OBJECTIVES: Globalization of pharmaceutical industry has made many new drugs available in the world.   In response to the many withdrawals of high profile drugs like Vioxx® and Baycol®, the United States and European Union have proposed the reform or more regulations and guidance related to drug safety surveillance for pharmaceutical industry.   It is critical about drug safety in large population because adverse drug events (ADE) and treatment failures are related to sizable economic costs.   We proposed to review the current status of drug safety surveillance in developing countries and to compare it with some developed countries. METHODS:  This paper sets out to explore the nature of regulatory systems and review government sponsored Spontaneous Reporting System for ADE in different developing countries. Then we would compare their drug safety surveillance systems with developed countries.  Because the World Health Organization (WHO) has a program for drug monitoring (Uppsala Monitoring Center), we will focus on some WHO member countries and regions.  Data will be primarily retrieved by extensive literature review.   RESULTS:  Based on preliminary data, developing countries like China, Malaysia, and India have relevant regulatory agencies for drug safety surveillance that collect and maintain reports of potential ADEs.  Developing countries are usually lagging way behind in terms of ADE reporting and detection.  Different tools are used within some individual countries.  There is a definite need for drug safety programs in the developing countries given the fact that the developing countries differ markedly in terms of type of disease prevalence, patient genotype and environment.  CONCLUSIONS:  Detailed information on drug safety surveillance in the developing countries would help understand the deficiencies in the current surveillance programs and may serve as a guide for pharmaceutical industry in these countries.