- Todos > Quality and Safety: Medicines > Counterfeit Medicines
- Todos > Quality and Safety: Medicines > Quality Assurance
- Todos > Quality and Safety: Medicines > Regulatory Support
- Todos > Quality and Safety: Medicines > Safety and Efficacy
- Palabras clave > access to antiretrovirals (ARVs)
- Palabras clave > adverse drug reactions (ADRs)
- Palabras clave > efficacy and safety of medicines
- Palabras clave > HIV/AIDS-related drugs
- Palabras clave > medicines registration
- Palabras clave > post marketing surveillance
- Palabras clave > quality assurance of antiretrovirals
- Palabras clave > sampling and testing - medicines
- Palabras clave > substandard/spurious/falsely-labelled/falsified/counterfeit medicines (SSFFC)
(2016; 18 pages)
Mbaziira N, Kagoya HR. 2016. Quality and Safety of HIV/AIDS Medicines in Namibia October 2015-September 2016. 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 the last five years, SIAPS has provided technical assistance to the Namibia Medicines Regulatory Council (NMRC) to strengthen its capacity for registration and quality testing by training technical staff in medicines dossier evaluation, developing guidelines for conducting the routine PMS of quality of medicines, and collecting medicine samples at selected ART and TB treatment sites for laboratory testing. SIAPS mentored and provided guidance and technical support to NMRC staff and other personnel in conducting efficient dossier reviews for the registration of ARVs, anti-TB, and other essential medicines. Consequently, intensive dossier review sessions were organized and fully funded by NMRC after effective and successful transition of the activity to NMRC for sustainability. SIAPS provided technical assistance to the NMRC to develop guidelines and collect medicine samples from seven priority regions (Kavango East and West, Khomas, Ohangwena, Omusati, Oshana, Oshikoto, and Zambezi) and one urban hotspot (Grootfontein [Otjozondjupa]).