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CCMP102-RD-013 健全中醫藥管理體制與法規環境(2-1)

  • 資料來源:中醫藥司
  • 建檔日期:102-09-26
  • 更新時間:111-02-14

陳憲堂、余萬能、許君薇 中華民國藥事品質改革協會 

本計畫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,建構中醫藥衛生產業發展優勢環境,提昇中醫藥產業之全球競爭力。本計畫組織「中醫藥法規諮詢小組」,建置法規諮詢作業平台,由具醫藥實務經驗之執業律師、法學教授及專業人員,就中醫藥委員會所交議及業界所提出有關中醫藥之各項法律問題,提供法律見解及諮詢服務,並分類彙編,提供政策及執行參考。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,研擬藥事法及其子法規修正草案及適當法律位階之中醫藥管理法規,提供中醫藥委員會作政策參考。 

關鍵字:管理體制、法規諮詢、組織變革、法規協合 

Study on building an intact management system and regulatory environment for Chinese medicines (2-1) Hsien-tang Chen, Wan-nan Yu and Chun-wei Shu Quality Improvement for Pharmaceutical Affairs Association, Taiwan The purpose of this project is to maintain the safety for the Chinese medicine usage through an effective regulatory advisory system and construct a predominant environment following the enhancement of the global competitiveness for the Chinese medicine industry. A task force of consultation regarding regulations of TCM from different backgrounds including medical, pharmaceutical and legislation specialists is formed and 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 regulations and explanations related to TCM of Taiwan and TCM regulations of the USA, European Union, Japan and Mainland China. Appropriate regulations and amendment will be proposed to CCMP for policy-making reference based on the organization reform, categorized/graded applications of products, and harmonization of international regulations.