The discipline of pharmacovigilance is based on the reporting of a drug's adverse events. The regulatory authorities in the developed world, led by the Food and Drug Administration and the European Medicine Evaluation Agency, require pharmaceutical companies to report all adverse events related to their products wherever they operate and sell their products. However, in many developing countries, pharmacovigilance is not necessarily a national priority as there are other public health issues, and even when there is a regulatory requirement for adverse event reporting, the scarcity of resources and lack of enforcement might limit the magnitude of safety reporting. As part of globalization, pharmaceutical companies are operating in most of the world through their own local affiliates or through local agents. Therefore, the authors suggest that, as pharmaceutical companies apply the strictest pharmacovigilance practice all over the organization, they do so particularly in developing countries, raising awareness of safety reporting by providing financial incentives when conducting clinical trials or by providing the expertise and resources to train local professionals.
|Journal||Food and Drug Law Journal|
|State||Published - 11 Sep 2008|
ASJC Scopus subject areas
- Public Health, Environmental and Occupational Health