This multi-country study involved only ten countries out of the 191 WHO Member States (5%). In addition, the ten countries included in the study represented different levels of industrial, economic and social development as well as different political (government) systems which made comparison between countries in the development and implementation of drug regulation difficult. Despite these limitations, however, the study has enabled the identification of some of the difficulties that national regulatory authorities, particularly those in the developing world, face in ensuring the safety, quality and efficacy of drugs. It has also provided some examples of strategies that countries in the developed and developing world use to promote effective drug regulation. It is believed that a similar study involving a bigger number of countries representing different levels of development would provide better opportunities to learn more about the strengths and weaknesses of drug regulatory authorities and the different strategies used to improve drug regulation performance. The data collection guide used in this study could therefore also serve as a useful tool for countries and organizations that would like to assess drug regulation performance.

Finally, this synthesis report is based on data collected during 1998-1999 and therefore will not reflect any changes that may have taken place since then.