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. 2024 Oct 16;4(10):e0003241. doi: 10.1371/journal.pgph.0003241

Table 4. Medicines regulatory capacity–Summary of findings.

1978 to 2002 2003 to 2020
Institution Pharmacy Board
* National Food Control Commission for food safety
• Pharmacy Council
• Tanzania Food, Drugs, and Cosmetics Act 2003
Organizational management and Level of autonomy • Executive Board in the Ministry of Health
• Supported by an administrative Secretariat.
• Centralized
• Headed by a Registrar
• Organized in four (4) sections
• Semi-autonomous Agency and Council.
• Headed by a Director General supported by six (6) units.
• Organized in four (4) directorates.
• HQ supported with seven (7) administrative zone offices.
• Registrar of the Pharmacy Council reports to the Chief Medical Officer at the Ministry of Health
• Director General of Tanzania Medicines and Medical Devices (TMDA) reports to the Permanent Secretary at the Ministry of Health
Resources Physical infrastructure
• One office building
Human
• Less than 30 staff.
Finance
• Government
Physical infrastructure
• TFDA/TMDA
• Multi-storey Office buildings Dar, Mwanza
• Laboratory Buildings Dar and Mwanza
Human
• More than 200 staff.
Finance
• Government
• Collection of fee and charges
• Development partners
Challenges Lack of autonomy/independence
• Limited human resources
• Limited technology
• Inadequate financial resources
• Lack of organizational capacity building

• Expansion in breath of regulatory domains
• Advancement in technology
• Low domestic production capacity