整編中藥法規解釋令函，建立中藥法規資料庫研究計畫

余萬能
中華民國藥師公會全國聯合會
為使中藥產業建置良好的管理與輔導機制，透過法規的整編過程，實現中藥產業穩定成長的目的。本計畫釐清管理架構，整合行政法律資源，由具法學及藥學執業實務背景之研究人員組織「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，並整理彙編法務部及司法院有關中藥之法規資訊、司法判解、判解函釋及裁判書等相關法律資料，以及自民國60年衛生署成立以來之衛生署及中醫藥委員會所發布之中藥管理相關法律、法規命令、行政規章及解釋令函等資料，依法規名稱、法規內容、判解年度、函釋字號等，分類設計程式，納入蒐尋機制，製作「中藥法規整合資料庫」，發送中藥機構學校團體，並架設至中醫藥委員會及中華民國藥師公會全國聯合會網頁資訊平台，提供各界上網查詢及更新。並依中藥產品製造、輸入、流通、調劑、管理、消費行為與責任分配等事項，研擬管理流程與架構，擬議各中藥相關法律之修正條文草案，邀集中藥業界、中藥相關學系及法學等專家學者研討後，整合法律見解，依照立法格式，擬具因應相關法律條文內容，提供政府政策參考。另並請相關產業、公協會及學校研究機構，推薦適當之產官學研有關中藥科技及法規專業人才，建立「中藥科技及法規人才資料庫」，納入資訊平台，提供政府及業界諮詢。
關鍵字：中藥法規；法政諮詢；中藥法規整合資料庫

Study on the reorganization and establishment of databank on regulations of Chinese medicines

The aim of this study is to establish good management and guidance mechanism of the traditional Chinese medicine （TCM）industry through the reorganization of the regulations so that the steadily growth of the TCM industry can be reached.In this study, differentiating the management framework, integrating administrative law resources, organizing the task force of law and policy-making consultation of Traditional Chinese Medicine from different background have been conducted. The task force discussed on the legal cases that Committee of Chinese Medicine and Pharmacy handed in every month. 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. Furthermore, in this study the regulations, interpretations, commentaries, mandates and court verdicts of Ministry of Justice and the Judicial Yuan, and the relevant laws, regulations, administrative rules of Department of Health and Committee of Chinese Medicine and Pharmacy since 1971 have been put in order. The information has been sorted in accordance with regulation name, regulation content, year of announcement, classification and design formula, and brought them into searching mechanism, thus the 「Integrated Data Bank of regulations of Traditional Chinese Medicine」 has been established and subsequently distributed to schools and associations relevant of TCM .
關鍵字：regulations of herbal medicine；consultation of regulation and policy-making；Integrated Data Bank of regulations of Traditional Chinese Medicine