Organization Act of the Food and Drug Administration, Ministry of Health and Welfare Article 2
The Administration shall be in charge of following matters:1. Drafting and implementing management policiesand regulations of food, human drugs, medical devices and cosmetics (hereinafter referred to as "food, drugs and cosmetics”).2. Examination and registration, review and market approval, licensing and filing for reference of food, drugs and cosmetics;supervision and review human trials of drugs.3. Management of the production process, import testing/inspection, circulation, inspection, examination, and guidance of food, drugs and cosmetics manufacturers.4. Analysis, research, laboratory accreditation, risk assessment and riskmanagement of food, drugs and cosmetics, and analysis of Chinese medicines and herb.5. Safety surveillance of food, drugs and cosmetics, and investigation and management of hazard events.6. Inspection, reporting, alerting, and abuse prevention and education of controlled drugs. Import, export, manufacture and sale of Schedule 1 and Schedule 2 controlled drugs.7. Promotion of consumer protection measures relating to food, drugs and cosmetics.8. International cooperation and management prior to import of food, drugs and cosmetics.9. Other relevant administrativematters of Food and Drug cosmetics.
中文原文 衛生福利部食品藥物管理署組織法第2條
本署掌理下列事項:
一、食品、藥物、化粧品(以下簡稱食品藥物化粧品)管理政策之規劃與執行及相關法規之研擬。
二、食品藥物化粧品之查驗登記、審核、給證、備查與藥物人體試驗之審查及監督。
三、食品藥物化粧品業者之生產流程管理、輸入查(檢)驗、流通、稽查、查核及輔導。
四、食品藥物化粧品之檢驗、研究、實驗室認證、風險評估與風險管理及中藥、植物性藥材之檢驗。
五、食品藥物化粧品之安全監視、危害事件調查及處理。
六、管制藥品之稽核、通報、預警、教育宣導與第一級、第二級管制藥品之輸入、輸出、製造及販賣。
七、食品藥物化粧品消費者保護措施之推動。
八、食品藥物化粧品事務之國際合作及境外管理作業。
九、其他有關食品藥物化粧品之管理事項。
一、食品、藥物、化粧品(以下簡稱食品藥物化粧品)管理政策之規劃與執行及相關法規之研擬。
二、食品藥物化粧品之查驗登記、審核、給證、備查與藥物人體試驗之審查及監督。
三、食品藥物化粧品業者之生產流程管理、輸入查(檢)驗、流通、稽查、查核及輔導。
四、食品藥物化粧品之檢驗、研究、實驗室認證、風險評估與風險管理及中藥、植物性藥材之檢驗。
五、食品藥物化粧品之安全監視、危害事件調查及處理。
六、管制藥品之稽核、通報、預警、教育宣導與第一級、第二級管制藥品之輸入、輸出、製造及販賣。
七、食品藥物化粧品消費者保護措施之推動。
八、食品藥物化粧品事務之國際合作及境外管理作業。
九、其他有關食品藥物化粧品之管理事項。