Project rationale and development

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 dmg regulation for some time. 

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

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

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