The European Union
INTRODUCTION The generic drug product market is projected to grow from US $15 billion in 2004 to US $27 billion in 2009 in the United States, and from US $9 billion to US $14 billion in Western Europe (1). Moreover, the growth opportunities for generic drug products in the near future are significant with an estimated US $100 billion worth of branded pharmaceutical products to go off patent by 2010 (1). The substantial growth of the world generics drug market has been driven by a number of factors, but in particular the need to contain public health care spending, including the expenditure on drug products. In response to the important growth of the generic pharmaceutical industry during the last 10 to 15 years, regulatory agencies in countries all over the world, such as the Food and Drug Administration (FDA) in the United States, Canada’s Health Products and Food Branch (HPFB), and the European Medicines Agency (EMEA) in the European Union (EU), have established requirements which must be met by a generic drug product to receive marketing authorization (2,3).