465號3樓 3F, No.465, Sec.6, Zhongxiao E. Rd., Taipei 11557, Taiwan. R.O.C. Tel.: 886-2-8170-6000  Fax.: 886-2-8170-6001、886-2-8170-6002 最佳瀏覽器:IE7.0 最佳瀏覽解析度:1024x768


Cde Main Page Content

HTML Tag Content Informative?
Title: 財團法人醫藥品查驗中心 Center for Drug Evaluation, Could be improved
Description: Not set Empty
H2: CDE活動主題Is it informative enough?

Other Helpful Websites and Services for Cde

Internal Pages

/Pages/default.aspx:
Title

財團法人醫藥品查驗中心 Center for Drug Evaluation, Taiwan

Description

Not defined

H2

CDE活動主題

/epaper/Pages/RegMed_Index.aspx:
Title

CDE電子報系列 - 當代醫藥法規月刊

Description

Not defined

/FAQ/NDA/Pages/%e7%94%b3%e8%ab%8b%e5%8f%8a%e6%b3%95%e8%a6%8f%e7%9b%b8%e9%97%9c.aspx:
Title

新藥查驗登記(NDA)-申請及法規相關

Description

Not defined

H1

請問如何辦理輸入藥品查驗登記?

H3

辦理輸入藥品查驗登記者須有藥商資格,藥商之申請請於當地衛生局辦理。辦理藥品查驗登記,請參考藥品查驗登記審查準則,檢附相關資料辦理之。 藥品查驗登記審查準則可由以下方式下載:(一)衛生福利部首頁 >本署各單位 > 藥政處(99年1月1日起改隸食品藥物管理局醫粧組與藥品組)  >相關法規 >法規與基準  >2. 藥品管理  >藥品查驗登記審查準則 或 (二)全國法規資料庫  >法規類別  >衛生福利法規  > 藥政目 > 藥品查驗登記審查準則。 另外,亦需辦理工廠資料備查(請參考95年11月13日署授食字第0951401750號公告」,國外工廠整份文件資料須於當地最高衛生主管機關簽證後送署申辦。

/FAQ/BSE/Pages/%e7%94%b3%e8%ab%8b%e5%b8%b8%e8%a6%8b%e5%95%8f%e9%a1%8c.aspx:
Title

銜接性試驗評估(BSE)-申請及法規相關

Description

Not defined

H1

哪些新藥須申請銜接性試驗評估?應檢附資料為何?

H3

藥事法第7條所稱新藥,係指經中央衛生主管機關審查認定屬新成分、新療效複方或新使用途徑製劑之藥品。 98年02月13日衛署藥字第0980303366號令已明訂新成分新藥須於其查驗登記申請案前或與查驗登記申請案同時申請銜接性試驗評估。其餘非屬新成分新藥或未經中央衛生主管機關公告應申請銜接性試驗評估之藥品,原則上皆不需要申請銜接性試驗評估。 申請銜接性試驗評估,應填具銜接性試驗評估查檢表,並檢附藥品之完整臨床試驗數據資料(complete clinical data package),且宜含亞洲人種資料。

All the information about cde.org.tw was collected from publicly available sources

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