Pharmaceutical Affairs Act Enforcement Rules Article 4
The term "inspection" as used in the Act means the examination of matters in respect of whether a drug has undergone registration and market approval, and whether the drug conforms with the original market inspection and approval or other relevant provisions.The term "testing" as used in the Act means the chemical testing and assessment of the state, ingredients, quality, quantity, or strength of a drug, or the assessment of a medical device through chemical, physical, mechanical, or materials testing.
中文原文 藥事法施行細則第4條
本法所稱稽查，係指關於藥物有無經核准查驗登記及與原核准查驗登記或規定是否相符之檢查事項。
本法所稱檢驗，係指關於藥品之性狀、成分、質、量或強度等化驗鑑定事項，或醫療器材之化學、物理、機械、材質等鑑定事項。
本法所稱檢驗，係指關於藥品之性狀、成分、質、量或強度等化驗鑑定事項，或醫療器材之化學、物理、機械、材質等鑑定事項。