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 |