Report

Keeping Medicines Safe - A Study of the Regulations Guiding the Approval of Medicines in Emerging Markets

This paper has attempted to show, firstly, just how serious a threat substandard and counterfeited medicines are to public health and, secondly, to discuss how the regulations of the production, sale and use of medicines can have an impact on the availability of these dangerous drugs. The paper began by examining the very nature of medical and pharmaceutical regulations: Why are they necessary? What are the concepts and ideas drug regulations are based on? And what are some of the essential best practices? It then moved on to examining how drug regulations have been designed in a number of countries (China, India, Brazil, Argentina and Turkey) which have experienced problems with substandard and counterfeited drugs.

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