藥品優良製造規範之法制及實務問題【月旦時論】 試閱
Legal and Practical Issues Related to GMP for Pharmaceutical Products
藥品優良製造規範(GMP)以系統化管理嚴格控制整個藥品製造生產流程，排除影響藥品品質之可能風險，係為確保病人使用安全及療效之行政目的，中西藥品之性質迥異，製造管理之強度及密度亦有不同。邇來，常見中西藥廠違反GMP之規定，該當「藥事法」所定行政罰，惟主管機關認為亦應該當同法未經核准擅自製造之偽藥罪。本文乃就GMP規範目的，探討藥廠違反GMP事件之原因及態樣，並如何適用法條究其行政及刑事責任，供主管機關審酌參考。
Good Manufacturing Practices (GMP) systematically manages and strictly controls the entire pharmaceutical manufacturing process to eliminate potential risks affecting drug quality. Recently, violations of GMP regulations by both Chinese and Western pharmaceutical manufacturers have become commonplace, which should be warrant administrative penalties under the Pharmaceutical Affairs Law, While such violations, competent authorities believe that it should also be considered the crime of manufacturing counterfeit drugs without approval under the same law. This article discusses the causes and patterns of GMP violations, as well as how to investigate their administrative and criminal responsibilities for the purpose of GMP regulations, for the reference of the competent authorities.
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