- 期刊
回顧及借鏡歐洲藥典
Retrospective and What We Learn from the European Pharmacopoeia
摘要
藥典提供藥品之品質標準與檢驗方法技術規範，作為各國藥品之管理依據。歐洲藥典除由歐洲藥典委員會 (European Pharmacopoeia Commission) 負責編修外，並由歐洲理事會下設之歐洲藥品品質與衛生保健局 (European Directorate for the Quality of Medicines & Healthcare, Council of Europe，簡稱EDQM) 歐洲藥典部辦理編修行政事務。本文介紹歐洲藥典編撰過程、重點及運作模式，提供編修模式參考；其中歐洲藥典成功之關鍵在於有諸多專家貢獻於藥典編修。藉由專家實際參與藥典編修活動，可瞭解國際編修重點與趨勢，以利中華藥典編修現代化及加速國際協和化。近年來EDQM 負責業務逐漸多元化，除負責藥品品質標準之制定外，也加入化粧品、食品接觸材質、輸血、器官移植及藥事照護等業務。臺灣可透過參加化粧品、食品接觸材質等國際交流活動，了解國際上對此兩類產品管理概況及檢驗研究趨勢。
並列摘要
Pharmacopoeia provides the quality standards for pharmaceutical products, technical specification of testing methods and the basis of pharmaceutical management. The European Directorate for the Quality of Medicines & HealthCare (EDQM), the Council of Europe publishes the European Pharmacopoeia, and the European Pharmacopoeia Department of EDQM is responsible for the Secretariat of the European Pharmacopoeia Commission and for preparing the General Chapters and Monographs of the European Pharmacopoeia with the groups of experts. This article reviews the procedure of elaboration, concerns and operation of the European Pharmacopoeia, which can be used as a reference for the elaboration of the Chinese Pharmacopoeia. The key to success of the European Pharmacopoeia lies in the involvement and contribution of experts. Experts participate in the elaborating work, which comply with the international pharmacopoeia trends, in order to facilitate the modernization of the Chinese Pharmacopoeia and accelerate international pharmacopoeia harmonization. In addition to standardization of pharmaceutical quality, EDQM is also in charge of other activities, such as safety cosmetic products, food contact materials, blood transfusion, organ transplantation and pharmaceutical healthcare. By joining international activities on regulatory aspects, we are able to keep up with the mainstream of regulatory progress on the cosmetics and food contact materials products.
延伸閱讀
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