西藥製劑廠使用自用原料之現況調查

Survey on the Usage of Active Pharmaceutical Ingredients by Modern Pharmaceutical Manufacturers

陳惠玲(Hui-Ling Chen) ； 王澤民(Tse-Min Wang) ； 陳志維(Chih-Wei Chen) ； 陳映樺(Ying-Hua Chen) ； 黃琴喨(Chyn-Lian Huang) ； 陳惠芳(Hwei-Fang Cheng)

《食品藥物研究年報》 2期 (2011/12) Pp. 40-44

https://doi.org/10.6945/ARFDR.201112.0042

摘要

我國在推動西藥製劑廠實施GMP初期，為鼓勵製劑廠符合GMP標準及提升國內藥品之研究與發展，開放自用原料進口，以解決部分因原料使用量少，不易取得國外原料藥廠代理權的問題，此項措施大大促進了國內製藥產業發展。鑑於近年來偽劣藥品的猖獗，行政院民國99年9月20日「加強取締偽劣假藥及非法廣播電台」專案第25次會議決議，為杜絕偽劣假藥源頭、打擊不法，將加強查核西藥製劑廠自用原料之使用情形，以防止原料藥流入不法之用途。本報告即為查核我國西藥製劑廠使用自用原料之現況調查，並將結果提供作為制訂原料藥管理政策之參考。自99年11月起配合GMP後續查核西藥製劑廠，同時進行99年1至4季申請之自用原料使用情形查核，至100年4月30日止，查核25家製劑廠共757筆自用原料品項，發現148筆品項尚有缺失（佔19.6%），顯示自用原料應加強管理，現階段以建全自用原料申請與使用之回饋機制、加強代理商管理等，並配合PIC／S GMP國際標準之全面實施、原料藥GMP之執行以及藥事法的修訂等措施，加強自用原料管理，以保障民眾用藥安全。

關鍵字

GMP ； 自用原料 ； 西藥製劑廠

並列摘要

In the initial stage of promoting the implementation of GMP for modern pharmaceutical products in Taiwan, for the purpose of encouraging manufactures to comply with the GMP standards and improving the research and development in domestic medicine, the importation of raw materials for private use was open to solve the dilemma of the difficulty to gain franchise agreement from manufactures of certain less-use materials in other countries. This measure really did enhance the growth of the pharmaceutical industry in Taiwan. In view of rampant situation of counterfeit and inferior drugs recently, the Executive Yuan convened the 25(superscript th) session of ”Strength on cracking down on the counterfeit/inferior drugs and illegal radio stations” on 29 September, 2010 and passed a resolution of ”Block Source and Ban Illegality”. In order to block the source of counterfeit and inferior drugs, inspection on raw materials used by modern pharmaceutical manufacturers will be reinforced to prevent the raw materials from being used illegally. This report is a research about the inspection on raw materials usage of modern pharmaceutical manufacturers. Since November 2010, in order to cooperate with the follow-up GMP inspection of modern pharmaceutical manufacturers, the inspections of using raw materials by modern pharmaceutical manufacturers during 1 to 4 seasons in 2010 were conducted at the same time. Until April, 2011, 148 items in a total of 757 items of 25 inspected manufacturers were found to have deficiencies. It indicated that raw materials should be managed with more attention, at the present stage, by developing the feedback system on the application and usage of raw materials, reinforcing the management of agents, implementing the high standard PIC/S GMP in the future, implementing GMP on raw materials and amending Pharmaceutical Affairs Act, to protect the safety of public drug usage.

並列關鍵字

GMP ； PIC/S GMP ； modern pharmaceutical manufactures