建立中藥法規諮詢系統，研擬法規鬆綁及改革制度

余萬能
中華民國藥師公會全國聯合會
為維護民眾中藥使用安全，建立中藥產業有利發展的條件，研擬中藥法規鬆綁及改革制度，建置有效的法規管理機制，本計畫整合行政及法律資源，由具法學及藥學執業實務背景之專業人員，組織「中藥法政諮詢小組」，每月定期就中醫藥委員會所交議之法規案件，及每週定期蒐集、整理美國、歐盟、日本及中國大陸中藥藥事法律規章解釋令函等所得之資訊，提供法律諮詢意見，並彙整有關中藥之法規資訊、判解函釋、裁判書、行政規章及解釋令函等相關法律資料，提供中醫藥委員會更新「中藥法規資料庫」網頁資訊，並整合法律見解，問卷調查分析業界對法規鬆綁之意見，研擬「藥物製造工廠設廠標準」、「藥物科技研究發展獎勵辦法」、「健康食品管理法及施行細則」、「藥品查驗登記審查準則」、「藥品優良臨床試驗準則」及「植物抽取新藥臨床試驗基準」之修正草案，邀集中藥業界、中藥藥學及法學專家學者研討後，依照立法格式，擬具修正條文草案，提供中醫藥委員會作修法政策方向。
關鍵字：中藥法規；法政諮詢；法規鬆綁

Study on the establishment of consulting system and reorganization of regulations on Chinese medicines

Yu, Wan Nan
National Union of Pharmacist Associations of Republic of China
The aim of this study is to establish a good management and guidance mechanism for the Traditional Chinese Medicine (TCM)industry through the reorganization of the regulations so that the steadily growth of TCM industry can be reached. In this study, integration of the resources of the administrative laws, formation of a task force of consultation regarding law and policy-making of Traditional Chinese Medicine from different backgrounds, have been conducted. The task force discussed the legal cases that the Committee of Chinese Medicine and Pharmacy handed in monthly. Besides, collecting and sorting out the legal rules of U.S.A., European Union, Japan and Mainland China have been carried out in this study as well, so that the legal advisory opinion can be provided weekly to the related authorities. Furthermore, in this study the regulations, interpretations, commentaries, mandates, court verdicts and the relevant laws, regulations, administrative rules have been put in order. The information has been provided for Committee of Chinese Medicine and Pharmacy to update the “Data Bank of regulations of Traditional Chinese Medicine”.
關鍵字：regulations of herbal medicine；consultation of regulation and policy-making；loosened control