中藥法規之標準化與協合化研究

余啟民
中華民國藥事品質改革協會
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。本計畫乃以國內藥事法有關中藥相關法規條文為基礎，逐法逐條整理比較大陸中藥藥事相關法規，由中藥及法學專家學者組成中藥法規諮詢小組，依據ECFA協議之精神，分析比較雙方管理之異同，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，及對我國可能產生之影響，研議尋求因應對策，整合台灣中藥查驗登記及管理制度之法規，以標準化及協和化擬定適用我國之中藥管理體系架構，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。
關鍵字：標準化、協和化、藥事法、中藥

Study on the Standardization and Harmonization of the Regulations of Traditional Chinese Medicine

Yu, Chi-Min
Quality Improvement for Pharmaceutical Affairs Association, Taiwan
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, fully integration between the laws and regulations of Taiwan and Mainland China is a must to break the barrier between the two markets. Based on articles of Taiwan Pharmaceutical Affairs Law related to Chinese medicine, this plan will compare it with the regulations of Mainland China and form a task force of consultation regarding regulations of TCM from different backgrounds including medical, pharmaceutical and legislation specialists. The task force will analysis and compare the management framework of Chinese medicine between Taiwan and Mainland China according to the spirit of ECFA, and make a recommendation based on "management system of inspection and registration" and "the product definition and management of supply of professional service". In order to investigate the trends in regulating Chinese medicine and the effects under the ECFA, this study plans to invite experts of Chinese medicine and legislation from Mainland China to a "Symposium on the Standardization and Harmonization of the Regulations of Traditional Chinese Medicine between Taiwan and Mainland China". In this project we will integrate the regulations of management of Chinese medicine of Taiwan to a standardized and harmonized framework. Further, appropriate regulations, guidelines and policy suggestions will be proposed, and the draft amendment clauses will be formulated to the government for policy making.
關鍵字：standardization、harmonization、Pharmaceutical Affairs Law、Traditional Chinese Medicine