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Organization Act of the Food and Drug Administration, Ministry of Health and Welfare
1.中華民國九十八年六月三日總統華總一義字第 09800137391 號令制定 公布全文 10 條；施行日期，由行政院定之 中華民國九十八年十二月二十三日行政院院授研綜字第 0982261665 號 令發布定自九十九年一月一日施行 2.中華民國一百零二年六月十九日總統華總一義字第 10200113961 號令 修正公布名稱及全文 7 條；施行日期，由行政院以命令定之 （原名稱：行政院衛生署食品藥物管理局組織法；新名稱：衛生福利部 食品藥物管理署組織法） 中華民國一百零二年七月十日行政院院授研綜字第 1022260532 號令發 布定自一百零二年七月二十三日施行
資料來源：全國法規資料庫（ChLaw.json，版本 2026/7/24 上午 12:00:00）・政府資料開放授權
The Ministry of Health and Welfare shall establish the Food and Drug Administration (hereinafter referred to as "TFDA") to administer and examine food, human drugs, medical devices and cosmetics.
1The Administration shall be in charge of following matters:
21. Drafting and implementing management policiesand regulations of food, human drugs, medical devices and cosmetics (hereinafter referred to as "food, drugs and cosmetics”).
32. Examination and registration, review and market approval, licensing and filing for reference of food, drugs and cosmetics;supervision and review human trials of drugs.
43. Management of the production process, import testing/inspection, circulation, inspection, examination, and guidance of food, drugs and cosmetics manufacturers.
54. Analysis, research, laboratory accreditation, risk assessment and riskmanagement of food, drugs and cosmetics, and analysis of Chinese medicines and herb.
65. Safety surveillance of food, drugs and cosmetics, and investigation and management of hazard events.
76. Inspection, reporting, alerting, and abuse prevention and education of controlled drugs. Import, export, manufacture and sale of Schedule 1 and Schedule 2 controlled drugs.
87. Promotion of consumer protection measures relating to food, drugs and cosmetics.
98. International cooperation and management prior to import of food, drugs and cosmetics.
109. Other relevant administrativematters of Food and Drug cosmetics.
1The Administration shall have one director-general at senior grade 13; two deputy directors-general at senior grade 12.
2If deemed necessary, the director-general and one of the deputies directors-general in the preceding paragraph may be a medical person of Senior Grade 1 in accordance with regulations of the Medical Personnel Management Act.
The Administration shall have a chief secretary at senior grade 11.
The Administration can have research fellows and associate research fellows, who, if deemed necessary, may be appointed in accordance with the relevant regulations of the Statute Governing the Appointment of Educators. The retirement benefits and compensation for the research fellows and associate research fellows shall accord to the provisions enacted for teachers, subject to the approval of the Ministry of Health and Welfare
One of director or deputy director of each division and one-fifth of the total number of senior specialists, if deemed necessary, may be a medical person of Senior Grade 1 in accordance with regulations of the Medical Personnel Management Act. The civil servant qualifications, ranks, and quota for all positions of the Administration shall be set forth separately in an organizational chart.
The date of implementation of the Act shall be determined by the Executive Yuan.