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Appendix C Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China 273

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Director: Food Control 274 Secretary Sub Directorate: Chemical Safety Sub Directorate: Biological Safety Sub Directorate: Integrity Liaison Senior Administrative Deputy Director: Additives, and Programme Support Deputy and Regulatory Nutrition Deputy O cer contaminants, biotechnology, Director: Food imports; MHS; lab Director: National Codex O ce, residue’s, etc. analysis; food safety alerts, etc. food labeling, etc. Chief Clerk Assistant Director: Food Assistant Director: Food hygiene, Assistant Director: Regulatory biotechnology, ADIs, residue limits, HACCP, food microbiological nutritional Senior Administrative classification of pesticides standards Clerk Assistant Director: Food additives Assistant Director: Information, Senior medical natural scientist: Senior Registry Clerk and contaminants, standards, and education, and communication Labeling ingredients and non-nutritional programmes; food surveillance labeling and monitoring programs Senior medical natural scientist: Senior Administrative O cer Contaminants FIGURE C-1 Organization of the South African Food Control Directorate. SOURCE: South African Food Control Directorate.

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Minister Ministry Strategic Judicial Executive Subsecretary Ombudsman Cabinet Advisory consultancy Secretary of planning and Board administration Department Secretary of Secretary of Secretary of Agribusiness Executive planning National of Agricultural Agricultural Agricultural Bioenergy international committee for Institute of Defense Development Policy Production relations cocoa crop Meteorology and Cooperation National agricultural Federal superintendent of agriculture, laboratories livestock, and food provisions National Horse Breeding Special committee Deliberative council National Council Coordination Commission for resources for co ee policy for Agricultural Policy National Supply Brazilian Agricultural Company Research Company Semi-public enterprise Semi-public enterprise São Paulo Central Warehouses (food for food distribution for food storage distribution, commercialization, and storage) FIGURE C-2 275 Organization of the Brazilian food regulatory system.

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276 Ministry of Health and Family Welfare Ministry of Agriculture Ministry of Commerce and Industry Food Safety and Standards Authority of India Directorate of Plant Protection, Quarantine Agriculture and Processed Food Products (FSSAI) an independent statutory authority and Storage Export Development Authority • Processed foods • Domestic and imported produce • Export of fresh and processed fruits and vegetables, cereals, organic • Food safety for domestic, imported, fresh, Department of Animal Husbandry, Dairy and processed foods and Fishery Export Inspection Council (EIC) of India • Animal products • Pre-shipment inspection and certification by Export Inspection Authority (EIA)/ Food Laboratories for notified commodities such as fish, honey, egg, and milk products Import Export Inspection Inspection FIGURE C-3 Organization of Indian food regulation. SOURCE: USDA.

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Coordinator Leading Group of State Council: Committee on Product Quality and Food Safety Coordinates government agencies on development of laws and legislation Pillars of General Administration Ministry of Health Ministry of Agriculture State Administration for the food of Quality Supervision, Industry and Commerce Coordinates domestic food Supervises all agriculture inspection Inspection and Quarantine safety and inspection and animal husbandry Inspects markets: responsible Inspects whole production for consumer protection and business licensing General Certification and State Food and Drug Accreditation Administration Administration Sets plans for implementa- Inspects foods and food tion of accreditation service establishments General Administration Chinese Centers for Disease of Customs Control and Prevention Inspects all imports and Public health management exports and handles for food safety quarantine and clearance Provincial and City CDCs Local public health management for food Other National Development and Ministry of Environmental Ministry of Railways and Ministry of Science and important Reform Commission Protection Transportation Technology food safety Plans and develops policy to Supervises environmental Regulates logistics of food Coordinates scientific agencies regulate the food industry aspects of agriculture production transportation research to inform policy FIGURE C-4 Organization of Chinese food regulatory system. 277 SOURCE: Broughton and Walker, 2010.

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Cluster: Medicines Regulatory A airs 278 Registrar of Medicines Technical Services & O ce Management Directorate Directorate Directorate Directorate Operations & Administration Inspectorate & Law Enforcement Clinical Evaluation & Trials Medicine Evaluation & Research Finance CDCC Inspectorate Law Enforce- Clinical Unit Clinical Trials Pharmaceutical Pharmaceutical Deputy ment Deputy Analytical Analytical Director Director Pre-Registra- Post-Registra- tion Deputy tion Deputy Pharmacovigilance Director Director Complementary and ATM FIGURE C-5 Organization of South African medical product regulatory system. SOURCE: Government of South Africa.

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Collegiate Ombudsman1 board Consulting Council1 General Director Cabinet Attorney Corregidor2 Audit Planning Institutional Advisory security advisory Coordination with International Economic advisory Postmarket notification and national Education, research, state agencies A airs in regulation research in health surveillance and knowledge Administration Human Information and Finance Resources Technology Foods API, prod- Medicines Sanitizing Technology in Medical Cosmetics ucts, drugs products health services devices Public Health Ports, airports Blood, other tissues, Toxicology Advertising, promotion, and Laboratories and borders cells and organs information of health products Tobacco products FIGURE C-6 Organization of the Brazilian medical product regulatory system, ANVISA SOURCE: ANVISA Notes: 1. The ombudsman and consulting council are not subordinate to the collegiate board. 279 2. The Corregidor enforces laws and regulations within Anvisa.

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280 Drugs Controller General Headquarter Zonal Office (4) Sub Zonal Office (2) Post Office (7) Laboratory (6) • New Drugs • GMP Audits • GMP Audits • Import • Testing with drug samples • CLAA • Coordinates with • Coordinates with • Export States States • Validation of • Imports test protocol • DTAB/DCC FIGURE C-7 Indian drug control system, the Central Drugs Standard Control Organization. SOURCE: Government of India.

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Commissioner Deputy Deputy Deputy Deputy Chief of Discipline Commissioner Commissioner Commissioner Commissioner Inspection Group General O ce Dept. of Policy Dept. of Dept. of Dept. of Drug Department Dept. of Drug Bureau of Dept. of Dept. of (Dept. of & Regulations Health Food Food Safety Registration of Medical Safety & Investigation Personnel International Planning and & Cosmetics Supervision (Dept. of Devices Inspection & Enforcement Cooperation Finance) TCMs & Eth- Supervision (O ce of no-Medicines Hong Kong, Supervision Macao & Tai- wan A airs) Division of Dept. of Policy Dept. of Health Dept. of Dept. of Drug Department Dept. of Drug Bureau of Dept. of Per- Dept. of General A airs & Regulations Food & Food Safety Registration of Medical Safety & Investigation & sonnel International (O ce of Let- Cosmetics Supervision (Dept. of Devices Super- Inspection Enforcement Cooperation Division of Division of ters and Calls) TCMs & Ethno- vision (O ce of Hong General Division of Division of Division of Division of General A airs Medicines Kong, Macao & Division I of A airs (O ce Food General A airs Division of General A airs General A airs Supervision) Taiwan A airs) Division of Secretaries of Admin. General A airs Division of Division Division Division I of Personnel and Reconsid- Division of Division of Division II of Health Food of Food Division I of of Drug Investigation & eration) General A airs International Division of Secretaries Supervision Registration Manufacturing Enforcement Organizations Division of Training Division of Division of TCM Supervision Division of Cosmetics Division of Division II of Division II of Regulations and Ethno- Division of Division of Emergency Monitoring and Registration Division of Investigation & Medicines European, Division of Salary Management Division of Evaluation Pharmaco- Enforcement Asian and Inspection Division of Policy Research Division of vigilance & African A airs Division of Manufacturing Division III of Pharmaceut- Reevaluation Archives O ce of News & Distribution Investigation & icals Division of Supervision Division of Enforcement American Division of Division of Controlled and Oceanian Development Division of Biological Drugs A airs & Planning Research and Products Supervision Reevaluation Division of Division of Budget Drug Research Management Supervision Division of Financial A airs FIGURE C-8 Chinese drug regulatory system, State Food and Drug Administration (SFDA). 281 SOURCE: SFDA, 2011.

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