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題 名 | 研議單味中藥磨粉製劑核發許可證之作業流程及辦理發證初審作業=Study on Standardize the Registration Applications and License Issuing Procedures and Implement the Initial Stage License Issuing |
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作 者 | 余萬能; | 書刊名 | 中醫藥年報 |
卷 期 | 光碟版1:9 2012.10[民101.10] |
頁 次 | 頁334-411 |
專 輯 | 中醫藥產業實務規範 |
分類號 | 413.94 |
關鍵詞 | 單味中藥磨粉製劑; 藥事法; 查驗登記; 核發許可證; Powder form of single Chinese herbal medicine; Pharmaceutical affair law; Registration application; License issuing; |
語 文 | 中文(Chinese) |
中文摘要 | 單味中藥磨粉為藥事法所規範之法定藥品,依同法第 39條之規定,應申請查驗登記,核發許可證,方得製造販賣。本計畫之目的係由藥事法相關規定,釐清單味中藥磨粉製劑核發許可證之法規相關問題,建立申請查驗登記之條件,以及核發許可證之作業流程,並依該流程執行初審作業。本計畫由具法學及藥學執業實務背景之專業人員,就現行實務之作業方式,依藥事法之規定,分析比較適法性之問題,以簡化作業方式,研擬申請查驗登記之條件,以及核發許可證之作業流程,協助中醫藥委員會擬稿,依法定程序陳報行政院衛生署完成公告作業。 行政院衛生署於 98年 7月 14日公告單味中藥粉末以原料藥申請藥品查驗登記簡化作業方式,計有 64家藥商申請 644品項共計 4,860件,本計畫業依中醫藥委員會所核定之作業流程,全部完成初審作業。完成初審作業之 4,860件中,合乎簡化作業程序 4,465件(91.9%)。不合簡化作業程序須常規審查計有 395件,其原因包括毒劇藥、非法定典籍等。本計畫並檢討作業內容及作業方式,提供政府繼續執行之參考。 |
英文摘要 | Powder form of single Chinese Herbal Medicine is the official medicine recognized by Pharmaceutical Affair Law. According to the clause 39 of Pharmaceutical Affair Law, only after registration application and license issuing, can the Powder form of single Chinese Herbal Medicine be merchandised. The purpose of this project is to clarify the issues on license issuing related regulation in Pharmaceutical Affair Law, to build the registration application norm and standard procedures of license issuing, and to process all the examinations and approvals by the norms and standards. The professionals with pharmacy practice and jurisconsult background will analyze/compare the current registration problems, and then simplify the procedures to fit Taiwanese Government’s principals in Pharmaceutical Affair Law. We standardized all the registration applications and license issuing procedures, and then implemented the initial stage license issuing after Committee on Chinese Medicine and Pharmacy to send in Department of Health, Executive Yuan officially to bulletin. The Department of Health announced the bulletin “The simplified procedures of registration application of powder form of single Chinese Herbal Medicine” on July 14, 2009. 4860 applications distributed in 664 categories were filed by 64 pharmaceutical factories. Subsequently, the all 4860 applications were reviewed and implemented to the initial stage license issuing according to the operation procedure approved by CCMP. 4465 (91.9%) of them satisfied the regulations of the previously announced bulletin of simplified procedures, and the other 395 applications need be conducted through regular procedures due to their poison/potent characteristic, utilization of non-statutory sources, or other reasons. In the end of this project, we studied and discussed all the procedures and the structure, with all the results and conclusions to be reported to Taiwanese Government for regulation reference. |
本系統中英文摘要資訊取自各篇刊載內容。