Comparison of the regulatory outline of ecopharmacovigilance of pharmaceuticals in Europe, USA, Japan and Australia

Abstract

Pharmaceuticals are known to improve the quality of life by curing and preventing diseases. However, these pharmaceutical products, when it diffuses through the environment by various routes, can cause severe harmful effects to the living organisms. During the last several years, the coping with the impact of pharmaceuticals on the environment was one of the challenging tasks for the pharmaceutical industries. These concerns about the environmental health and safety risks paved the way in developing a proper regulatory framework for environmental risk assessment of pharmaceutical products. In the US, EU, and Canada, most improvements have been made in the regulation of Environmental Risk Assessment (ERA) for pharmaceuticals. Many countries and organizations like the Organization for Economic Cooperation and Development (OECD), had adapted these ERA procedures to fulfil the purpose. At present, there are no specific guidelines for ERA of pharmaceuticals in Japan, Australia and many other countries. Nevertheless, it is expected that they will have strict regulations and legal requirements in the future. The purpose of this study is to understand and compare the ERA regulation in Europe, USA, Japan and Australia. In this review, we have summarized the knowledge on ERA of pharmaceuticals and its consequences on the environment. It is therefore necessary to establish an eco-pharmacovigilance system for monitoring and collection of data, which would eradicate the risk of pharmaceuticals entering into the surroundings.

Keywords: Eco-pharmacovigilance; Environmental Risk Assessment; Organization for Economic Cooperation and Development; Pharmaceuticals.