- Palabras clave > Good Distribution Practices (GDP)
- Palabras clave > Good Manufacturing Practices (GMP)
- Palabras clave > inspection
- Palabras clave > laboratories - pharmaceutical quality control
- Palabras clave > licensing
- Palabras clave > medicines registration
- Palabras clave > medicines regulation
- Palabras clave > National Medicines Regulatory Authority (NMRA)
- Palabras clave > pharmaceutical regulation
- Palabras clave > regulatory institutional capacity
(2014; 78 pages)
Anisfeld M, An L, Mbaziira N, Kagoya H, Sagwa E. 2014. Strengthening the Capacity of the Namibia Medicines Regulatory Council in the Regulation of Antiretroviral Medicines and Other Essential Pharmaceuticals in Namibia. Submitted to the US Agency for International Development by the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program. Arlington, VA: Management Sciences for Health.
In 2009, the US Agency for International Development (USAID)-funded Strengthening Pharmaceutical Systems (SPS) Program, implemented by Management Sciences for Health (MSH), conducted an assessment of the NMRC and compiled a report entitled Strengthening Pharmaceutical Regulatory Capacity in Namibia. The report described the structure and function of the NMRC, identified challenges in its operations, and provided recommendations for improvements in the NMRC’s processes. As part of a five-year strategic plan, several goals were outlined, which included: developing institutional capacity; adopting a risk-based model for registration; streamlining initial screening of dossiers, including bioequivalence evaluations; prioritizing regulatory activities to focus on in-country monitoring; implementing the use of the electronic tool (Pharmadex) for all medicine regulatory activities; developing capacity to cover veterinary, complementary, and biological products; implementing competitive salaries; hiring more technical and administrative staff; revising and updating regulations to address gaps; and implementing capacity building recommendations. Five years following this assessment, the SIAPS Program, which succeeded SPS, provided further technical assistance. SIAPS conducted a holistic follow-up review of the NMRC to establish what progress had been made during the intervening time period, and to reach agreement with the NMRC on how and where SIAPS should focus its attention to strengthen the capacity of the NMRC in the regulation of antiretroviral medicines and other essential pharmaceuticals in Namibia.