FRONTESPIZIO - Cooperazione Italiana allo Sviluppo

∞ The majority of countries have established a drug regulatory agency.∞ Countries at all income levels report the presence of extensive legal and regulatoryframeworks covering all aspects of the pharmaceutical sector.6. Using indicators to measure the pharmaceutical sector in Ethiopia 85Table 3. Legislation and regulation on registration of medicinesTable 3. Legislation and regulation on registration of medicines∞ • The The median median number number of drugs of drugs marketed marketed increases increases with with country country income income level. level.∞ • The The requirement requirement for for marketing marketing authorization authorization was was supported supported by by written written guidelines forregistrationguidelinesinforoverregistrationthree quartersin overof countries.three quarters of countries.∞ Low-income countries were more likely to require use of the WHO Certification Scheme on• Low-income countries were more likely to require use of the WHOthe Quality of Pharmaceutical Products Moving in International Commerce.Certification Scheme on the Quality of Pharmaceutical Products Moving in∞ The availability of information about drug registration on the Internet increasesInternational Commerce.dramatically with country income level.• The availability of information about drug registration on the Internet increases4. Site dramatically inspection with of country establishments income level. as requirement of Table licensingTable 4. Site inspection of establishments as requirement of licensing∞∞Most • Most countries countries inspect inspect importers, importers, manufacturers, manufacturers, distributors distributors and pharmacies. and pharmacies.is somewhat less frequent in low-income countries.Site inspection• Site inspection is somewhat less frequent in low-income countries.Table 5. Monitoring of adverse drug reactions (ADRs)