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