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題名 | 我國新藥審查機制之改革與展望=The Reform and Prospects of Taiwan's New Drug Review System |
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作者姓名(中文) | 潘香櫻; 王兆儀; 鄒玫君; 康照洲; 葉嘉新; 陳瑩如; 高純琇; | 書刊名 | 食品藥物研究年報 |
卷期 | 4 2013.11[民102.11] |
頁次 | 頁458-468 |
分類號 | 418.1 |
關鍵詞 | 新藥查驗登記; 優先審查機制; 精簡審查機制; 國產創新藥品查驗登記; 藥品風險管理計畫; 植物藥新藥; 生物相似性藥品; 新藥查驗登記加速核准機制; NCE-2; New drug application; Priority evaluation; Abridged evaluation; Domestic innovative products evaluation; Risk evaluation and mitigation strategy or risk management plan; REMS /RMP; Botanical drug products; Biosimilar products; Accelerated approval; |
語文 | 中文(Chinese) |
中文摘要 | 自99年1月1日TFDA成立以來,極力推行新藥審查機制改革,改革方案始於整合並強化 TFDA與醫藥品查驗中心之審查能量,重新定位藥品諮議小組與檢討提會原則,繼而進行各項新藥審查機制之改革,並致力審查公開透明化,加強內部品質稽核,全面提升藥品審查品質與效率。三年多來成果包括, 100與101年分別完成 119件與 118件新藥查驗登記案之審查;在新藥查驗登記優先審查機制方面, 2件已結案案件平均審查天數為 200天,較原限辦時間縮短了 56%;國產創新藥品快速審查機制方面, 3件核准案件之平均審查天數為 112天,較原限辦時間縮短了 44%;在建立核准函核發機制方面,至目前超過百項產品,廠商是由核准函提早得知審查結果。而未來規劃將持續推動之改革方案,如優良審查規範、醫藥法規諮詢輔導及國際合作與區域 (包括兩岸 )法規交流等,將使我國新藥審查機制更趨於國際化,有利我國建構符合國際潮流之醫藥法規環境與體系,確保國人用藥安全與公衛福祉,並促進我國生技醫藥產業的發展。 |
英文摘要 | Since the establishment of the Taiwan Food and Drug Administration of the Department of Health on January 1st, 2010, the Administration have introduced the reform of the new drug review programs and developed the multiple new drugs review path. The reform programs started from the integration and the enhancement of the review capacity of the Food and Drug Administration and Center for Drug Evaluation, as well as the reposition of the advisory committee with new proposal principles. The implementation of the new drug review reform programs in the past three years has gradually shown good results. The number of new drug approval cases in 2011 and 2012 were 119 and 118 respectively. The mean approval time of the priority review system was around 200 days on two closed cases, which was shortened by 56% of the original approval time. In the domestic innovative products evaluation program, the average approval time was 112 days based on three approved cases, which was 44% less than the original approval time. For more than one hundred products, NDA applicants were notified the results of the review earlier by an approval letter. In the future, more reform programs will continue, such as conducting good review practice, improving the pharmaceutical regulations counseling, the international cooperation and regional (including cross strait cooperation) regulations exchanges, which will be beneficial to construct an international pharmaceutical regulatory environment and system. We are committed to ensure human medication safety and the well-being of public health, and to promote the development of Taiwan’s biotechnology and pharmaceutical industry. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。