頁籤選單縮合
題 名 | 中藥法規之標準化與協合化研究=Study on the Standardization and Harmonization of the Regulations of Traditional Chinese Medicine |
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作 者 | 余啟民; | 書刊名 | 中醫藥年報 |
卷 期 | 3 2014.12[民103.12] |
頁 次 | 頁(62)1-(62)262 |
分類號 | 413.023 |
關鍵詞 | 標準化; 協和化; 藥事法; 中藥; Tandardization; Harmonization; Pharmaceutical affairs law; Traditional Chinese medicine; |
語 文 | 中文(Chinese) |
中文摘要 | 中藥乃具我國文化傳統與產業價值,世界華人所在國家亦皆通俗使用,其與現代化科技方法結合後,仍須充分整合( integrated)兩岸相關管理規定,俾為中藥產業打通兩岸市場之屏障。本計畫乃將兩岸藥事法有關中藥相關法規條文為基礎,依產品管理及專業人員服務管理分類,逐法逐條整理比較兩岸相關法律資訊之差異,作成相關法規差異分析,比較分析兩岸現有中藥法規對中藥生物科技研發的認定與產業推動相關規定,以台灣複方濃縮中藥輸出至中國大陸因法規問題難度甚高,由中藥及法學專家學者組成中藥法規諮詢小組,召開三次會議,依據 ECFA協議之精神,依「兩岸藥品審批及查驗登記制度」及「兩岸醫藥產品定位及供應服務制度」,作成議案,邀請大陸中醫藥及法學專家學者,與我國產、官、學、研專家學者,召開「海峽兩岸中醫藥法規研討會」,研討兩岸相關中藥法規趨勢,及未來中藥在 ECFA協議下之問題,對我國可能產生之影響,整合台灣中藥查驗登記及管理制度之法規,配合中醫藥委員會政策,以標準化及協和化擬定適用我國之中藥材輸入管理體系架構,擬具法規基準及政策建議意見,提具修正草案,提供政府政策參考。 |
英文摘要 | Chinese medicine is a cultural tradition of our country and it possesses high industrial value. Chinese medicine is used by Chinese population all over the world. Due to its combination with modern technology, full integration between the laws and regulations of Taiwan and Mainland China is a must to break the barrier between the two markets. We did article-to-article comparison of regulations in Taiwan and Mainland China related to Chinese medicine based on product management and service management of professionals. The articles related to the affirmation of biotechnical R&D and industrial promotion in current Chinese medicine regulations across the Taiwan Straits were analyzed. We also invited Chinese medicine and legislation specialists to form a task force of consultation regarding regulations of TCM. During three meetings, the task force made a motion related to “management system of inspection and registration” and “the product definition and management of supply of professional service” according to the spirit of ECFA. And the motion was proposed to a “Symposium on the Standardization and Harmonization of the Regulations of Traditional Chinese Medicine between Taiwan and Mainland China” in order to investigate the trends in regulating Chinese medicine and the effects under the ECFA, in which experts of Chinese medicine and legislation from Mainland China were invited. Incorporated with policies of CCMP, we integrated Taiwan regulations on management of Chinese medicine import into a standardized and harmonized framework in this project; furthermore, appropriate regulations, guidelines and policy suggestions about inspection/registration and management of Chinese medicine are proposed, and the draft amendment clauses are formulated to the government for policy making. |
本系統中英文摘要資訊取自各篇刊載內容。