Globalisation of drug regulation and drug regulators in developing countries

Abstract

Drug regulatory agencies in developing countries are often relatively small and poorly funded; they are therefore necessarily heavily dependent upon the experience gained and the assessments carried out by larger national agencies elsewhere. This applies both to the basic efficacy/safety evaluation of new chemical entities and the quality evaluation of products based on well-known active components and also to other acts of major agencies, e.g., with respect to unexpected problems arising with a drug or the correction of inadmissible advertising. To date, far too little information on these matters is available to the agencies of developing countries. In part this is due to lack of formalised international arrangements, but the agencies which should be able to provide this information are also sometimes poorly structured to do so, and in some instances serious doubts exist as to the reliability of regulatory work carried out elsewhere, whether this relates to evaluation of drugs, inspection of manufacturing plants or other matters. These problems are often compounded by the fact that agencies in developing countries may have an insufficient legal infrastructure to carry out their task to the full.