建立中醫藥法規諮詢平台，規劃中醫藥法規制度

陳憲堂
中華民國藥事品質改革協會
本計畫目的為維護民眾中藥使用安全，建置有效的法規諮詢系統及作業平台，配合中醫藥有利發展的條件，研擬適合中醫藥環境之管理機制及法規。本計畫整合行政及法律資源，由具醫藥實務經驗之執業律師、法學教授及專業人員，組織「中醫藥法規諮詢小組」，建立中醫藥法規諮詢平台，就中醫藥委員會所交議之各項法規案件，及業界所提出中醫藥之各項法律問題，提供法律見解及諮詢服務，並彙編提供各相關公、學、協會參考。本計畫並檢視各項有關中醫藥之行政規章及解釋令函，蒐集、整理世界衛生組織、美國、歐盟、日本及中國大陸有關中醫藥法律規章，就中醫藥組織變革、中藥產品分類分級使用管理機制、與國際接軌之法規協合等方向，研擬適當法律位階之中醫藥管理法規及修正方向，提供中醫藥委員會作政策參考。另就中藥採輻射滅菌方式應行管理之相關法規內容，問卷調查分析產、官、醫、研各界之看法及意見，草擬「中藥輻射滅菌管制準則」草案及因應法律授權之藥事法修正草案，邀集中醫、藥學、法學專家學者、消費者團體及相關公、學、協會等共同座談研討後，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：用藥安全、法規諮詢、輻射滅菌

Study on making a regulation consulting platform and reorganizing regulations on Chinese medicines

Hsien-Tang Chen
Quality Improvement for Pharmaceutical Affairs Association, Taiwan
The purpose of this project is to maintain the safety for the Chinese medicine usage, to build an effective regulatory advisory system and operating platform to support the favorable conditions for development of Chinese medicine, and to develop appropriate management mechanisms and regulations. This project integrates the administrative and legal resources, forming a task force of consultation regarding regulations of TCM from different backgrounds including medical, pharmaceutical and legislation specialists. The task force offers legal opinions and consulting corresponding to legal cases that CCMP submits and legal issues related to TCM that proposed by the industry. In this study, we will collect and sort out the TCM regulations and explanations of the USA, European Union, Japan and Mainland China. Appropriate regulations and amendment will be proposed for policy-making reference based on the organization reform, categorized/graded applications of products, and harmonization of international regulations.
A questionnaire survey for industrial, government, medical, and research opinions regarding radiative sterilization for Chinese medicine related regulations will be held. The draft of guideline for management of radiative sterilization for Chinese medicine and the related draft amendments to the Pharmaceutical Affairs Law will be established and be reviewed in a public seminar involved with Chinese medical, pharmaceutical, legislation experts. The draft amendment clauses will be formulated and then made recommendations to CCMP.
關鍵字：safety medicine usage, regulation consulting ,radiative sterilization