ABSTRACT
BACKGROUND Much progress has been achieved over the last 50 years in the field of pharmaceuticals, both in terms of introducing new medicines and improving the regulation of medicines. This progress involves mostly highly industrialized countries where citizens can benefit from new innovative drugs and enjoy access to quality assured multisource (generic) medicines as well. Lack of access to quality essential drugs, the majority of which are multisource (generic) medicines, remains a serious health problem and global disequilibrium of quality continues to threaten patients in many parts of the world (1). The overall tendency is that resource-constrained or resource-poor countries are less likely to control the quality of products on the market, enjoy political support for the regulators, or have properly resourced and functioning regulatory authorities (2). It is no wonder that in many resource-poor settings patients do not trust locally authorized multisource (generic) products.
