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About FDA

Organization 【Date:2014-06-06】 unit:企劃及科技管理組

Orgranization Chart of TFDA
Food and Drug Administration products management-Pharmaceutical Management
Food and Drug Administration products management-Medical Device Management
Food and Drug Administration products management-Food Management
Food and Drug Administration products management-Cosmetics Management

Responsibilities of divisions (centers)

◇ Division of Planning and Research Development:
  1. Overall planning, management, and assessment of all TFDA’s business.
  2. Planning and promotion of policies and technology research projects relating to food, drugs, medical devices and cosmetics.
  3. International cooperation and exchange about food, drugs, medical devices and cosmetics.
  4. Legal affairs relating to food, drugs, medical devices and cosmetics.
  5. Promotion of consumer protection measures relating to food, drugs, medical devices and cosmetics.
Division of Food Safety:
  1. Planning of food safety and sanitation policies, regulations and management.
  2. Management of food labeling and food nutrient analysis.
  3. Registration, and certification of food products, food utensils, food containers, food packaging, and food addictive; review alteration, transfer, and extension of such certificates; issuing, renewing, and reissuing of such certificates.
  4. Planning of imported foods and related products management and policy promotion.
  5. Planning of food manufacturing process management and policy promotion.
  6. Planning and guidance of safety and sanitation policies and regulations on food business and food services.
  7. Other matters related to food management.
Division of Medicinal Products:
  1. Medicinal products management, consultation for industry, measures and regulation planning.
  2. Inspection, registration and market approval of medicinal products; review of alteration, transfer, and extension of drug permit licenses; issuing, renewing, and reissuing of drug permit licenses.
  3. Medicinal products safety surveillance, assessment, and drug injury relief.
  4. Reviewing, monitoring, and management of medicinal clinical trials.
  5. Medicinal products management for rare diseases and special urgent needs.
  6. Other matters related to medicinal products.
Division of Medical Devices and Cosmetics:
  1. Regulation, policy, and statute drafting of medical devices and cosmetics
  2. Review of medical devices and cosmetics registration, license amendment, transfer, and extension, and issuing, renewing, and reissuing of such licensing
  3. Safety surveillance, evaluation, and consultation assistance of medical devices and cosmetics
  4. Review and regulation of medical device human trials
  5. Regulation of medical devices for emergent uses
  6. Others matters related to regulation of medical devices and cosmetics
Division of Controlled Drugs:
  1. Management, policy and drafting statutes of controlled drugs.
  2. Reviewing and issuing certificates of use and registration of controlled drugs; issuing and management of such related approvals.
  3. Reviewing, filing, and managing claim forms of controlled drug flow.
  4. Education promotion, investigation, reporting, warning, and effect evaluation of controlled drugs.
  5. Supervised importing, exporting, manufacture and selling of controlled drugs schedule I and II.
  6. Others matters related to controlled drugs.
Division of Research and Analysis:
  1. Testing, research and evaluation for food, medicinal products and cosmetics.
  2. Establishment of specification and testing methods for food, medicinal products and cosmetics.
  3. Development of testing methods for emergency events.
  4. Technical support for the TFDA Regional Administration and local health bureaus.
Division of Risk Management:
  1. Organizational risk management, preparedness and response to emergency events.
  2. Planning, management, and execution of accreditation of food, drugs, medical devices and cosmetics laboratories.
  3. Planning, management, and enforcement of Good Manufacturing Practice inspection for pharmaceutical, medical devices, and food manufacturers.
  4. Planning, management and enforcement of Good Tissue Practice inspection for tissue banks and cellular therapies.
Centers for Regional Administration (Northern, Central, Southern):
  1. Planning, management, and execution of certification on port-of-entry inspection and laboratory testing of imported food, drugs, medical devices, controlled drugs and cosmetics.
  2. Planning, management, and execution of post-marketing inspection and laboratory testing of food, drugs, medical devices, controlled drugs and cosmetics.
  3. Coordinating and assisting local health authorities in related inspection and laboratory testing.
  4. Assisting local health authorities in consumer protection of food, drugs and cosmetics.
Factory for Controlled Drugs:
  1. Manufacturing, supplying, importing, exporting, and selling the Schedules I and II controlled drugs.