OBJECTIVES: To systematically identify and compare how generic  medications, as defined by FDA, WHO, EMA,  are classified and defined by regulatory agencies around the world.  METHODS: We focused on emerging markets and excluded developed countries. For country selection, we identified the 3 most populace countries in each of the WHO regions: Africa, Americas, Eastern Mediterranean, Europe, South-East Asia and Western Pacific.  A systematic review of the published literature was performed through December 2012. Direct information from regulatory agencies and Ministries of Heath for each of the countries was extracted. Additionally, key informant interviews were performed for validation purposes. RESULTS: Of the 18 countries selected, only 50% provided an official country level definition for Generic drugs. The other 50% were comprised of those devoid of any definition and those that refer to the WHO definition of generics. Most countries acknowledge some form of Generic Drug Policy following the WHO framework.  However, only 65% have specific requirements for Generic drugs. The requirements are often associated with clinically viable therapeutic interchangeability. Most countries with requirements mention Bioequivalence but few require Bioavailability explicitly. At least one third of the countries have other terms in their definitions and processes that could be associated with Generics. In countries with Generic Drug Policies there is reference to patent or protection during the Drug Registration Process.  Lack of patent protection enforcement appears to hinder Generic drug production and utilization despite the existence of incentives for the use of Generics. 20% of countries do not mention Good Manufacturing Practices as part of the evaluation process. Countries in Africa and Eastern Mediterranean Regions appear to have a less developed regulatory framework. CONCLUSIONS: There is significant variability in the definition and classification of generic drugs in emerging markets.  Standardization of the definitions is necessary to make international comparisons viable.