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    題名: 新藥在台灣上市之關鍵因素的實證研究
    其他題名: An empirical study of key factors of new drug launching in Taiwan
    作者: 林信江;Lin, Hsin-chiang
    貢獻者: 淡江大學企業管理學系碩士在職專班
    徐悌;Hsu, Ti
    關鍵詞: 新藥;上市關鍵因素;new drug;key launching factors
    日期: 2006
    上傳時間: 2010-01-11 04:15:12 (UTC+8)
    摘要: 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。
    本研究從藥廠本身對新藥查驗登記資料準備,爾後,送衛生署審查直到取得許可證的流程,作為研究探討影響新藥上市關鍵因素。
    本研究依據相關文獻與藥學專家確認問卷內容,採用全面調查跨國藥廠、代理商以及國內藥廠之法規經理作填寫,究共回收90份有效問卷其結果如下:
    一、研究數據經由因素分析後得到四個因素如下:
    (一)「政策推行」
    為加速新藥的上市,廠商希望由衛生署明確訂定藥品查驗登記的必備文件與資料內容,同時經常舉辦說明會和協助廠商的諮詢和補件,是有利於新藥法規政策的推行。此外,台灣衛生署若能增加法規政策的透明度,相信一定能讓廠商信服衛生署的決定是公正的。
    (二)「政策審核標準」
    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。
    (三)「療效優先審查機制」
    研究結果充分顯示大部分廠商同意,衛生署將療效優先審查機制納入新藥審查機制,新藥若是屬於「優先審查藥品」的分類應該可以在6個月內經過衛生署審查通過並取得許可證。若是屬於「標準審核藥品」的分類應該可以在12個月內經過衛生署審查通過並取得許可證。
    (四)「化學優先審查機制」
    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。
    二、本研究從各因素中因素一「政策推行」因素二「政策審核標準」因素三「療效優先審查機制」
    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)
    顯示於類別:[企業管理學系暨研究所] 學位論文

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