- Mots-clés > Good Distribution Practices (GDP)
- Mots-clés > inspection
- Mots-clés > laboratories - pharmaceutical quality control
- Mots-clés > licensing
- Mots-clés > medicines registration
- Mots-clés > medicines regulation
- Mots-clés > National Medicines Regulatory Authority (NMRA)
- Mots-clés > pharmaceutical regulation
- Mots-clés > post marketing surveillance
- Mots-clés > regulatory institutional capacity
(2017; 33 pages)
Wolde A, Kagoya HR, Mazibuko GN, Sagwa E. 2017. SIAPS’ Technical Assistance to Strengthen Medicines Regulation in Namibia: 2011–2017 . 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.
SIAPS helped improve pharmaceutical product quality by building the capacity of the Namibia Medicines Regulatory Council (NMRC) to review medicine registration dossiers; inspect pharmaceutical manufacturing facilities and finished (imported) products at ports of entry and in the marketplace; to chemically test medicines compliance with established standards; and monitor overall compliance with applicable regulatory standards and norms. In addition, SIAPS supported MOHSS in strengthening the management and regulation of medical devices and support equipment in Namibia, and in revising the National Medicines Policy, a crucial of pharmaceutical regulation and governance. SIAPS supported the reconfiguration of the desk-top Pharmadex tool to a web-based application. In general, the six-year support of the SIAPS project to the NMRC contributed to the strengthening of this regulatory agency, which in turn, contributed to improvements in service delivery to the clients. The registration process improved, to decrease the long-standing backlog of dossiers; PMS ensured safety and quality of pharmaceuticals; and implementation of web-based Pharmadex provided a means for clients/applicants to upload applications and follow up the progress of dossier review, which reduced workload for NMRC staff. SIAPS provided continuous TA for the restructuring of the NMRC.