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    Please use this identifier to cite or link to this item: http://tkuir.lib.tku.edu.tw:8080/dspace/handle/987654321/33532

    Title: 新藥在台灣上市之關鍵因素的實證研究
    Other Titles: An empirical study of key factors of new drug launching in Taiwan
    Authors: 林信江;Lin, Hsin-chiang
    Contributors: 淡江大學企業管理學系碩士在職專班
    徐悌;Hsu, Ti
    Keywords: 新藥;上市關鍵因素;new drug;key launching factors
    Date: 2006
    Issue Date: 2010-01-11 04:15:12 (UTC+8)
    Abstract: 一個新藥從研發到上市,其過程繁瑣且耗時多年,同時面臨衛生署嚴格把關。
    廠商期待衛生署新藥的審核過程中都不該有個人立場的偏好,審查過程中,應准許廠商的代表和衛生署審查員進行對話和協商。爾後,應與送案的藥商分享案件 詳細審核的過程和最終決定。
    針對衛生署新藥法規化學優先審查機制,本研究結果原開發廠和代理商共23家同意以新小分子實體(NME, new molecular entities)是指活性組成尚未被核准過的藥物做優先順序審查。另外,認為活性組成分已經被核准過的藥物,但要更改生產製造商,或是在1962年以前上市的藥物,做優先順序審查者,以國內藥廠居多共9家。
    因素四「化學優先審查機制」與公司型態、員工人數、資本額、年營業額和公司成立年限作變異數異分析,分析結果只有因素三「治療效果分類做優先順序審查機制」在與公司型態分析有差異,其中代理商顯示較為同意( p-value= 0.007)
    It takes a very long time from a new drug development to launching on market and health authorities inspect the process strictly. In aim of this study section is to discuss the key launching factors of the process from registration document preparing to get new- drug approvals.
    First we design the questionnaire by relative literatures then revised by pharmaceutical experts.
    We investigate all regulatory managers including original companies, local agency and manufacturers.
    We receive 90 effective samples totally. After the analysis of the samples, major findings of this study were highlighted as follow,
    1. There are 4 key launching factors of new drug in Taiwan as below,
    (1)Policy implement
    For speed up a new drug review, we hope health authorities should clearly defined product
    registration procedures and hold a presentation of ecessary document by regulatory agencies and increased transparency during NDA review.
    (2)Review criteria
    The right for dialogue and negotiation between regulatory experts and
    pharmaceutical companies during registration procedures and final decision
    is necessary. Also, we hope that staff and committee members have no
    personal conflicts and interest.
    (3)Treatment potential classification of priority review
    Most companies agree that Taiwanese health authorities assign review priority
    based on treatment potential classification. Priority review drug will be reviewed
    within 6 months and standard drugs be reviewed within one year.
    (4)Chemical classification of priority review
    23 original companies and agency agree Taiwanese health authorities assign
    NME type review priority but most local manufacturers consider already
    marketed drug product must be review firstly.
    2. Only the third factor of treatment potential priority has a significant difference on
    local agent group. (p-value= 0.007)
    Appears in Collections:[企業管理學系暨研究所] 學位論文

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