Drug Quality and Registration (DruQuaR) group
Ottergemsesteenweg 460, 9000 Ghent (Belgium)
Phone.: + 32 (0)9 264.81.01
Fax: + 32 (0)9 264.81.93
Title: Anti-malaria drugs in Ethiopia: Pharmaceutical regulatory frame and
High quality anti-malarial drugs should be accessible to the community in developing countries in general and Ethiopia in particular to control malaria-related mortality and morbidity. One of the objectives of this research project is to evaluate the regulatory approval process in Ethiopia, a factor which is responsible for availability and accessibility of high quality anti-malarial drugs: a SWOT risk-based analysis (legal frame, comparison with other developing countries, WHO/ICH- support/links, pharmaceutical responsibilities, risks evaluation, market-situation, post-approval controls, etc.) Additionally we want to evaluate the distribution chain of anti-malarial drugs in Ethiopia to intercept substandard and counterfeit drugs (legal frame, storage, traceability systems, logistics system, storage situation, etc.). The second objective is a pharmaceutical quality and information-content evaluation of anti- malarial drugs (Identity, assay, impurities, dissolution, and consistency): we will establish rational specifications for unidentified, not yet toxicity/efficacy characterized impurities, as well as develop QC methods.