Definition and Classification of Generic Drugs Across the World

Our aim was to systematically identify and
compare how generic medications, as defined by the US
Food and Drug Administration (FDA), World Health Organization
(WHO), and European Medicines Agency
(EMA), are classified and defined by regulatory agencies
around the world. We focused on emerging markets and
selected the most populated countries in each of the WHO
regions: Africa, the Americas, Eastern Mediterranean,
Europe, Southeast Asia, and Western Pacific. A structured
review of published literature was performed through December
2013. Direct information from regulatory agencies
and Ministries of Health for each country was extracted.
Additionally, key informant interviews were performed for
validation. Of the 21 countries selected, approximately half
provided an official country-level definition for generic
pharmaceuticals. The others did not have any definition or
referred to the WHO. Only two-thirds of the countries had
specific requirements for generic pharmaceuticals, often
associated with clinical interchangeability. Most countries
with requirements mention bioequivalence, but few required
bioavailability studies explicitly. Over 30 % of the
countries had other terms associated with generics in their
definitions and processes. In countries with generic drug
policies, there is reference to patent and/or data protection
during the drug registration process. Several 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. In summary, 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.