Society’s control of the use of medicines, and of those who dispense and prescribe them, dates back several thousand years. Equally, norms, standards, practical guides and guidelines to promote effective regulation have now existed nationally and globally for several hundred years. Both developed and developing countries have practised drug regulation for some time.

WHO and other international agencies, nongovernmental organizations and donor agencies provide support for countries to supplement national efforts. However, despite the efforts made, less than 20% of WHO Member States are thought to have a well developed drug regulation system. Those which do are industrialized countries. Of the remaining Member States, about 50% implement drug regulation at varying levels of development and operational capacity. The remaining 30% either have no DRA in place, or have only a very limited capacity which barely functions at all (15).

Generally, in most developing countries, drug regulation is very weak, and the safety, efficacy and quality of imported or locally manufactured drugs cannot, therefore, be assured. Studies carried out in some countries show that about 20% of tested drug products fail to meet quality standards. Reports have also shown that the prevalence of substandard and counterfeit drugs is higher in countries where drug regulation is ineffective.

WHO has never undertaken a systematic assessment to identify the reasons for ineffective drug regulation and determine why so few Member States have succeeded in establishing effective drug regulation. The aim of this multicountry study is to assess drug regulation performances in selected countries using a standardized study guide, and to document the results so that other countries may learn from them.