西藥製劑廠使用自用原料之現況調查（II）

鑑於近年來偽劣藥品的猖獗，行政院為杜絕偽劣假藥源頭、打擊不法，於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，針對西藥製劑廠自用原料加強查核，了解我國西藥製劑廠使用自用原料之現況，以防止原料藥流入不法之用途，本報告係延續去年所發表之「西藥製劑廠使用自用原料之現況調查」（99年11月至100年4月間查核結果），另新增100年度之調查結果一併討論。本局自99年11月起配合GMP後續查核西藥製劑廠，進行99至100年申請之自用原料的使用情形查核。99年申請案中，已查核60家藥廠，其中47家（78.3%）自用原料使用情形尚有缺失；100年申請案中，已查核44家藥廠，其中28家（63.6%）自用原料使用情形尚有缺失，顯示西藥製劑廠自用原料之管理應有再加強之必要。現階段以健全自用原料申請與使用之回饋機制，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，強化自用原料藥管理，以保障民眾用藥安全。

關鍵字

自用原料；西藥製劑廠

並列摘要

In view of rampant situation of counterfeit and inferior drugs recently, the Executive Yuan convened the 25th session of ”Strength on cracking down on the counterfeit/inferior drugs and illegal radio stations” on September 29th, 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.Since November 2010, in order to cooperate with the follow-up GMP inspection of modern pharmaceutical manufacturers, the inspections of raw materials usage by modern pharmaceutical manufacturers during 2010 to 2011 were conducted at the same time. Forty-seven were found to have deficiencies in a total of 66 inspected manufacturers in 2010, and 28 in a total of 44 in 2011. 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 ； raw materials ； modern pharmaceutical manufactures

國際替代計量

西藥製劑廠使用自用原料之現況調查（II）

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