The World Health Organization and pharmaceutical experts have recommended that
Generic Drug Policies be implemented to improve the availability of affordable medicines. This
document reports on the status of generic drug policies in Latin America. The data presented are
based on several sources: a survey conducted in 2003, archival information, and official health
and pharmaceutical policy documents. The survey revealed that countries use different
definitions for the terms “generic and bioequivalence” severely curtailing the ability to make
comparisons across countries. There is also ample variability in the periods allowed for drug
registration and registration charges. Although most countries in the region are becoming
increasingly dependent on pharmaceutical imports, many have sizeable local pharmaceutical
manufacturing capacity. The need to adopt common definitions for technical terms, the urgency
of improving quality controls and the importance of strengthening generic drug programs are
highlighted.