Conclusions related to regulatory structures

If the purpose of dmg regulation is to promote public health and protect the public from harmful and dubious dmgs, it should cover all products for which medicinal claims are made and all activities associated with the manufacture, importation, distribution, dispensing and promotion of dmgs. 

This study has found that dmg regulation does not meet these requirements in all the countries studied. In some countries, legislation omits or exempts certain areas of pharmaceutical activity from the scope of control. In Australia, Malaysia and the Netherlands, legislation requires traditional/herbal medicines to be assessed and registered. But this is not the case in Cypms, Uganda or Zimbabwe. As a result of such gaps, dmg regulation provides only partial protection for consumers. 

While delegation of regulatory authority is found in all types of government, it is most far-reaching in countries with a federal system. Usually, full authority is delegated from the federal or central level to the states. If this is not properly coordinated, there will be problems of accountability. Such arrangements can also affect the national authority s 

Such a problem is not necessarily inevitable in federal-state delegation of authority. Mechanisms exist in some countries which can provide a link in the line of command and control. In Malaysia, the chief officer of the state regulatory authority is also a member of the federal-level organization. Policy communications between the federal and state levels, such as reporting, thereby become a routine. 

Standards and guidelines should be established in written form for all dmg regulatory functions. These tools should then be used to guide regulation practice, as well as being made publicly available in order to ensure the transparency of the dmg regulatory process. 

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