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題 名 | 兩岸炮製規範、GMP及中藥藥政管理異同之探討=Comparison of Guideline for Processing GMP and Pharmaceutical Administration of Chinese Herbal Medicine between Taiwan and Mainland China |
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作 者 | 溫國慶; | 書刊名 | 中醫藥年報 |
卷 期 | 25:4 2007.10[民96.10] |
頁 次 | 頁209-273 |
專 輯 | 中醫藥品質管理相關研究 |
分類號 | 414.4 |
關鍵詞 | 中藥藥政管理; 藥品優良製造標準; 中藥材炮製; The management of Chinese medicine administration; GMP; The processing of Chinese herbal medicine; |
語 文 | 中文(Chinese) |
中文摘要 | 本計畫參訪大陸之中央、地方衛生行政及檢驗機構,以及GMP工廠及中藥材炮製工廠,實地了解中藥藥政管理、GMP認證及作業之情形,並蒐集兩岸中藥藥政相關法規、規範及管理層級、架構及分工等資料。經彙整比對上述資料,可了解兩岸在中藥藥政管理之法規堪稱完備,管理架構大陸為三級制,臺灣為二級制。行政管理與檢驗分工大陸為兩者合一,臺灣兩者分開。GMP執行方面,有關中藥製劑廠方面,大陸於1998年8月1日推行至2003年7月1日完成。臺灣方面,有關濃縮製劑廠與以西藥劑型之中藥1982年5月26日推行至1988年12月31日完成,傳統劑型則自2000年5月2日推行,預定於2005年2月28日完成。有關中藥飲片方面,大陸於2003年1月30日推行,預定於2008年1月1日完成,臺灣亦以著手宣導規劃。本計畫提出中藥飲片GMP規範建議草案,供政府管理單位參考。 |
英文摘要 | In the present project, we visited Chinese herbal medicine relevant central (SFDA) and regional authorities, laboratories and GMP factories of Chinese herbal medicine processing in main land China. In addition, we collected information of Chinese herbal medicine-related policies, regulations, management levels, structures, division of labor etc. Consequently, the management of Chinese medicine administration, GMP certification, and execution were well understood. After compiling and comparing the information, regulations of the management of Chinese medicine seem to be adequacy for the Two Sides of the Taiwan Straits. In main land China, the structure of management is classified into 3-level whereas in Taiwan, 2-level, and the management is combined with laboratory as one unit in the administration (SFDA) for the former whereas for the latter, they are separated. As to the execution of GMP, it was carried out since Oct. 1, 1998 and accomplished by date of July 1, 2003 for factories of Chinese herbal preparation in main land China. In Taiwan, it was carried out since May 26, 1982 and accomplished by date of Dec. 31, 1988 for factories of Chinese herbs in concentrated and western drug dosage forms. Regarding to the traditional dosage forms, it was carried out since May 2, 2000, and fix in advance to be accomplished by date of Feb. 28, 2005. Concerning Chinese herbal slices, in main land China, the execution of GMP has carried out since Jan. 30, 2003, and fixed in advance to be accomplished by date of Jan. 1, 2008, whereas in Taiwan, it just begins to plan to put into effect. Finally, we provide DOH with suggestion draft of GMP for Chinese herbal slices in order to elevate the quality of Chinese herbal slices. |
本系統中英文摘要資訊取自各篇刊載內容。