A Comprehensive System for International Pharmaceutical Company Monitoring of Adverse Drug Reactions

Abstract

During the past two decades, drug surveillance programs have undergone enormous growth. Although the initial development was conducted by universities and regulatory agencies, pharmaceutical manufacturers have joined in both for marketing objectives and for establishing more complete profiles of their products, as required by increasingly stringent governmental regulations. However, unlike the researchers and regulatory bodies that function in a single country, the pharmaceutical industry has encountered problems that relate to their multinational character. These problems prompted the American Cyanamid Company to analyze and revamp its international post-marketing surveillance procedures. In this manuscript we will highlight the findings of our analysis and describe the means we used to resolve the difficulties uncovered.